JETT-AutoclaveURS

U SER R EQUIREMENTS T EMPLATE for a S ATURATED S TEAM A UTOCLAVE

NOTES for use of the User Requirements Template:

Upon completion of the template, delete this page prior to updating the Table of Contents and printing.

1.Many areas of this template have selections or tables that have been prepared

for guidance and ease of template completion. Text in italics is intended to be

used as notes to the User and should be deleted prior to printing. Any options

and/or examples that are not applicable to the specific document being created

should be deleted as well.

2.To update the final Table of Contents, place the cursor inside the shaded area,

press the Right mouse key, and select Update Field.

3.Items that can be directly tested are identified with a .

4.Where possible, the User should identify the source (e.g. studies, standards, etc.)

for the acceptable ranges of variables or other critical requirements that have

been derived.

REVISION HISTORY

T ABLE OF C ONTENTS

1.0INTRODUCTION (5)

2.0OVERVIEW (6)

3.0OPERATIONAL REQUIREMENTS (7)

3.1C APACITY (7)

3.2P ROCESS R EQUIREMENTS (7)

3.3P ROCESS C ONTROL (8)

3.4F UNCTIONS (8)

3.5D ATA AND S ECURITY (12)

3.6E NVIRONMENT (14)

4.0CONSTRAINTS (17)

4.1M ILESTONES AND T IMELINES (17)

4.2E QUIPMENT C ONSTRAINTS (18)

4.3C OMPATIBILITY AND S UPPORT (18)

4.4A VAILABILITY (21)

4.5P ROCEDURAL C ONSTRAINTS (21)

4.6M AINTENANCE (22)

5.0LIFE-CYCLE (23)

5.1D EVELOPMENT (23)

5.2T ESTING (23)

5.3D ELIVERY (24)

5.4S UPPORT (25)

6.0GLOSSARY (26)

7.0REFERENCES (27)

8.0APPROVAL (28)

Project No.:

Insert the unique project number associated with this particular URS.

Document No.:

Insert the Document Identification Number and Revision.

Document Description:

Insert description of document, e.g. Saturated Steam Autoclave for Sterile Manufacturing Support.

1.0INTRODUCTION

Note: Insert your own description and introduction. You may wish to include your own requirements and specifics to allow the inexperienced reader,

contractors, and suppliers adequate explanation to understand the scope of the equipment.

Describe who produced the document, under what authority, and for what

purpose.

Describe the contractual status of the document. Include or reference as an

attachment the “legal” paragraph that communicates purchasing terms and

conditions in this section.

Describe the relationship of this document to other documents. This is

important for equipment that is part of an integrated process or line and will

help the Supplier to understand and ask questions that may otherwise be

overlooked.

Refer to the Equipment Validation Plan that outlines the Supplier’s

responsibilities is attached.

Remove any options that are not applicable for this project, if other uses will

apply list each separately.

This is to be utilized as a guide for the user to answer the majority of questions involved in specifying the “what” for the equipment. Addendums may be used to round out the requirements.

2.0OVERVIEW

This document encompasses the normal range of equipment operations. This

section should be expanded to provide a high level description of the system

explaining why it is required and what is required of it. Include the background, key objectives, and the main functions and interfaces. Obviously, technology

improvements and new applications may require deviation from this template.

The User should consider including information on the following:

?Use: Describe what applications the equipment/system will be used to support. Include a brief explanation of the general functions.

?For example: The autoclave will use saturated steam to sterilize product contact and critical equipment used in the aseptic formulation and filling

of parenteral drugs. Capacity and/or Critical Attributes: Provide a brief

description of the equipment/system capacity or throughput

requirements or the critical attributes that make it desirable to acquire

the system. (Also reference any industry standards for the autoclave that

are applicable.)

For example: Provide actual chamber size needed or number of specific

components to properly size the chamber.

For example: The system must provide, at minimum, the following basic

cycles:

:

Vented Saturated Steam Cycle

1)Heating Phase

2)Exposure Phase

3)Cooling Phase

Forced Air Removal Cycle

1)Air Removal Phase

2)Heating Phase

3)Exposure Phase

4)Exhaust Phase

5)Vacuum Drying Phase

6)Vacuum Relief Phase

3.0OPERATIONAL REQUIREMENTS

3.1Capacity

?Describe the range or list specifically the materials, products or

equipment to be sterilized.

