Contamination Management Plan

药品非临床研究质量管理规范英文版来源：本站原创更新：2008-7-24 医学英语论坛SDA: Drug Good Laboratory Practices (Transitional)SDA Regulation; Order No.14; Effective Date: 1999-11-01; Repeal Date: 2003-09-01 (Promulgated by Order No. 14 of the State Drug Administration on October 14, 1999, effective as of November 1, 1999,and abolished on September 1, 2003)Chapter Ⅰ-General ProvisionsArticle 1 The provisions are established for improving the quality of non-clinical laboratory studies on new drugs, for assuring the truthfulness, integrity and reliability of experimental data, and for ensuring drug safety for human use pursuant to the stipulations of the Drug Control Law of the People's Republic of China.Article 2 The provisions shall be adapted to non-clinical laboratory studies for applications of drug registration. All non-clinical research organizations shall follow the provisions.Article 3 The terms used in the provisions are defined as follows:1.Non-clinical laboratory study means any toxicity experiments performed under laboratory conditions to evaluate the safety of new drugs, including studies of single dose toxicity, repeated dose toxicity, reproduction toxicity, mutagenic action, carcinogenecity, irritation, dependence and others.2.Non-clinical research organization means the facility which conducts non-clinical laboratory studies of new drugs, including safety research centers, safety research institutes, research laboratories or teams for safety studies, etc.3.Test system means animals, plants, microorganisms or cells used to conduct toxicity studies.4.Quality assurance unit means any unit in non-clinical research organizations that is designed to assure that the study is in compliance with the provisions.5.Study director means the person who is responsible for the overall conduction of a certain study project.6.Test article means any drug or substance to be developed into a drug used to conduct a non-clinical laboratory study.7.Control/reference article means any drug or any other product used in non-clinical laboratory studies for the purpose of establishing a basis for comparison with the test article.8.Raw data mean any materials and original documents or records which record the original research observations, including worksheets, notes, photographs, microfiche or microfilm copies, microcopies, computer printouts, magnetic media, recorded data from automated instruments, etc.9.Specimen means any materials derived from a test system for analysis and examination.10. Sponsor means the unit which commissions the non-clinical research organization to conduct the non-clinical laboratory studies for the test article.11. Batch number means a distinctive combination of numbers and/or letters which can be used to trace and review the production history of the batch of the test or control articles.Chapter Ⅱ-Organization and PersonnelArticle 4 Non-clinical research organizations shall be in compliance with the provisions to establish a well-organized management system. It shall be staffed with a responsible person of the organization, a responsible person of the quality assurance unit and other corresponding personnel, and they shall be managed in accordance with their corresponding responsibilities.Article 5 Personnel of non-clinical research organization shall meet the following qualifications: 1.having prudent scientific style, good professional morality and appropriate education and knowledge, receiving professional training, and possessing job experience and capabilities needed for their assignments;2.familiarizing with the fundamentals of the provisions, strictly performing their assigned duties, skillfully mastering and strictly implementing the Standard Operation Procedures involved in the assignments;3.making records accurately, clearly and on time, and reporting to the study director in written form on anything happening in the experiment that may adversely affect the experimental results;4.dressing according to the needs of their work posts, conforming to requirements of personal sanitation and taking health precautions to avoid the contamination of test and control articles and test systems; and5.taking periodical health examination. Those who are found to have an illness that may adversely affect the reliability of the study shall be excluded from the study.Article 6 The responsible person of the non-clinical research organization shall possess a bachelor or a higher degree on medical, pharmaceutical or other relative specialities. Correspondingly professional qualification and abilities are also required. The responsibilities are as follows:1.taking overall responsibilities and implementing the establishment and organization management of the non-clinical research organization;2.establishing and maintaining current records of education, professional training and job experience for each individual engaged in the non-clinical laboratory studies;3.ensuring that there are various facilities, equipment and experimental conditions in compliance with the provisions;4.ensuring that there are an adequate number of qualified personnel with clear responsibilities and duties and that all of them carry out their work according to the requirements of the provisions;5.designating a responsible person for the Quality Assurance Unit and ensuring that he or she completes the responsibility defined in the provisions;6.making master schedule sheet and monitoring the progress in various studies;anizing the establishment and revision of the Standard Operation Procedures and monitoring the personnel to implement the Standard Operation Procedures involved in their assignments;8.designating a study director before the beginning of each study project. When anyone of them is to be changed, the reasons for and the date of the change shall be recorded;9.reviewing and approving protocols and final reports;10. timely dealing with the reports from the Quality Assurance Unit and recording in detail the measures taken;11. ensuring that the quality and the stability of the test and control articles meet the specification; and12. signing a written contract with the cooperator or the sponsor.Article 7 Non-clinical research organizations shall establish an independent quality assurance unit, the number of personnel of which depends on the size of the research organization. The purpose of the establishment is to assure that the facilities, equipment and management system of the research organization are in compliance with the provisions. The responsibilities of the Quality Assurance Unit are:1. keeping the duplicate of the master schedule sheets, protocols and final reports of the non-clinical research organization;2. reviewing the protocols, experimental records and final reports according to the provisions;3. inspecting and supervising every study project and making a plan for reviewing and inspection based on the study project and its duration. Recording in detail inspection, problems existing and measures taken, signing the name and keeping the records for reviewing;4. inspecting periodically the animal care facilities, experimental instruments and the management of the archives;5. reporting the problems found during the inspection to the responsible person of the organization and the study director on time, proposing suggestions for solving them and writing down an inspection report; and6. taking part in the establishment of Standard Operation Procedures and keeping a duplicate of the Standard Operation Procedures.Article 8 A study director shall be designated in each study project, whose responsibilities are as follows:1. taking whole responsibilities of the routine operations of the study project;2. preparing the protocols, proposing the revision or addition of the corresponding Standard Operation Procedures, analyzing the study results and drafting the final reports;3. complying strictly with the protocols. Any changes shall be approved by the responsible person of the organization;4.assuring that the personnel engaged in the study understand clearly the assignments undertaken and have a good command of the corresponding Standard Operation Procedures;5.monitoring the progress of the study project and inspecting the various experimental records to assure them to be accurate, direct, clear, and on time;6.recording in detail the unforeseen cases during the experiment and the measurements taken for remedy;7.sending the protocols, raw data, specimens which shall be kept, corresponding documentation records and final reports to the archives room after the completion of the experiment; and8.assuring that each step of the study project is in compliance with the requirements of the provisions.Chapter Ⅲ-Laboratory FacilitiesArticle 9 Non-clinical research organizations shall establish corresponding experimental facilities in accordance with the requirements of the provisions and the study project.All kinds of laboratory facilities shall be kept clean and sanitary, and laid out in a rational way to avoid cross contamination. The environmental conditions shall be monitored as needed.Article 10 Non-clinical research organizations shall have animal care facilities designed rationally and allocated suitably. The environmental conditions, including temperature, humidity, air cleanness, ventilation, lighting, etc. shall be controlled according to the needs. Animal care facilities mainly include the following:1.the animal care and management facilities for different genus and species of animals or test systems;2.the facilities for quarantine of animals and for isolation and treatment of diseased animals;3.the facilities for collection and disposal of wastes;4.the facilities for cleaning and disinfection; and5.the corresponding animal care and management facilities that shall be established when test or control articles contain volatile substance, radioactive materials, biohazardous materials, etc.Article 11 Non-clinical research organizations shall have storage facilities for feeds, bedding materials, cages and other articles for animal use. Allocation of various facilities shall be rational, preventing contamination with test system. Proper measures shall be taken for easily decayed and deteriorated articles for animal use.Article 12 Non-clinical research organizations shall have the facilities for handling test andcontrol articles:1.facilities for receipt and storage of the test and control articles; and2.facilities for preparing and storing test and control articles.Article 13 Non-clinical research organizations shall establish corresponding laboratories in accordance with the needs. Specialized laboratories shall be established if biohazardous materials, microorganisms, etc. are handled and used.Article 14 Non-clinical research organizations shall have facilities for storing protocols, specimens, raw data, final reports, relative documentation and records.Article 15 Non-clinical research organizations shall establish facilities for environmental monitoring and control.Chapter Ⅳ-Instruments, Equipment and Experimental SuppliesArticle 16 Non-clinical research organizations shall be provided with the corresponding instruments and equipment according to the study needs. The instruments and equipment shall be suitably located and managed by the authorized person. To assure the stable and reliable performance of instruments and equipment, they shall be inspected, cleaned, maintained, tested and calibrated periodically.The Standard Operation Procedures, indicating the use, the maintenance and calibration of the instruments and equipment shall be provided in the laboratories where the equipment and instruments are placed. The date, the use and the operator's name on operating, inspecting, testing, calibrating and repairing shall be recorded in detail.Article 17 Management of the test and control articles of non-clinical research organizations shall be in compliance with the following requirements:1.The test and control articles of experiments shall be managed by the authorized person and shall be received, registered and distributed according to the procedures. The batch number, stability, content or concentration, purity and other chemical characteristics shall be accurately recorded. In cases where marketed products are used as control articles, such products can be characterized by their labeling or other indications to replace the laboratory analyses.2.The test and control articles shall be stored under suitable conditions. The container storing test or control articles shall be labeled to indicate the name, abbreviation name, code number, batch number, expiry date, and storage conditions.3.Contamination or deterioration shall be avoided during the distribution of the test and control articles. The test and control articles distributed shall be accurately labeled on time. Documentation shall be made for the date and quantity distributed and returned for each batch.4.The uniformity of the mixture shall be determined before administration for each test or control article that is necessary to be mixed with a certain medium. The concentration and stability of the test or control article in the mixture shall also be determined periodically, if necessary. When anyone of the components of the mixture has an expiry date, the date shall be clearly shown on the container. If more than one component have expiry date, the earliest expiry date shall be taken as criterion.医.学全在.线,提供ww w.m ed126.co mArticle 18 The reagents and solutions in laboratories shall be labeled to indicate the name, concentration, storage conditions, preparation date, expiry date, etc. The deteriorated or outdated reagents or solutions shall not be used in the experiments.Article 19 Qualified test animals and feeds shall be selected and adopted. Animal care and management shall be conducted according to the requirements of relevant national regulations concerning test animals.Research results shall not be adversely affected by the use of detergents, disinfectants, pesticides, etc. in animal care room and the name, concentration, method used, date, etc. shall be recorded in detail.The animal feeds and drinking water shall be periodically analyzed to ensure that they comply with the nutrition standards and that the contamination adversely affecting the research results shall be less than the limit specified. The analytical results shall be kept as raw data.Chapter Ⅴ-Standard Operation ProceduresArticle 20 Non-clinical research organizations shall establish Standard Operation Procedures suitable for all experiments as well as guidelines for editing and managing Standard Operation Procedures. Standard Operation Procedures shall include the following:1.receipt, labeling, storage, handling, preparing, ordering, sampling and analyzing of test and control articles;2.animal room and laboratory preparation as well as environmental monitoring and controlling;3.maintenance, repair, calibration, use and management of experimental facilities, instruments and equipment;4.operation and management of computer system;5.transfer, quarantine, numbering and care of test animals;6.observation records and experimental operations of test animals;7.operational techniques, such as collection of test samples, examination, determination of various indexes, etc.;8.examination and handling of animals found to be moribund or dead during study;9.necropsy of animals as well as histopathological examination;10. collection, numbering and examination of experimental specimens;11. the treatment of various experimental data;12. health examination system of personnel;13. edition and management of Standard Operation Procedures; and14. other Standard Operation Procedures which are considered necessary by non-clinical research organizations.Article 21 Standard Operation Procedures shall not be valid until signed and confirmed by the Quality Assurance Unit and approved by the responsible person of research organization. Invalid Standard Operation Procedures shall be destroyed on time except one copy kept.The establishment, revision, valid date as well as distribution and destroying of Standard Operation Procedures shall be recorded and the records shall be well maintained.Standard Operation Procedures shall be stored in the way to assure their convenient use. Any deviations of Standard Operation Procedures shall be approved by the study director and recorded in the raw data. Any significant changes in Standard Operation Procedures shall be confirmed by Quality Assurance Unit and approved by the responsible person of research organization in written form.Chapter Ⅵ-Study ImplementationArticle 22 Non-clinical research organization shall designate a title or code number for each study project and indicate it uniformly in the documentation and experimental records concerned. Specimens collected from experiment shall be identified by study project title or code number, animal number and collection date.Article 23 A written protocol shall be prepared and signed by study director. The protocol shall not be implemented until reviewed by the Quality Assurance Unit and approved by the responsible person of non-clinical research organization. The approval date is defined as the initiation date of experiments. If non-clinical study project is commissioned, the protocol shall be also approved by the sponsor.Article 24 The protocol shall contain the following:1.title or code number of the study project and its purpose;2.the name and address of non-clinical research organization and sponsor;3.the name of study director and researchers engaged in the study;4.the name, abbreviation name, code number, batch number, related physicochemical properties and biological characteristics of the test and control articles;5.justification for selection of the test system;6.the species, strain, number, age, sex, body weight range, source of supply and grade of the test animals;7.the method of identification of test animals;8.the environmental conditions for caring test animals;9.the name and code number of the feeds;10. solvents, emulsifiers and other media used in the studies;11. the route, method, dosage level, frequency and duration of administration of test and control articles as well as the reason for the choice;12. the title of guideline used in toxicity studies;13. the frequency and method of tests, analyses and measurements;14. statistical methods; and15. the location where all experimental data are to be stored.Article 25 If the protocol is necessary to be amended during the study, the amendment shall be reviewed by the Quality Assurance Unit and approved by the responsible person of research organization. The amendments, reasons and date thereof shall be recorded and kept together with the original protocol.Article 26 Study director is responsible for the overall conduction of the study. Personnel engaged in the experiment shall carry out the protocol strictly in compliance with the corresponding Standard Operation Procedures and report on time any abnormalities found during the experiment to the study director.Article 27 All data shall be recorded directly, accurately, legibly, indelibly and on time and shall be dated and signed by the recorder. If any record is to be corrected, the original record shall be legible and the reason for and date of the correction shall be noted, and the records shall be signed by the corrector.Article 28 If animals display diseases caused by the factors rather than test articles or abnormalities interfering the research purpose, the animals shall be isolated and quarantined immediately. If the animals are to be treated with drugs, the treatment shall be approved by the study director, and the reasons, approval procedures, examination, drug prescription, date, result, etc. shall be recorded in detail. The treatment shall not interfere with the research.Article 29 Study director shall prepare a final report and sign it on time after the completion of the study. The final report shall be reviewed by the Quality Assurance Unit and approved by the responsible person of the non-clinical research organization. The approval date is defined as the completion date of the study.Article 30 The final report shall contain the following:1.the title or code number of the study project and its purpose;2.the name and address of non-clinical research organization and sponsor;3.the date of initiation and completion of the study;4.the name, abbreviation name, code number, batch number, stability, content, concentration, purity, components and other characteristics of the test and control articles;5.the species, strain, number, age, sex, body weight range, source of supply, certificate number, certification agency, date of receipt and housing conditions of test animals;6.the route, dosage, method, frequency and duration of administration of the test and control articles;7.justification of dosage levels of the test and control articles;8.the abnormalities that may have affected the reliability of the study and caused the deviation from the protocol;9.the frequency and method of tests, analyses and measurements;10. the names and post assignments of the study director and all researchers;11. statistical methods;12. study results and conclusion; and13. the locations where all raw data and specimens are stored.Article 31 After the final report is signed by the responsible person of non-clinical research organization, if there are corrections or additions to the final report, the parts corrected or added, the date and reasons thereof shall be explained in detail by the responsible person concerned. Such correction or additions shall be confirmed by the study director, reviewed by the Quality Assurance Unit, and approved by the responsible person of non-clinical research organization.Chapter Ⅶ-Data and ArchivesArticle 32 Original protocols, specimens, raw data, records, final reports, documentation concerned with the experiment, inspection report of Quality Assurance Unit, etc. shall be ordered by the study director according to requirements of Standard Operation Procedures and handed to the archives room after completion of the study. They shall be numbered and stored according to Standard Operation Procedures.When the study project is withdrawn or ceased, the study director shall explain the reason in written form and then put in order and keep all the data specified in articles mentioned above in the archives.医学全在线www.med126.c omArticle 33 Archives room shall be under the charge of the authorized persons and shall be managed according to the requirements of Standard Operation Procedures.The retention period of the protocols, specimens, raw data and documentation records, final report and other archives shall last at least 5 years since the drug marketing.Wet specimens, the characteristics of which are liable to be changed, such as tissues, organs, electron microscopic specimens, blood smear, specimens from reproduction toxicity study, etc. shall be retained only as long as the quality of the preparation affords evaluation.Chapter Ⅷ-Supervision, Inspection and CertificationArticle 34 The State Drug Administration is responsible for supervision, inspection and certification of non-clinical research organizations.Article 35 All non-clinical research organizations applying for drug registration in the People's Republic of China shall be regulated under the supervision, inspection and certification. Chapter Ⅸ-Supplementary ProvisionsArticle 36 The State Drug Administration is responsible for explanation of the provisions.Article 37 The provisions shall enter into force on November 1, 1999.。

英语作文-环境风险评估与管控措施研究与案例分享Environmental risk assessment is a critical process in the management of environmental hazards. It involves identifying potential environmental threats and evaluating their possible impact on ecosystems and human health. The ultimate goal is to develop effective control measures to mitigate these risks. This essay delves into the methodologies of environmental risk assessment and shares case studies that highlight successful management strategies.The first step in environmental risk assessment is the identification of hazards. This involves a thorough analysis of the physical, chemical, and biological elements that could potentially cause harm. For instance, a chemical manufacturing plant may release toxic substances into the air and water, posing a threat to nearby communities and wildlife. By recognizing these hazards, stakeholders can prioritize which risks require immediate attention.Once hazards are identified, the next step is to evaluate the likelihood and severity of their impact. This is often done through quantitative methods, such as modeling the dispersion of pollutants or assessing the toxicity levels of chemicals. For example, researchers might use air quality models to predict the concentration of pollutants at various distances from a factory. These models help in understanding the potential exposure levels for humans and the environment.Risk characterization combines the information on hazard identification and impact evaluation to estimate the overall risk. This step considers both the probability of occurrence and the magnitude of consequences. It provides a comprehensive view of the potential environmental damage and forms the basis for developing control measures.Control measures are the actions taken to manage and reduce environmental risks. These can range from technological solutions, such as installing pollution control equipment, to policy interventions, like enforcing stricter emission standards. A casestudy that exemplifies effective control measures is the cleanup of the Hudson River in New York. After decades of pollution from PCBs, a combination of dredging and habitat restoration has significantly reduced the levels of contamination, leading to a healthier ecosystem.Monitoring and review are essential components of environmental risk management. They ensure that control measures are working as intended and allow for adjustments if necessary. Continuous monitoring of environmental indicators, such as water quality and biodiversity, provides data that can inform future decisions and policies.In conclusion, environmental risk assessment and control measures are indispensable tools in the pursuit of sustainable development. They enable us to understand and manage the complex interactions between human activities and the natural world. Through diligent application of these processes and learning from successful case studies, we can protect our environment and ensure a healthy planet for future generations.This essay has explored the intricate process of environmental risk assessment and the importance of implementing robust control measures. By examining real-world examples, it has demonstrated the positive outcomes that can be achieved when risks are managed effectively. The continuous evolution of assessment techniques and control strategies will play a pivotal role in safeguarding our environment against the myriad of risks it faces. 。