-Materials

-Products

-Liquids – Vented or Non-Vented

?Size of loads.

For example for materials: lab glassware, plastic tubing, liquids in

sealed glass containers, and liquids in sealed plastic containers.

3.2Process Requirements

Describe the number of doors and loading and unloading requirements for

the autoclave. Define if the equipment will be floor or pit mounted and

how this will impact the loading requirements.

Describe in detail the requirements for the various steps/phases that are

required. In each phase identify the critical control requirements and

variables that are needed. For example:

?Air Removal Phase (if required)

-Range of vacuum (or gravity only)

-Number of vacuum pulses.

-Time to attain vacuum

-Range of vacuum hold time.

-Vacuum level

For the following phases also provide critical control requirements and variables:

?Charge Phase

?Exposure Phase

?Exhaust Phase

?Drying Phase (if required)

?Vacuum Relief Phase (if required)

Define door seal medium (e.g. clean steam or pharmaceutical air)

requirements. Define if backup door sealing is required.

3.3Ancillary Equipment

Describe ancillary supplied equipment; for example, loading carts/transfer carriage requirements.

3.4Process Control

Identify the critical process measurements such as temperature and

pressure. For each critical measurement or control device list the:

?Measurement Range

?Setpoint Range

?Parameter Control Tolerance

If you desire special monitoring such as monitoring at specific

locations in the chamber or piping or redundant process

measurements include it in this list (for example include chamber

drain, chamber load probe (and number of probes required), chart

recorder probe). If there are standardized tests you want the supplier

to run that have given tolerances (e.g. European Norm 285) list the

applicable tests. If you are unsure what the supplier provides in their

standard models, have them provide that information to you in their

request for submittal.

Note: At a minimum, list the critical, process parameters. Consider

documenting how/where each of the parameter requirements was

determined.

3.5Functions

3.5.1Operation

Enter your specific operational requirements here.

?Basic configurable cycles or phases required.

?Number of Cycles

?Recipe capabilities. (Linking of cycles or phases sequentially) Consider providing a recipe that the system must be capable

of running.

?Operator interaction with the system. Describe your

expectations for keyboard, mouse or touch screen interaction.

The following are examples: The system shall be able to run the

multiphase cycle from start to finish with no operator interaction

required after the cycle is properly initiated.

The system shall be operated locally at the autoclave.

Describe the control system requirements in terms of manual,

semi-automatic and automatic operation. Be as specific as possible on “what” the system should do.

3.5.2Power failure/Recovery

Power Failure: Insert your specific power failure/recovery scheme

here.

For example:

In the event of a power failure, the system shall protect in the

following priority:

?Personnel

?Equipment

?Product

In the event of a power failure the autoclave controls shall

mechanically fail to a state that places the chamber in a vented

state at atmospheric pressure.

Recovery Methods: Insert your specific power failure recovery

scheme here.

For example:

?Manually re-start based on operator inputs (Operator initiates power recovery sequence).

?Re-start based on last state before loss of power. (System runs through power recovery sequence when operator start

signal is given)

?If there is an automatic batch reporting system, the

information shall be retained in the event of a power failure

(A UPS is required for automatic batch reporting systems for

data retention).

Abort or resume cycle based on length of power failure or temperature deviation from setpoint.

3.5.3“Emergency Stop”

Insert your specific “Emergency Stop” (E-Stop) strategy and

communication scheme here.

For example:The system shall have an E-Stop mechanism

designed to stop all physical movement of the equipment

immediately. The E-Stop mechanism(s) shall be located in close

proximity to the autoclave loading and unloading doors.

3.5.4“Operator Abort”

Describe the requirements for the system response to an operator

initiated cycle abort. Describe the final state the autoclave needs to be in at the conclusion of the abort sequence.

3.5.5Alarms and Warnings

“Critical alarms” - Insert your specific “Critical Alarm” action

scheme here.

For example: Critical Alarms shall take action automatically to

shut the equipment down and notify the operator of the

condition(s). The operator shall be required to acknowledge the

alarm before the alarm can be reset and the system restarted. Once

the alarm is reset, the operator may restart the system.

Note: For a customized equipment application, include an alarm

table, like the example that follows.

For example:

The Equipment shall have the following critical alarms and

warnings:

The list of critical alarms in the table is not intended to be a

comprehensive list of all alarms for the system. A complete alarm

list will be developed and included in the Functional Specification

document.

For a standard equipment type application, request the supplier to

submit the complete alarm list and differentiate between critical

and informational alarms.

Note: Consider documenting how “critical and non-critical”

criteria were determined.

3.5.6Informational Messages

“Informational Messages” shall notify the operator and take no

further action.

3.5.7Interlocks

Define the interlocks that are to be supplied with the system. For

example:

?The cycle cannot be initiated until the jacket temperature is

above 100?C.

?The cycle cannot be initiated until the door(s) is closed and

locked.

?The cycle cannot be initiated unless adequate steam, air and

water pressure are available.

?There are no active alarms.

3.6Data and Security

Controls provided with Electronic Data Collection intended for use in the manufacture of pharmaceutical products shall be required to comply with

21 CFR Part 11 . The supplier shall stipulate the methods by which this

criterion is met. It is helpful to be specific here.

Security for data and operator access is provided by (User ID/Password, Card Reader, Biometric (Fingerprint, eye scan, voice recognition, etc.),

etc.).

3.6.1User Interfaces

This section should address the following issue:

?Operator interface access levels

Access to all Input/Output values and system status bits shall

be provided through a data-communication link.

3.6.2User Interface with Supervisors and Operators

Insert your interface scheme here. For example:

The CONTROL PLATFORM system shall include interfaces with

the Operator and Supervisor that ensures easy, safe, and reliable

operation.

An operator-interface panel shall be provided and mounted near

the equipment or on the equipment. This panel shall provide the

necessary switches, indicators, and devices to operate the

equipment.

3.6.2.1Language requirements

Specify language in which information will be displayed

(i.e. English, Spanish, German, Bilingual, etc.)

3.6.2.2Displayed Requirements:

State the system of measurement that will be used

(English or Metric (S.I.)).

3.6.3Security Levels

List the total number of different access levels that will be required.

Provide a general description of the access rights for each level

(screen navigation, operational control, control loop variable

manipulation, alarm setpoint manipulation, etc.).

3.6.4Interface with Other Equipment

The control system shall include the interfaces necessary to

facilitate operation and configuration. For example:

?An RS-232 communications port shall be provided.

? A Modem communications port shall be provided.

? A high-speed configuration/monitoring connection

shall be provided.

3.6.5Data Collection

Consider any archiving and reporting requirements here.

?None

?Recorder

?Process Printout

?Electronic process printout, Historical Trending

?Electronic process printout, Historical Trending and interface to company network

Define the list of process variables to be recorded and frequency of

recording. For example:

?Chamber Temperature

?Chamber Pressure

?Jacket Temperature

?Run Time

?If the system provides a report, define the expectations for

information to be included in the report

?Recipe ID

?Critical Recipe Parameters

?Batch Number

?Operator ID

?Date / Time of cycle start

?Alarms

?Sterilizer ID#

?Time, Pressure, and Temperature at:

?End of each vacuum

?End of each pressure pulse

?Start of plateau period

?End of plateau period

?Start of drying period

?End of drying period

3.7Environment

Provide details of the physical environment in which the

[equipment/system] will be operated. Also note the maximum height,

width and depth that the equipment can be to fit through doorways from

the point where the equipment enters the building to the point of

installation.

3.7.1Layout

For example: Allocated floor space for the equipment is _____

inches by ________ inches with at least a _______inch corridor

around the periphery for the equipment.

?Vertical clearance is _________ inches.

?See attached drawing #________________________ (if applicable).

?Floor or pit mounted

?Cabinet mounted

?Recessed in 1 or 2 walls

?Door type: hinged, vertical or horizontal sliding

?Bio-seal requirements

Layout is specific to the size equipment being used and system

requirements of the equipment.