Contamination Control PlanforMidshipman Space Technology Applications Research(MidSTAR)-1 SpacecraftRecord of ChangesTABLE OF CONTENTS1.0PURPOSE (1)1.1Scope (1)1.2Applicable and Reference Documents (1)2.0CONTAMINATION CONTROL REQUIREMENTS (1)2.1Surface Cleanliness (1)3.0CONTAMINATION SOURCES FOR SPACECRAFT (2)4.0DESIGN PHASE CONTAMINATION CONTROL (2)4.1Materials Selection (2)5.0FABRICATION AND ASSEMBLY PHASES CONTAMINATION CONTROL (3)5.1Venting Design Requirements (4)6.0INTEGRATION PHASE CONTAMINATION CONTROL (4)6.1Cleanroom and Operational Requirements (4)6.2Vacuum Bakeout Requirements (5)7.0TEST PHASE CONTAMINATION CONTROL (5)7.1 Vibration and Acoustics Testing (5)7.2 Thermal Balance/Thermal Vacuum Testing (5)8.0CONTAMINATION CONTROL DURING TRANSPORTATION AND STORAGE (6)9.0ROLES AND RESPONSIBILITIES (6)10.0CLEANLINESS INSPECTION AND MONITORING METHODS (6)10.1 Cleaning and Monitoring Schedules (7)11.0EMPLOYEE TRAINING (7)12.0CONTAMINATION DOCUMENTATION REQUIREMENTS .. 713.0ACRONYMS and DEFINITIONS (7)13.1 Acronyms (7)13.2 Definitions (8)1.0PURPOSEThe purpose of this Contamination Control Plan (CCP) is to define the overall contamination control requirements for the design, fabrication, assembly, integration and testing of the MidSTAR-1 spacecraft.1.1ScopeContamination control requirements during all phases of the mission will be addressed. Allowable contamination requirements will be presented along with the planned methods for limiting contamination throughout all phases. Plans for analyses, laboratory investigations, cleanroom and hardware monitoring will also be addressed.1.2Applicable and Reference DocumentsThe following subsections list the applicable and reference documents mentioned in this CCP.FED-STD-209 Clean Room and Work Station Requirements, Controlled EnvironmentMIL-STD- 1246 Product Cleanliness Levels and Contamination ControlJSC SP-R-022A Specification Vacuum Stability Requirements of Polymeric Materials for Spacecraft ApplicationsNASA Materials Outgassing Data for Selecting Spacecraft Publication 1124 MaterialsSN-C-0005C Contamination Control Requirements for the Space Shuttle ProgramGSFC-TLS-PR-7324-O 1 Contamination Control Procedures for the Tape Lift Sampling SurfacesASTM E-595 Methods of Test, Total Mass and Controlled Volatile Condensable Materials from Outgassing in a Vacuum EnvironmentIES-RP-CC-018-89-T Cleanroom Housekeeping – Operating and Monitoring Procedures2.0CONTAMINATION CONTROL REQUIREMENTSThe overall Contamination Control program has been developed based on the sensitivities and performance goals of the spacecraft, as well as those of the other spacecraft manifested on STP-1. This section will present baseline contamination sensitivities and requirements. All design, fabrication, assembly, integration, testing, packaging, transportation and integration must be performed in a manner which will minimize the probability of contaminating STP-1 critical surfaces. During many project phases, an active contamination monitoring program will be in effect, using a number of methods including visual inspections, black light and white light measurements, tape lifts and/or witness plates. Outgassing requirements will be met by all subsystems and/or components through proper selection of materials and appropriate vacuum bakeout of parts, components, and subsystems.Generally, assembly and integration will take place in a class 100,000 or better cleanroom environment at USNA. When the instrument is outside of the class 100,000 cleanroom it must be bagged. The only exception is when I&T activities prohibit bagging. Additionally, when flight hardware is not being worked on in the cleanroom it must be protected with a cover or drape. During any type of transportation or storage the satellite will be bagged in approved cleanroom bagging material.2.1Surface CleanlinessSpacecraft molecular and particle surface cleanliness requirements for delivery, beginning-of-Life(BOL), and end-of-Life (EOL) will be evaluated and will be addressed separately. Where contamination levels cannot be measured through contact test methods (e.g. tape lifts), the levels will be inferred through black light inspection or measurement of witness plates maintained in the same environment as the sensitive surface.3.0CONTAMINATION SOURCES FOR SPACECRAFTPossible sources of contamination must be identified in order to protect the spacecraft from contamination and to effectively clean contaminated components. Table 3-1 is a listing of possible contamination sources at the various development stages.Table 3-1 Contamination Sources for Spacecraft4.0DESIGN PHASE CONTAMINATION CONTROLContamination prevention is a basic design consideration and will be examined throughout the development process.4.1Materials SelectionIn order to control contamination and protect sensitive surfaces, the use of minimal contaminating materials and the use of covers and protective shields must be considered. Manufacturing materials should be low outgassing, nonshedding and non-flaking. Generally, materials must meet ASTM E595 “Methods of Test,Total Mass and Collected Volatile Condensable Materials from Outgassing in a Vacuum En vironment” outgassing requirements. Efforts will be made to select low outgassing materials (CVCM level of 0.1% and TML of 1.0% by weight) for all applications. For questionable materials, or materials where data does not exist, it may be necessary to test outgassing characteristics in the GSFC MOLEKIT facility, in accordance with the ASTM E595 procedure.5.0FABRICATION AND ASSEMBLY PHASES CONTAMINATIONCONTROLFabrication of spacecraft parts will generally take place in uncontrolled environments (> Class 100,000 environments); assembly of the spacecraft will take place in a Class 100,000 cleanroom. During all fabrication and assembly phases and associated storage/transportation periods, contamination control measures will be instituted. Surfaces will be kept clean, and if any debris is generated during the manufacturing process it will be cleaned/vacuumed off. During assembly, mating surfaces will be cleaned to visibly clean sensitive prior to attachment. All interior volumes will be cleaned thoroughly prior to final assembly and attachment. Isopropyl alcohol or a 3 to 1 mix of IPA with 1,1,1 -Trichloroethane may be used as a solvent. All ground support equipment will be kept visibly clean during assembly. Any cables, harnesses, etc. will be cleaned before attachment to flight hardware, and if necessary vacuum baked prior to outgassing certification.Spacecraft subsystems will be maintained at a visibly clean level throughout the fabrication process. Trained personnel will perform inspections. Cleanliness requirements during subsystem fabrication are as follows:1. During manufacturing operations such as machining, welding and soldering, contaminants should becleaned off of the hardware by wiping and/or vacuuming. Lubricants and cutting oils (i.e. oils and greases) should be cleaned off as soon as possible after the manufacturing operation using appropriate solvents.2. Prior to priming or painting a surface it should be free of particulate or molecular deposits and beinspected at a visibly clean level.3. If an area becomes inaccessible during fabrication it must be cleaned and inspected to a visibly cleanlevel before becoming inaccessible.4. Upon the completion of a fabrication operation, the components will be subjected to a gross cleaningprocedure involving solvent washes and particulate removal, yielding a visibly clean sensitive product with less than 1 mg/ft2 NVR. Parts with less than 1 square foot of area may be grouped together into one NVR rinse for verification purposes. The fabricated components will then be bagged to negate contamination effects.5. Parts, surfaces, holes and so forth must be cleaned with isopropyl alcohol (IPA) moistened wipes.Wiping should be in one direction only and each pass should be with a clean area on a wipe or using a new wipe for each pass. In some instances wipes will be ineffective and swabs moistened with alcohol maybe used. Cleaning will continue until all surfaces are visibly clean upon inspection.6. Any cleaning of painted surfaces will be done with the approval of the spacecraft contaminationengineer.7. Prior to any final assembly, all surfaces must be vacuumed giving special attention to holes, crevicesand riveted regions.8. Assemblies will be visually inspected with a blacklight for external oil or grease deposits, and if anyare found, the areas will be wiped with IPA moistened wipes, using a clean wipe area for each pass and wiping in one direction.5.1Venting Design RequirementsThe number of vents shall be limited to facilitate thermal vacuum testing. The venting design shall be adequate to provide for launch-ascent depressurization. NASA qualified parts normally meet the minimum vacuum stability requirements. Thermal vacuum bakeout, curing at elevated temperatures, and thermal bakeout are efficient methods of reducing unacceptable outgassing rates to acceptable levels. It is also sometimes possible to justify the use of materials not meeting this requirement by performing a controlled outgassing rate test (ASTM 1559) using the following temperatures: source shall be +10 C over maximum orbit service temperature for the material, TQCM at -10 C under the minimum orbit temperature for the instrument.6.0INTEGRATION PHASE CONTAMINATION CONTROLIntegration of the spacecraft will occur in a class 100,000 environment at USNA. After spacecraft integration the goal will be to keep the instrument in class 100,000 environment. When in a class 100,000 environment the spacecraft must be bagged. Regular monitoring of the cleanroom, GSE, and flight hardware will be accomplished. Exterior spacecraft surfaces will be verified as meeting Visibly Clean Sensitive upon receipt at the cleanroom. The spacecraft will remain bagged whenever operations permit.During downtimes when hardware is not actively being worked on, or for weekends and other non-operational times, flight hardware will be kept covered with an approved cleanroom certified, anti-static bagging material. Bagging materials and drapes must be contamination and electrostatic discharge (ESD) approved. To prevent electrostatic discharge (ESD) damage to any of the electronic components, precautions beyond contamination control measures may be required. This may mean using anti-static packaging films, ESD approved garments and grounded wrist straps. Additionally the temperature and humidity of the work environment will be controlled. Quality Assurance will determine the ESD sensitivity of the hardware.6.1Cleanroom and Operational RequirementsSpacecraft integration will occur in launch site cleanroom facility, which operates at class 100,000 (or better) per Fed. Std. 209. The following list highlights the planned contamination procedures to be implemented during integration activities:1. Parts from a less controlled fabrication and assembly area will be cleaned to a visibly clean levelprior to entry into the clean room.2. All surfaces will be cleaned to Visibly Clean Sensitive throughout integration activities. A solventrinse will be used to verify the molecular levels meet the budgeted requirement.3. Parts which are machined, welded or riveted will be inspected and re-cleaned, if necessary to meetthe Visibly Clean Sensitive levels. A solvent rinse may be used to verify the molecular levels meet the budgeted requirement.4. Personnel working in the cleanroom will wear appropriate cleanroom clothing, shoe coverings, etc.and latex gloves. When working with solvents polyethylene gloves should be worn.5. Ground support equipment (GSE) required for testing will be cleaned with IPA to a visibly cleanlevel, and bagged before going into the cleanroom. Surfaces, which will contact the instrument, must meet the requirements.6. Oils, greases and other similar agents, which may be contamination hazards, will not be used duringintegration without the permission of the materials engineer and contamination engineer.7. Joints or crevices will be covered during integration to minimize the build up of contaminatingdebris. Rivets, bolts, nuts and so forth must be cleaned to remove any type of contamination such as lubricants and machining oils prior to I & T. Fasteners, which are lubricated, will be cleaned with an appropriate solvent prior to being used during integration. Areas which become inaccessible for cleaning must be cleaned and inspected prior to that time, and be bagged following that time.8. All integration GSE, testing equipment, etc. will meet the visibly clean level.9. If an instrument or hardware is removed for testing, or some other reason, it must reverified to acleanliness level visibly clean, highly sensitive before it can reenter the cleanroom.10. The instrument support team is responsible for cleaning and maintaining their respectiveinstruments during satellite integration and testing.6.2Vacuum Bakeout RequirementsAlong with the selection of low outgassing materials for the spacecraft a thermal vacuum bakeout program will be accomplished for the program if required. In general:1. The outgassing rate will be measured during thermal vacuum certification. The materials, parts, andsubsystems will undergo a vacuum bakeout only if they do not meet their outgassing requirement.2. All other structure, materials, assemblies, or components, which may be mounted without MLI orcontrolled venting, will be evaluated on a case-by-case basis to assess the need for vacuum bakeouts.3. A thermal vacuum bakeout, in conjunction with the satellite thermal balance/thermal vacuum testing,will be utilized if the instrument does not meet its outgassing requirements.7.0TEST PHASE CONTAMINATION CONTROLPrior to integration, the spacecraft will be subjected to a number of testing operations. Generally, contamination requirements during the testing phases are identical to those found in Section 7.0, Integration Phase. If a particular test requires the removal of bagging, the personnel who come in contact with the instrument must wear cleanroom clothing, gloves, etc. If solvents are used, polyethylene gloves must be worn. Post testing cleanliness inspections of external surfaces will be performed to assure that surface cleanliness levels have not been exceeded.7.1 Vibration and Acoustics TestingClosed out surfaces of the instrument will be bagged during vibration and acoustic testing except when prohibited by the performance of the test. During periods of inactivity, the instrument will be draped.7.2 Thermal Balance/Thermal Vacuum TestingThe spacecraft will undergo a TB/TV testing sequence, in conjunction with a period of outgassing certification. All tests will be monitored with a combination of the following instrumentation:1. Temperature controlled quartz crystal microbalances (TQCMs),2. Cold fingers and scavenger platesIn addition, cold plates will be used as required to minimize contamination from known high outgassing sources. The spacecraft level thermal vacuum test will be performed at NRL. The chamber will be maintained at a class 100,000 environment. Cleanroom garments will be worn while working within thechamber. The thermal vacuum test will be monitored with a series of TQCMs and with the aforementioned monitoring instrumentation. All temperature transitions will be controlled to minimize contamination.Prior to thermal vacuum testing, the instrument will be cleaned and verified for cleanliness requirements, double bagged, then transported to the thermal vacuum-testing chamber. Prior to loading the instrument into the chamber, the chamber background and ground support equipment outgassing levels will be measured and verified to meet the chamber certification levels.Outgassing certification will be performed during the last hot cycle of thermal vacuum testing. During certification, the flight hardware must be maintained at its maximum on-orbit operation temperature. The hardware-outgassing rate will be measured with two TQCMs for at least eight consecutive hours. The TQCMs must be mounted within the chamber such that the TQCMs have a representative view of the flight hardware. The TQCMs will be maintained at ~50 C and +5 C. If the flight hardware does not meet its outgassing requirements the hardware will be subjected to a bakeout.Following thermal vacuum testing QA and the contamination engineer will visually inspect the cleanliness of the instrument. The structure will be double bagged and transported to the integration facility, or another testing facility. External surfaces will be inspected and verified as meeting integration phase surface cleanliness requirements.8.0CONTAMINATION CONTROL DURING TRANSPORTATIONAND STORAGEThe spacecraft will be bagged during storage or transportation. Subsystems and subassemblies, which do not have any special requirements for handling and storage prior to integration, will be cleaned to a cleanliness level of visibly clean and bagged unless integration or test activities prohibit it. The spacecraft will be bagged with approved bagging material (RCAS 4200 or equivalent) at all times unless integration and test activities prohibit it.The Spacecraft will be bagged and transported in a shipping container. The shipping container will be pre-cleaned, prior to transportation, to a visibly clean level. Temperature and humidity will not be monitored in the shipping container.9.0ROLES AND RESPONSIBILITIESThe Contamination Control Engineer, Systems Engineer, Integration and Test Manager, and Quality Assurance Engineer will be responsible for ensuring that contamination control measures are implemented throughout the design, fabrication, assembly, integration, testing, storage and transportation, and all other phases.10.0CLEANLINESS INSPECTION AND MONITORINGMETHODSCleanliness Inspection methods to be used are witness plates, black and white light inspections, washes, swab sampling and tape lifts. Descriptions of these techniques are as follows:Witness Plates:Witness Plates are used to determine NYR levels, particulate levels and fallout rates. Witness plates collect passively during cleanliness monitoring procedures. Witness plates should be placed as close as possible to contamination sensitive areas, to obtain the most accurate particulate readings.Light Inspections:Visual Inspection is done periodically using black (UV) light or white light, per JSC-SNC005C. Visibly clean, using white light, is the absence of all particulates and nonparticulates visible to the normal unaided eye (except corrected vision). UV inspection light sources are no less than 100 watts and located no more than 50cm from the inspected item. During UV inspection, light from other sources should not be more than 5 ft candles. If visual contamination is evident, the hardware must be cleaned and then reinspected under the same light conditions. If during UV inspection there is any evidence of fluorescence the item/surface must be re-cleaned. If re-cleaning does not reduce the fluorescence, it must be determined whether the fluorescing material is a contaminant or the substrate surface.Molecular Washes/Wipes:A surface which is to be inspected, is washed or wiped with alcohol or an appropriate solvent and the solvent and residue is collected. This collected residue or rinse is then subjected to a quantitative and qualitative analyses and the type of contaminant residue is chemically identified.10.1 Cleaning and Monitoring SchedulesCleaning of flight hardware, GSE, and cleanrooms shall occur on a scheduled basis and as required by activities. The Contamination Control Implementation Plan (CCIP) shall present the planned cleaning and monitoring schedule.11.0EMPLOYEE TRAININGContamination Control and Cleanroom Practices training will be conducted for all personnel involved in the fabrication, assembly, integration, testing, and transportation of the spacecraft. Areas which will be studied in the training sessions are as follows: Definition of contamination and how it affects the mission; the importance of maintaining contamination control in all the program phases from fabrication through launch; reviewing instrument sensitivities; knowledge of the instrument and contamination control plans and related contamination documents; specific techniques for cleaning, inspection, and packaging; monitoring techniques in the cleanroom and in the shipping containers; and cleanroom dressing procedures and rules for working in a controlled cleanroom area.12.0CONTAMINATION DOCUMENTATION REQUIREMENTS There are a number of contamination-related documents, which must be produced and periodically updated throughout the development process. These include:▪ Contamination Control Plan▪ Cleanroom History Logs▪ Hardware Cleanliness History Logs▪ Testing Results Reports13.0ACRONYMS and DEFINITIONS13.1 AcronymsCCE Contamination Control EngineerCCM Contamination Control ManagerCCP Contamination Control PlanCVCM Collected Volatile Condensable MaterialsESD Electrostatic DischargeFED-STD Federal StandardGSE Ground Support EquipmentGSFC Goddard Space Flight CenterHEPA High Efficiency Particulate AirIPA Isopropyl AlcoholI & T Integration and TestMIL-STD Military StandardMLI Multi-Layer InsulationNASA National Aeronautics and Space AdministrationNVR Non-Volatile ResiduePAR Performance Assurance Requirements (Document)QA Quality AssuranceQCM Quartz Crystal MicrobalanceTML Total Mass LossTQCM Temperature-Controlled Quartz Crystal MicrobalanceVCS Visibly Clean Sensitive13.2 DefinitionsCleanroom - Room in which the concentration of airborne particles is controlled to specified limits.Clean Zone - Defined space in which the concentration of airborne particles is controlled to specified limits. Clean zones are classified by a number such as 1, 100, 1000, etc., in accordance with FEDSTD- 209, which describes the maximum number of particles, 0.1 microns and larger, permitted per cubic foot of air.Contamination - Any unwanted material that causes degradation in the desired function of an instrument or flight hardware.Contamination Control - Organized action to control the level of contamination.Fiber - A particle whose length-to-width ratio exceeds 10:1 with a minimum length of 100 microns.Gross Cleaning - Cleaning hardware surfaces to visual inspection standards.Level x per Mil-Std 1246 - The cleanliness level defined by a number and/or letter designating the particle distribution and molecular cleanliness, respectively.Non-Volatile Residue - Soluble material remaining after evaporation of a volatile liquid which usually causes degradation in the desired function of an instrument or flight hardware.Particle - A small quantity of solid or liquid material with definable shape or mass with a length to width ratio less than 10:1.Particle Size - Expressed as the apparent maximum linear dimension or diameter of the particle.Precision Cleaning - A cleaning procedure done in a controlled environment to attain a specific level of cleanliness. This procedure follows gross cleaning.Sensitive Surface - Any surface of flight hardware that must meet a specified cleanliness level toassure the minimum performance levels.Solvent Flushing - Method of cleaning surfaces with a stream of filtered solvent under pressure, which is directed against a surface to dislodge and rinse away any foreign material.Solvent Washes - A quantitative method of verifying MIL-STD-1246 molecular cleanliness levels by measuring molecular contamination in a solvent, which was washed over a surface and collected.Surface Cleanliness Level - An established level of maximum allowable particulate and/or NVR contamination ranging from visibly clean to specific MIL-STD-1246 levels (e.g., Level bOA, Level 300B, etc.).Swab Sample - A qualitative method of identifying contaminants by analyzing the residue on a solvent-soaked swab that was wiped over a surface.Tape Lifts - A quantitative method of verifying MIL-STD-1246 particulate cleanliness levels by measuring particulate contamination on a sample of tape that has come in contact with the surface one wishes to examine.Vapor Degrease - Item to be cleaned is exposed to heated solvent vapors that condense on the part and wash away contaminant.Visibly Clean - The achievement of a clean surface as seen without optical aids (except corrected vision) as measured by a specified method. Three levels of visibly clean (VC) requirements are defined in JSC-SN-C-0005C. Visibly clean is the absence of particles as seen by the unaided eye at the distance and light level specified below.Note 1: One foot-candle (lumens per square foot) is equivalent to 10.76 lumens per square meter.Note 2: Cleaning is required if the surface in question does not meet VC under the specified incident light and observation distance conditions.Note 3: Surfaces other than diffuse white may require additional cleaning to achieve these levels.Note 4: Exposed and accessible surfaces only.Note 5: Initial cleaning is mandatory; Note 2 apply thereafter.9。

Garment management for controlled environments: an introductiongetting startedtestingtypical cleanroom laundry functiongarment management systemscleanroom garmentscontamination control123465the micronclean organisationc o n t e n tMicronclean International was established in the 1980’s to meet the growing need for professional cleanroom clothing management services. Now Micronclean is present throughout the world and has a portfolio of customers in diverse industrial and service organisations.The organisation operates to the highest standards of professionalism, workingwithin the very latest international codes of practice. It is recognised as aninnovator, having contributed significantly to modern cleanroom garmentdesign and management techniques.All Micronclean centres operate from modern premises and witha workforce committed to a ‘right first time’ philosoph y.Objectives and philosophyWe aim to be the best! We are prepared to meet theever increasing technical demands on fabrics, clothing styleproduction and the disciplines required within our processing plants.Only by being the best do we expect to command the respect andfuture business from our customers.The International dimensionMicronclean has but one standard - the highest possible quality.Our procedures are common to all processing plants and our policy ofclosed loop garment management is designed to ensure efficienttracking and optimised asset management irrespective of geographicallocation. One policy, one standard!Communication with customersAll Micronclean companies have a commitment to communicate with theircustomers. The results for garment performance and the processing are both communicated.We help you with the training of your personnel. We keep you informed on international standardsand developments and we help you to find any specific information you might need. Micronclean is putting a lot of effort into the continuous improvement of our communications by using technology (e.g. the internet).Global guaranteeWhen you are served by a Micronclean company, you have the assurance of dealing with a quality global cleanroom solution partner.Uninterrupted serviceEvery Micronclean company has a fully detailed contingency plan with another Micronclean plant to ensure your cleanroom garment needs are always met.Leading edge technologyMicronclean companies undergo a formal technology audit every six months. Then, against a peer group of advanced cleanroom operations from around the globe, quality of output, equipment capabilities and quality systems are analysed, compared and refined.Research and developmentMicronclean International has permanent R&D projects. These projects include all elements of the cleanroom services we offer, be it specific decontamination processes for a certain industry, garment and fabric development. We have our own testing facilities and co-operate with specialised research laboratories where needed. Most of the time we include some of our customers in our R&D projects to combine our know-how with practical experience.Cleanroom solution partnerAll twenty-plus Micronclean companies around the globe share informaton. They are truly partnering with customers to find solutions for all their cleanroom needs. Micronclean International has unparalleled depth to call upon to help find those optimal solutions. We have resources around the globe, with experience in every cleanroom application, classification and service aspect. Micronclean companies lead the industry and can rapidly bring the experience and knowledge to help solve your toughest problem.Low cost providerMicronclean companies benchmark all leading indicators of efficiency and performance on a continuous basis.Copy exactlyMicronclean International understands international customer’s need for identical cleanroom processes across multiple locations. We are uniquely positioned to accommodate “copy exactly” requirements. We speak a common language around the globe and have a support team charged with facilitating cross-site communication. We operate international working groups and an aggressive schedule of cross training and visitation programmes.International standardsMicronclean International has representatives at the standards bodies which impact your business and quality requirements.Micronclean International has the manpower and international reach to stay abreast of developments communicating them promptly around the globe. Micronclean companies meet all recognised standards.Market coveragePrinciple areas of operation include: Microelectronics - Pharmaceuticals - Opticals - Biotechnology -Telecommunications - Aerospace & Defence - Medical devices - Static Sensitive Areas - Hospital Pharmacies - Cosmetics - Food Processing - ...With this brochure Micronclean International provides you a basic knowledge of contamination control and garment management for cleanrooms. We will be pleased to assist with any information you might request.the micronclean organisationHeadquarters:Micronclean International Diedenweg 946717 KV Edethe Netherlandsphone: +31 318 622 484fax: +31 318 630 444info@ Members Europe:AUSTRIAMicronclean AustriaWozabal Sterilgut-Systeme Atterseestraße 974860 Lenzingphone: +43 7672 913 0fax: +43 7672 913 85BELGIUMMicronclean BelgiumScaldis St.Martin36, rue de la Hurtrie7600 Peruwelzphone: +32 69 77 16 25fax: +32 69 77 57 70 DENMARKMicronclean DenmarkBerendsen Textil ServiceVølundsvej 124300 Holbækphone: +45 59 43 22 22fax: +45 59 43 53 72FRANCEMicronclean FranceInitial Services TextilesParc d’activités de Villejust6, rue Lionel Terray91971 Courtaboeufphone: +33 1 69 31 76 80fax: +33 1 69 31 76 89www.initial-btb.frGERMANYMicronclean GermanyBilger-SchwenkStollweg 672760 Reutlingenphone: +49 7121 3121 57fax: +49 7121 3121 21www.micronclean.deHOLLANDMicronclean HollandMicroncleanKoopman Heeresweg 108701 PR Bolswardphone: +31 515 578 990fax: +31 515 578 981www.micronclean.nl IRELANDMicronclean IrelandMicron Clean (Ireland)Spiddal Industrial EstateSpiddal, Co. Galwayphone: +353 91 553 066fax: +353 91 553 068www.micronclean.ieITALYMicronclean – ICS ItalyLinen Supply ItalianaVia Cesare da Sesto 1520123 Milano MIphone: +39 02 89 40 05 23fax: +39 02 89 40 14 93SWEDENMicronclean SwedenBerendsen Textil ServiceRättarvägen 4611 35 Nyköpingphone: +46 155 20 96 00fax: +43 155 28 49 40Micronclean SwedenBerendsen Textil ServiceAxel Danielssons väg 195215 92 Malmöphone: +46 40 36 80 00fax: +46 40 36 80 60UNITED KINGDOMMicronclean NewburyMicroncleanC1 Faraday RoadNewbury, BerkshireRG14 2ADphone: +44 1635 37901fax: +44 1635 31528Micronclean SkegnessMicroncleanRoman BankSkegness, LincolnshirePE25 1SQphone: +44 1754 767377fax: +44 1754 610344Members America:BRAZILMicronclean – ICS BrazilALSCO Toalheiro BrasilRua Conde de Itú, 87504741-001 São Paulophone: +55 11 5523 8722fax: +55 11 5523 6961USAMicronclean – ICS USAAmerican Cleanroom GarmentsP.O. Box 82269Portland, OR 97282-0269phone: +1 503 233 5445fax: +1 503 235 0509Micronclean – ICS USAAmerican Cleanroom Garments971 Northpoint BoulevardWaukegan, IL 60085-8214phone: +1 847 473 1200fax: +1 847 473 4595Micronclean – ICS USAAmerican Cleanroom GarmentsServitex Cleanroom Services3 Yadkin StreetDurham, NC 27703phone: +1 919 957 9800fax: +1 919 957 0403Members Australia:Micronclean – ICS AustraliaClean Room Products1 Carlotta StreetArtamon NSW 2064Sydneyphone: +61 2 9439 3622fax: +61 2 9437 4351Micronclean InternationalContamination control is a key element in the concept of the zero defect philosophy employed by an increasing number of modern production and service organisations.Few productive entities escape the need for close attention to contamination control. Gone are the days when cleanroom concepts were confined to ‘leading edge’ space and biological developments. The cleanroom philosophy can now be found in production environments as diverse as vehicle finishing and food processing where all important added value factors are reliant on quality and performance.1.1.The nature of contaminationContamination can be considered as anything which has an effect on the quality or performance of something beingcreated. Contaminates can take the form of particulate, biopollutants, chemical cross-contamination or electrical charges (ESD), which individually or collectively can have a deleterious effect on product or process performance.That such contaminates can be of infinitesimally small or of surprisingly large proportion - as small as 0,1 micrometers in the case of particulate or as high as 0,1 Amp in ESD terms - makes the task all the more challenging. Furthermore, no single element can be considered in isolation. The integrity of any process is only as strong as its weakest link, be that in the operating environment, the logistics including style, composition and comfort of clothing or in the inherent disciplines which must be maintained throughout the cycle.By working within a controlled area like a cleanroom, some pollutants can be filtered out, others eliminated by improvements in the production environment. Airborne particles - skin, fibres, bacteria - pose the greatest challenge.1.2.Different contaminantsWhilst there are many different potential contaminants, these four pose the greatest threat:1.2.1.DustIn this context this can be considered as skin shed by operatives orparticulate matter brought into the production area from outside either by operatives or through poorly filtered purging air. (fig. 01)1.2.2. BacteriaIn the broadest sense this embraces not only particulate and chemical pollutants likely to affect the quality of production but also the health of operators. Thus production chemicals and incoming air must be strictly controlled. This is mainly a problem for pharmaceutical and food processing industries. (fig. 02)1contamination controlfig. 01fig. 021.2.3.ChemicalsPotential cross-contamination from process-to-process or from bodies, garments or equipment entering the controlled environment.1.2.4.Electrical chargeStatic electricity is a contaminant causing possible problems in all areas of cleanroom activity. Polyester cleanroom garments produce static electrical charge as fabric is in contact with fabric or with garments worn under the cleanroom garments. Electrical charges of many thousands of volts may be present on the garments during use. The charge may be discharged at any time to the cleanroom structure, articles or products in the cleanroom. Discharges of static electricity may cause problems in the following ways:- Microelectronics:the discharge of static electricity may damage sensitive products such as microchips and disc drives.Discharges of static electricity occur so rapidly that current flow for a short duration may be highenough to damage products. Damage may weaken components causing premature failure.- Pharmaceuticals:these cleanrooms are not normally associated with products that are damaged by electrostatic discharge, however many pharmaceutical cleanrooms require protection:-Protection against explosion caused by spark discharges-Protection against damage to sensitive microelectronic measuring equipment-Protection against attraction or repulsion of micro-organisms by electrically charged cleanroomgarment fabrics.1.3.CleanroomsThe history of cleanrooms starts during World War II. Indeed during the assembly of the first atomic weapons, it was found that some of the problems were related to dust. The idea of the HEPA (High Efficiency Particulate Air Filter) was introduced in an air-conditioned environment.A next step in the development of cleanroom techniques was the space race. Dust particles causedproblems in the liquid oxygen release valves in the rockets. This introduced a researchprogramme to develop precision component assembly methods. This programme led tothe laminar flow cleanroom.Microelectronics and the pharmaceutical industries started using cleanrooms in the60’s and 70’s. Since the 80’s other industries became interested in theadvantages of cleanrooms for their critical production processes. Now we findcleanrooms in such diverse industries as: opticals; biotechnology; tele-communications; aerospace & defence; medical devices; static sensitive areas;hospital pharmacies; cosmetics; food processing; ... Cleanroom concepts alsofound their way into the modern operating theatres.A cleanroom is an enclosed space served by HEPA filtered air at positivepressure. In view of the major threat to the ‘clean’ environment posed byhumans, the area should preferably be unpopulated by operators - obviously notalways possible.Modern cleanrooms are extremely efficient in reducing contamination but there areno standard solutions. Each industry and location has its own priorities. To a micro-electronics specialist the problem of static electricity is probably as critical as particulate contamination; to a micro-biological company the attendant risk might well come from the danger from toxins or explosion. Each project must be the subject of individual risk assessment.Logically, the current trend is towards compact, localised cleanrooms or compartmentalised workstations for essential clean working rather than large volume coverage. This approach is most flexible, controllable and economical.Whilst much has been achieved in the design of production benches and equipment, such elements now contribute about half the pollution, the balance being from incoming air, gases, chemicals and people.RARASADisplacementRARATurbulentSADisplacement1.4.Basic cleanroom conceptsModern cleanrooms fall into two principal categories:- Unidirectional cleanrooms (fig. 03).The airflow in this type of cleanroom is often vertical. The air flows downwards through HEPA or ULPA (Ultra LowPenetration Air) filters located in the ceiling and is extracted through perforated flooring or grilles mounted in the walls at floor level. Airflow in unidirectional cleanrooms may also be horizontal when the air flows through a full wall of filters and is extracted through returns in the opposite wall. Horizontal airflow is used in applications where operations with stringentcleanliness requirements take place close to the wall of filters and operations with decreasing cleanliness requirements take place “downstream” (meaning further away from the filter wall).- Non-unidirectional cleanrooms (fig. 04).In this type of cleanrooms the air flows from HEPA or ULPA filters located in various positions and is returned throughopposite locations. Filters may be distributed at equal intervals throughout the cleanroom or grouped over critical areas.Because of the distribution of the filters and returns, the airflow may be turbulent in nature.In several cleanrooms a combination of both types can be found.HorizontalRAVerticalSARAHorizontalSA RAVerticalSARAfig. 04fig. 03The classification of the cleanroom environment is determined by the number of particles of a given size in a cube of air at any moment. Fig. 05 illustrates the established standard classifications for controlled environments. These form part of internationally accepted working practices detailed elsewhere in this publication.Class limits (particles/m3)ISO 14644-1Fed Std. 209E0,1 µm0,2 µm0,3 µm0,5 µm 1 µm 5 µmISO Class 1101=102ISO Class 2102=10024104ISO Class 3Class 1103= 1.000237102358ISO Class 4Class 10104=10.000 2.370 1.02035283ISO Class 5Class 100105=100.00023.70010.200 3.52083229ISO Class 6Class 1.000106=1.000.000237.000102.00035.2008.320293ISO Class 7Class 10.000352.00083.200 2.930ISO Class 8Class 100.000 3.520.000832.00029.300ISO Class 935.200.0008.320.000293.000 fig. 05: Airborne particulate cleanliness classes1.5.Cleanroom standardsThe construction and operation of cleanrooms is subject to a number of international standards and recommendedpractices.The first standard on cleanrooms was the American Federal Standard 209, which has been revised several times. The role of this Federal Standard will be taken over by the international standard ISO 14644.For the operation of cleanrooms several standards and recommended practices have been developed by standardisation bodies such as ISO and CEN or controlled environment organisations such as IEST , FDA, ... In most cases these organisations are related to a specific industry, e.g. HACCP for the food processing industry, GMP for the pharmaceuticals, ...1.6.The human elementBetween 40 % and 80 % of contamination can be traced to human operatives working in cleanrooms.The threat posed by human intrusion into cleanrooms is obvious - each of us sheds our outer layer of skin approximately every week in the form of loose particles (about 4/5 micrometers) or groups of cells typically 25/30 micrometers or larger. Abrasion can grind these into a fine powder, using convection to issue these particles - some of which contain chemical or bio residues - into the atmosphere.Fig. 06 shows the particulate shed by humans during a range of activities.Sex, age, temperature differentials and patterns of activity all have a bearing on the rate of issue, as do contaminantsfrom clothing, cosmetics and personal hygiene.100.000500.0001.000.0002.500.0005.000.00010.000.00015.000.00030.000.000fig. 061contamination controle of specialist clothingThe human body creates its own micro-environment of potentially damaging particulate contamination (fig. 07). Since humans are essential to production situations, damage limitation through the use of purpose-designed cleanroom clothing has proved to be the most practical solution to the problem.The use of specialist clothing is now commonplace. To be effective it must:-form a particulate barrier for the human micro-environment-allow freedom of movement and be comfortable-address any specialist requirement, e.g. static dissipation-avoid being a significant particulate contributor itselfDetails of parameters for garments includingthose for the head, torso and feet are included insection 2 of this publication.fig. 072.1.Garment materialsAs mentioned in the previous section, people are one of the greatest contaminants in a controlled environment. Therefore we need specialised garments to protect the environment and the workplace from the human contaminant.Cleanroom garments are unique as they must meet specific protection criteria. This involves special materials, particular construction and individual styling. They must be comfortable, easy to apply and practical in use.Inevitably the result is a compromise between ‘wearability’ and optimum ‘barrier efficiency’. The overriding function is containment of particulate matter. The contaminant should be retained within the garment and not released into the surrounding atmosphere. Of course the garment itself should not create any contaminants.In some cases additional requirements for protection are needed depending on the actual use of the garments and the situation in the cleanroom. These requirements can include ESD characteristics, protection against flames or chemicals, ...The fabrics must:(a)be low shedding (b)permit the body to breathe whilst trapping particles within the garment (c)be flexible enough for comfortable wearing (d)withstand repeated cleaning / sterilisation cycles (e)meet any specific requirements like control of static (f)meet the opacity requirements (g)look and feel as good as possible (h)be cost-effectiveThere are 3 broad categories of fabric used in the construction of cleanroom garments.These include:- woven fabrics- laminated or membrane fabrics- disposable or limited life materials2.1.1.Woven fabricsFirst of all there is the choice of the fibre material. Since the garmentsshould not shed particles, it is obvious that the fibres need to be continuous.This excludes all natural fibres since all of these have a limited length(e.g. cotton fibres have an average length of 30 mm). Polyester still has thebest characteristics for use in cleanroom conditions (see further in this section).Fig. 08 shows a cotton fabric - fig. 09 is a polyester cleanroom fabric.Woven or re-usable fabrics are the most commonly used fabrics in cleanroom environments. As the name implies, they are woven on sophisticated looms from yarns of continuous filaments of polyester. The thickness of the yarn and filaments is important (the finer the yarn the tighter the weave can be made and the better the filtration), but also pattern and tightness of the weave isimportant to reduce the pore size to a minimum. The use ofcontinuous filament polyester means that there are few loose endsfrom which particles may be shed.2cleanroom garmentsfig. 08fig. 09The weave is critical to the trade-off between desired filtration andcomfort. The yarn must be closely and consistently woven to provide a consistentfabric pore size ... too small a pore size will cause wearer discomfort throughinability of the fabric to ‘breathe’ and emit vapour; too large and the garmentbecomes an ineffective filter.Plain weave(fig.10)produces a tighter fabric and good results under test buttight bending of the yarns can lead eventually to damageand particulate flaking.Twill weaves (fig.11) produce less stressing andshow superior results in ‘body box’ testingwhich simulates normal use.Calendered woven fabrics are another optionin which the fabric surface is flattened afterweaving under (heated) rollers to produce ashiny finish. This can, however, affect thebreathing characteristics and is subject topore re-opening after prolonged use.minated fabricsLaminated fabrics, favoured for some high grade microelectronicenvironments, are produced by bonding together 2 or more layers (often acombination of woven and non-woven fabrics) (fig. 12). Particle retention andvapour permeability are achieved by incorporating a membrane that will givethe filtration required. The lamination is a critical process in the productionof these materials.To work efficiently garments from these materials require optimum sealing atall openings, making production relatively expensive.2.1.3.Disposable or limited use fabricsThe most common of these non-woven fabrics are from spun bonded olefin and polypropylene. Comprising a densely interlinked matt of fibres, these can provide good results for a limited period.Garments from such materials need to be processed and decontaminated before use in the cleanroom.Disposable or limited use garments are mainly used in those environments where protection of the wearer against potentially hazardous products are required. A typical example is an environment where toxic chemicals are used. Other applications for these garments are situations where the process would ruin re-usable garments, such as working with certain inks, or where the wearer is on a one-off visit to the cleanroom.Widespread use is seldom cost-effective but in low frequency applications where a managed cleaning cycle is unwarranted or where there is a casual requirement for units off-the-shelf, the disposal concept may prove perfectly viable.2.1.4. Coping with Electro-Static DischargeAlmost all modern cleanroom fabrics have a “grid” of conductive yarns woven into the fabric. These yarnscontain carbon or other electrically conductive material so that the fabric becomeselectrically conductive. The conductive yarns may have the conductivematerial exposed, partially encapsulated or totally encapsulated in a nonconductive polyester (fig. 13).It was thought that garments manufactured from suchfabric would discharge to “earth” if connected to a groundingpoint in the work area. The methods commonly used are by a wriststrap or by use of an electrically conductive floor and electricallyconductive soled footwear. Garments manufactured by traditional fig. 13methods prove difficult to electrically connect to ground and thisapproach, at best, reduces electrostatic charge from several thousandvolts to several hundred volts. In the past this degree of control wasadequate and still is in some applications, but as products have becomesensitive to voltages as low as 25 volts, more effective control is required. In these cases thedesign and construction of the garment will require special attention.2.2.Garments2.2.1.Design and constructionFor the design and construction of the garments the same basic requirements as the fabrics apply. Indeed, a performing fabric does not necessarily mean that the garments made up in this fabric will meet the requirements for use in controlled environments.A garment produced purely for maximum protection would be made out of one piece of material, without seams andcovering the whole body. Clearly this is impractical, if only because of personal size and shape differences. Normally the design will, nevertheless, feature the minimum of seams and closures, no pockets, belt pleats or tucks and be configured to reduce abrasion against skin and any under clothing.Seams must be constructed in such a way that they do not allow air flow through them and thus keep the particles inside the garment. They must also encapsulate the raw edges of the material. Raw edges should be prepared (e.g. heat sealed or encapsulated) to prevent fibres fraying.Since the performance of the garment equals the performance of the weakest part, all materials used in the garment (sewing thread, zips, studs, knitted material for cuffs, ...) must meet the basic requirements individually. This means that e.g. the sewing thread must also be a polyester filament yarn or the zip must resist repeated sterilisation cycles.The design of the garment system must be such that air currents generated by the natural movements of the wearer and trapped by tightly woven fabrics do not pass readily through garment closures. This means that particular attention needs to be paid to fitting around the face of hoods, garment closures and fitting at neck, wrists and ankles. The better fitting and more flexible the garment, the less this 'pumping' action and air compression. This means careful selection of materials, careful styling and the availability of a suitable range of size options.To combat static dissipation the garment construction may require adding conductive tapes to the seams, earthing studs and/or specific sole material and cuffing for full effectiveness.Garment systems may include several layers of garments, depending on the extent of the control required. Generally more layers mean more protection. Choosing the right inner layer can also improve the comfort of the wearer and thus lead to improved working conditions.Most cleanroom garments are unisex, produced in a wide range of sizes and with possible options to suit most male and female requirements off-the-shelf. This reflects the need for cost-effectiveness whilst offering the choice required to ensure suitability for purpose.。

环境污染及解决办法英语作文全文共3篇示例，供读者参考篇1Environmental Pollution and SolutionsOur planet Earth is a remarkable place, blessed with an abundance of natural resources and a rich tapestry of ecosystems. However, as human civilization has progressed, we have inadvertently caused significant damage to the environment through various forms of pollution. As a concerned student, I feel compelled to address this pressing issue and explore potential solutions.Air pollution is one of the most pervasive and detrimental forms of environmental degradation. The burning of fossil fuels, industrial emissions, and vehicular exhaust have led to a dramatic increase in the levels of harmful gases such as carbon dioxide, nitrogen oxides, and sulfur dioxide in the atmosphere. These pollutants not only contribute to global warming and climate change but also pose serious risks to human health, causing respiratory illnesses and exacerbating conditions like asthma and lung cancer.Water pollution is another grave concern that threatens the integrity of our aquatic ecosystems. Industrial effluents, agricultural runoff, and improper disposal of waste have contaminated rivers, lakes, and oceans with toxic substances, rendering them unfit for consumption and posing a threat to aquatic life. The presence of plastic waste in water bodies is particularly alarming, as it can take centuries to decompose and has devastating effects on marine life.Land pollution, often overlooked, is equally detrimental to the environment. Improper waste management practices, such as open dumping and uncontrolled landfills, have led to the contamination of soil and groundwater. This not only affects the fertility of the land but also poses risks to human health through the contamination of food sources and water supplies.Addressing these forms of pollution requires a multifaceted approach involving collective efforts from governments, industries, and individuals. Firstly, we must transition towards cleaner and more sustainable sources of energy, such as solar, wind, and hydroelectric power. This shift will not only reduce our reliance on fossil fuels but also mitigate the emission of greenhouse gases and other pollutants.Secondly, stricter environmental regulations and enforcement measures should be implemented to hold industries accountable for their emissions and waste management practices. Incentives and tax breaks can be offered to encourage businesses to adopt eco-friendly technologies and processes, while hefty fines should be imposed on those who violate environmental regulations.Thirdly, educational campaigns and awareness programs are crucial to fostering a culture of environmental stewardship among the general public. By educating individuals about the impacts of their actions and providing them with practical guidelines for reducing their carbon footprint, we can empower them to make more sustainable choices in their daily lives.On an individual level, we can all contribute to the solution by adopting eco-friendly habits. Simple actions such as reducing energy consumption, recycling, and minimizing the use of single-use plastics can have a significant cumulative impact on the environment. Additionally, we can support environmentally conscious businesses and products, and advocate for environmentally friendly policies in our communities.Furthermore, governments should invest in research and development of innovative technologies that can help mitigateand reverse the effects of pollution. This includes advanced filtration systems for water treatment, carbon capture and storage technologies, and efficient waste management solutions.It is also important to recognize the interconnectedness of environmental issues and address them holistically. For instance, deforestation not only contributes to air pollution and soil erosion but also disrupts the delicate balance of ecosystems, leading to biodiversity loss. By promoting sustainable forestry practices and reforestation efforts, we can combat multiple environmental challenges simultaneously.In conclusion, environmental pollution is a complex and multifaceted issue that requires a concerted effort from all stakeholders. By embracing sustainable practices, implementing robust environmental policies, and fostering a culture of environmental stewardship, we can pave the way for a cleaner, healthier, and more resilient planet for ourselves and future generations. As students, we have a unique opportunity to educate ourselves, raise awareness, and advocate for change, ensuring that our actions today contribute to a better tomorrow.篇2Environmental Pollution and SolutionsWe live on a beautiful planet, a vibrant world teeming with incredible biodiversity and natural wonders. From the lush rainforests of the Amazon to the majestic peaks of the Himalayas, our Earth is a masterpiece of evolution. However, in recent decades, humanity's relentless pursuit of progress and development has come at a severe cost – the degradation of our environment through pollution.Pollution is a grave issue that affects every aspect of our lives, from the air we breathe to the water we drink and the soil that nourishes our crops. It is a multifaceted problem withfar-reaching consequences, threatening the very existence of countless species, including our own. As students, it is our responsibility to understand the causes, effects, and potential solutions to this pressing challenge.Air pollution is one of the most visible and detrimental forms of environmental contamination. The burning of fossil fuels for energy production, industrial processes, and transportation releases vast quantities of harmful substances into the atmosphere. These pollutants include carbon monoxide, sulfur dioxide, nitrogen oxides, and particulate matter, all of which contribute to the formation of smog, acid rain, and greenhouse gas emissions. The effects of air pollution are severe, leading torespiratory diseases, cardiovascular problems, and even premature deaths.Water pollution is another critical issue that demands our attention. Industrial effluents, agricultural runoff, and improper waste disposal contaminate our rivers, lakes, and oceans with toxic chemicals, heavy metals, and pathogens. This not only poses a threat to aquatic ecosystems but also compromises the quality of our drinking water and food supply. Plastic pollution, in particular, has become a global crisis, with millions of tons of plastic waste ending up in our oceans every year, causing immense harm to marine life.Soil pollution is often overlooked but equally devastating. The excessive use of pesticides and fertilizers, improper waste disposal, and industrial activities have led to the contamination of soil with hazardous substances. This not only affects the fertility of the land but also enters the food chain, posing serious risks to human health and the environment.As students, we cannot afford to ignore these pressing issues. We must take action and become agents of change, advocating for sustainable practices and promoting environmental awareness. Here are some potential solutions that we can embrace and encourage:Promoting renewable energy sources: One of the most effective ways to combat pollution is to transition away from fossil fuels and embrace clean, renewable energy sources such as solar, wind, and hydroelectric power. By supporting and advocating for policies that incentivize the development and adoption of these technologies, we can reduce our carbon footprint and mitigate the impact of greenhouse gas emissions.Encouraging sustainable transportation: Transportation is a major contributor to air pollution, particularly in urban areas. By promoting the use of public transportation, carpooling, cycling, and walking, we can significantly reduce emissions from personal vehicles. Additionally, advocating for the development of electric and hybrid vehicles can further minimize the environmental impact of transportation.Supporting recycling and waste management initiatives: Proper waste management is crucial in combating pollution. By actively participating in recycling programs and advocating for better waste disposal systems, we can reduce the amount of waste that ends up in landfills or polluting our environment. Furthermore, supporting initiatives that promote the reduction and reuse of materials can significantly decrease the demand for raw resources and the associated pollution.Raising awareness and educating others: As students, we have a unique opportunity to influence our peers, families, and communities. By participating in environmental campaigns, organizing awareness events, and sharing knowledge about the impacts of pollution and the importance of sustainability, we can inspire others to adopt eco-friendly practices and make informed choices.Supporting sustainable agriculture: The excessive use of pesticides and fertilizers in conventional agriculture contributes significantly to soil and water pollution. By promoting and supporting organic farming methods, which prioritize the use of natural and environmentally friendly practices, we can reduce the reliance on harmful chemicals and protect our vital resources.Participating in reforestation and conservation efforts: Deforestation is a major contributor to environmental degradation, leading to loss of biodiversity, soil erosion, and increased greenhouse gas emissions. By actively participating in reforestation projects and supporting conservation efforts, we can help restore and protect our precious ecosystems, which play a crucial role in mitigating the effects of pollution.Advocating for stronger environmental regulations: While individual actions are essential, systemic change is also necessaryto combat pollution effectively. As students, we can raise our voices and advocate for stricter environmental regulations, holding corporations and governments accountable for their actions. By supporting policies that prioritize sustainability and environmental protection, we can create a framework for lasting change.Environmental pollution is a complex and multifaceted challenge that requires a collective effort from all sectors of society. As students, we have the power to shape the future and create a more sustainable world for ourselves and future generations. By embracing environmentally conscious practices, advocating for change, and inspiring others to join the cause, we can overcome the challenges posed by pollution and protect the delicate ecosystems that sustain life on our planet.Let us not be mere bystanders in this critical battle. Instead, let us become champions of environmental stewardship, using our knowledge, passion, and determination to create a cleaner, greener, and more resilient world. Our actions today will echo through the ages, shaping the destiny of our planet and ensuring a thriving future for all life on Earth.篇3Environmental Pollution: A Global Crisis and Potential SolutionsAs a student deeply concerned about the future of our planet, I can't help but feel a sense of urgency when it comes to the issue of environmental pollution. It is a global crisis that has far-reaching consequences, not only for the present generation but also for generations to come. The Earth, our home, is facing unprecedented challenges, and it is our collective responsibility to address them head-on.The scale of environmental pollution is staggering. From the air we breathe to the water we drink, and the land we inhabit, every aspect of our environment is under threat. Air pollution, caused by the emission of harmful gases and particulate matter, is a major contributor to respiratory diseases and climate change. Water pollution, resulting from the discharge of industrial effluents, agricultural runoff, and improper waste disposal, is contaminating our rivers, lakes, and oceans, threatening aquatic life and human health.Land pollution, caused by the accumulation of solid waste, toxic chemicals, and deforestation, is degrading our soil quality and destroying natural habitats. The consequences are severe,ranging from biodiversity loss to food insecurity and the exacerbation of climate change.The root causes of environmental pollution are multifaceted, but they can be largely attributed to human activities, such as industrialization, urbanization, and unsustainable consumption patterns. As the world's population continues to grow, and economies expand, the demand for energy, resources, and consumer goods has skyrocketed, placing immense pressure on the environment.While the challenges are daunting, there is hope. Solutions exist, and it is up to us, as individuals, communities, and nations, to embrace them wholeheartedly. One of the most effective strategies is the adoption of renewable energy sources, such as solar, wind, and hydroelectric power. By transitioning away from fossil fuels, we can reduce our carbon footprint and mitigate the effects of climate change.Sustainable agriculture practices, such as organic farming, crop rotation, and efficient water management, can help minimize the use of harmful pesticides and fertilizers, reducing water pollution and preserving soil quality. Effective waste management systems, including recycling, composting, andproper disposal of hazardous materials, are crucial in combating land pollution.Education and awareness are powerful tools in the fight against environmental pollution. By promoting environmental literacy and encouraging sustainable lifestyles, we can inspire individuals to make conscious choices that reduce their environmental impact. Simple actions, such as reducing energy consumption, minimizing single-use plastics, and supporting eco-friendly products, can collectively make a significant difference.Governments and policymakers play a vital role in addressing environmental pollution. Implementing and enforcing strict environmental regulations, investing in clean technologies, and promoting green initiatives can drive positive change on a larger scale. International cooperation and collaboration are essential, as environmental challenges transcend national borders.Furthermore, corporations and businesses must embrace sustainable practices and take responsibility for their environmental footprint. By adopting eco-friendly production methods, implementing waste reduction strategies, and investing in green technologies, they can not only contribute toenvironmental preservation but also gain a competitive advantage in an increasingly eco-conscious market.As students, we have a unique opportunity to be agents of change. We can start by educating ourselves and our peers about the consequences of environmental pollution and the available solutions. Participating in environmental clubs, organizing awareness campaigns, and advocating for sustainable policies within our schools and communities can inspire collective action.Moreover, we can be conscious consumers, supporting businesses that prioritize environmental sustainability and holding those that fail to do so accountable. By making informed choices and using our voices, we can influence the market and drive positive change.In conclusion, environmental pollution is a complex and multifaceted issue that requires a concerted effort from all stakeholders. As students, we have the power to shape the future by embracing sustainable practices, advocating for positive change, and inspiring others to join the fight against environmental degradation. Together, we can create a world where clean air, pure water, and a thriving ecosystem are not mere aspirations but a reality for generations to come.。

实验室安全培训及准入制度英文1. Laboratory -实验室2. Safety -安全3. Training -培训4. Admission -准入5. System -制度6. Hazard -危险7. Equipment -设备8. Procedures -程序9. Emergency -紧急情况10. Protocol -协议11. Protective -保护性的12. PPE (Personal Protective Equipment) -个人防护装备13. Chemicals -化学物品14. Fire -火灾15. Electrical -电气的16. Biological -生物性的17. Radiation -辐射18. Cleanup -清理19. First aid -急救20. Contamination -污染21. Incident -事故22. Compliance -遵守1. Laboratory safety training is mandatory for all personnel.实验室安全培训对所有人员来说是强制性的。

2. The laboratory admission system ensures that only authorized individuals can enter.实验室准入制度确保只有授权人员可以进入。

3. Hazardous substances require proper handling and protective equipment.危险物质需要进行适当的处理和使用保护装备。

4. Emergency procedures should be clearly communicated to all laboratory personnel.紧急情况的程序应该明确地向所有实验室人员传达。

5. It is important to follow the protocol when working with potentially dangerous materials.在使用潜在危险材料时，遵循协议非常重要。

巴西药品验厂标准中英文版随着全球化的加速和互联网的普及，药品的生产和流通已变得更加国际化。

为保障药品质量和安全，各国政府及国际组织发布了相关标准和规范，其中就包括各国的药品验厂标准。

本文将介绍巴西的药品验厂标准及其中英文版。

一、巴西药品验厂标准简介巴西药品验厂标准（GMP）由巴西国家卫生监管机构（ANVISA）制定，旨在规范药品生产企业的生产质量管理体系，保证生产的药品符合质量要求。

GMP包括药品生产、质控、生产车间、设备、清洁和消毒、人员、文件管理等方面，对药品生产一环环的环节进行了详细而全面的规范。

根据巴西药品验厂标准，药品生产企业应当遵守以下规定：1. 药品生产应当从原材料到成品整个生产过程全部有记录，详细记录每一批次的物料来源和生产过程，确保生产过程的可追溯性。

2. 企业应当设定质量目标，并建立质量管理体系，实行规范化的操作程序，确保生产的药品符合质量要求。

3. 药品生产现场应当设置清洁区、半清洁区和不洁区，在不同的区域内进行物料的存储和处理，以确保药品的生产环境清洁，并防止杂质、粉尘和微生物污染。

4. 生产车间应当实行定期消毒，设备应当进行维护和检修，并负责人员应当经过严格的培训和考核，以确保药品的生产过程符合标准。

5. 药品生产企业应当建立完善的文档管理制度，确保所有的记录和报告与药品生产相关的信息得到妥善的记录和保存，方便随时查阅和复查。

二、巴西药品验厂标准的中英文版为帮助国内药品生产企业了解巴西药品验厂标准，以下是GMP的中英文版原文：中文版：1. 规范化制造1.1 企业应确保药品生产符合质量管理标准，以确保药品质量。

1.2 企业应建立质量管理体系，明确质量目标、质量政策。

1.3 企业应制定目标和质量计划，监控和管理质量，确保符合质量要求。

1.4 企业应建立并完善质量管理文件，包括：制造规程、质量记录和报告。

2. 生产环境2.1 企业应确保药品生产环境符合卫生要求，不产生杂质和微生物污染。

食品企业过敏原管理计划评审报告英文回答：Food companies need to have an effective allergen management plan in place to ensure the safety of their products and protect consumers with food allergies. As a food safety consultant, I recently conducted a review of a food company's allergen management plan and would like to share my findings and recommendations.Firstly, the company's allergen management plan was comprehensive and well-documented. It included procedures for identifying and controlling allergens at each stage of the production process, from ingredient sourcing to packaging. The plan also outlined the responsibilities of each department involved in allergen management, such as purchasing, production, and quality control.However, during my review, I noticed a few areas where improvements could be made. One issue was the lack of clearlabeling on some of the ingredient containers. This could potentially lead to cross-contamination and pose a risk to allergic consumers. I recommended that the company implement a system to ensure that all ingredient containers are properly labeled with allergen information, including any potential cross-contact risks.Another area for improvement was the training provided to employees. While the company had a training program in place, it lacked practical hands-on training and focused mainly on theoretical knowledge. I suggested that the company incorporate more practical training sessions, such as mock allergen spill clean-up drills, to ensure that employees are well-prepared to handle allergen-related incidents.Furthermore, I observed that the company's allergen testing procedures were not conducted regularly or consistently. This could result in undetected allergen contamination in the final products. I recommended that the company establish a regular testing schedule and ensurethat all necessary tests are conducted according toindustry standards. This would help to identify anypotential allergen issues and prevent them from reaching consumers.In conclusion, the food company's allergen management plan had a strong foundation but required some adjustmentsto enhance its effectiveness. By addressing the issues with ingredient labeling, employee training, and allergen testing, the company can better protect allergic consumers and maintain the safety of their products.中文回答：食品企业需要制定有效的过敏原管理计划，以确保产品的安全性，并保护食物过敏的消费者。

跟踪干预计划及措施英文回答：Tracking intervention plans and measures is crucial for effective project management. It helps to ensure that the project stays on track and achieves its objectives within the defined timeline and budget. In this response, I will discuss how I track intervention plans and measures in my project management role.Firstly, I create a detailed project plan that includes all the necessary interventions and measures. This plan serves as a roadmap for the project and outlines the specific actions that need to be taken to achieve the desired outcomes. I break down the plan into smaller tasks and assign responsibilities to team members. This ensures that everyone knows what needs to be done and who is responsible for each task.To track the progress of interventions, I use varioustools and techniques. One of the most effective methods is using a project management software, such as Microsoft Project or Trello. These tools allow me to create a visual representation of the project plan, set deadlines for each task, and track the progress in real-time. I can easily see if any interventions are falling behind schedule and take corrective actions accordingly.In addition to using project management software, I also hold regular team meetings to discuss the progress of interventions. During these meetings, team members provide updates on their tasks and any challenges they are facing. This allows me to identify any issues or roadblocks early on and take immediate action to resolve them. It also helps to keep everyone accountable and motivated to achieve their targets.Furthermore, I use key performance indicators (KPIs) to measure the effectiveness of interventions. For example, if the intervention is aimed at improving customer satisfaction, I would track the customer satisfaction score on a regular basis. This provides a clear picture ofwhether the intervention is achieving the desired resultsor if adjustments need to be made.To ensure the success of intervention plans and measures, it is important to regularly review and evaluate their effectiveness. I conduct post-implementation reviewsto assess the impact of interventions and identify areasfor improvement. This feedback loop allows me to continuously refine and optimize the intervention plans for better outcomes.Overall, tracking intervention plans and measures requires a combination of effective project planning, the use of project management tools, regular team communication, and performance measurement. By implementing these strategies, I can effectively monitor the progress of interventions and take timely actions to ensure project success.中文回答：跟踪干预计划及措施对于有效的项目管理至关重要。

产品清洁度管控方案及流程Product cleanliness control and management are critical aspects of ensuring the safety and quality of products. 产品清洁度管控和管理是确保产品安全和质量的关键方面。

To effectively manage and control product cleanliness, a comprehensive plan and process must be established. This begins with understanding the specific cleanliness requirements of the product and the standards that must be met. Effective communication with stakeholders, including production teams, quality control personnel, and suppliers, is essential to ensure that everyone is aligned with the cleanliness goals. This may include establishing cleanliness criteria, defining acceptable levels of cleanliness, and implementing inspection and testing procedures. 为有效地管理和控制产品的清洁度，必须建立全面的计划和流程。

首先要了解产品的具体清洁度要求和必须满足的标准。

与利益相关者进行有效沟通，包括生产团队、质量控制人员和供应商，是确保所有人与清洁度目标保持一致的关键。