Maximum allowable: Height

Length

Depth

Weight

Floor Load

3.7.2Physical Conditions

?Room Explosion Classification

List the critical explosion requirements for the room.

Room will be non-hazardous

Room will be Class I Div II (Zone 2) (explosive

atmosphere present at known times)

Room will be Class I Div I (Zone 1) (explosive

atmosphere present at all times)

?Environmental Classification

List the critical air quality requirements for the environment.

Class 100, 10,000, or 100,000 (Federal Standard 209E)

ISO Class 5, 7, or 8 (ISO 14644-1 and ISO 14644-2)

Class A, B, C, or D (The Rules Governing Medicinal

Products in the European Union – Annex 1)

Directional airflow

Airflow velocity

Number of air changes

Particle Ingress

?Biohazard Level

List the critical biohazard level requirements for the

environment.

BL-1

BL-2

BL-3

BL-4

?Rating of enclosures

List the rating requirements for enclosures in the environment.

NEMA 1 (Open)

NEMA 12 (Oil tight)

NEMA (Wash down)

NEMA 4X (Washdown and non-Corrosive)

3.7.3Cleaning Requirements

?Hand-Wash

?Auto-Wash

?Sanitization

?Steam Clean

3.7.4Intended Operating Environment:

Describe the type of operating environment that the

[equipment/system] will be exposed to following installation.

For example: The [equipment/system] shall be mounted in a GMP

environment with a temperature range of 15 to 25 °C, non-

condensing humidity.

Vibration levels in operating environment are

or Severe>

The Seismic Zone in the operating environment is .

4.0CONSTRAINTS

4.1Milestones and Timelines

Use one of the two schedule outlines provided below. Delete the schedule

not selected for use. Fill in time scales or dates as appropriate and

add/delete items as applicable. If available, refer to the user’s project

schedule to assist with this area. An agreed upon timeline may be

referenced here and attached as an appendix.

The parties involved should submit a basic timeline as outlined below:

4.2Equipment Constraints

Describe the operating constraints that the [equipment/system] will be

required to meet.

For example:

4.2.1Environmental Conditions

The [equipment/system] is to be used at the following

environmental conditions:

Altitude ________ ft above sea level

4.2.2Equipment Generated Vibration

The maximum allowable equipment vibration generated during

operation is .

4.3Compatibility and Support

Include any requirements for compatibility with other User systems. In

the examples provided below, fill in blanks with the appropriate

information. Delete areas that are not applicable to this application.

4.3.1CONTROL PLATFORM Controllers

The Supplier shall utilize Control Platform

Controllers that shall include a communications port.

The Supplier shall provide documentation that the program

(embedded software) was developed and coded utilizing

program development and documentation software.

The supplier shall indicate the use of custom or “bespoke” code

within the equipment, and shall supply licensing of the custom

code for the life of the equipment.

An escrow agreement shall be required in the event the supplier

cannot support the supplied custom software any longer. In such

instances, the source code and all information regarding the source

code shall be given to the user in a timely fashion to prevent

downtime of the equipment.

4.3.2Preferred Vendor List

If necessary the user may attach a Preferred Manufacturers List of

critical components. Refrain from driving the supplier into

customizing their equipment for your company. If the supplier

wishes to deviate from the Preferred Manufacturers List, a listing

of the proposed components and instrumentation manufacturers

indicating type and model numbers shall be submitted with the

quotation, along with an explanation of why the deviation is

recommended.

4.3.3Utilities

The utilities and space involved needs to be discussed prior to

purchasing the equipment. Obviously, the actual equipment size is

but a small part of the entire scope of work necessary to implement

a larger system. The unit and its support equipment must be able to

be installed in current building facilities.

The User shall ensure that the following utilities are available and

that the utility supply lines and piping are terminated with fittings

or connections, which are compatible with those described on the

Customer Connection Drawings.

The Supplier shall specify utility data, which is marked with a

triangle or code of some type (number code). Utility data, which

are not specified or marked with a triangle or code, shall be

brought to the attention of the User. These data shall be specified

(by the User or the Supplier) and shall be approved by both the

User and the Supplier before system design begins.

Base Utilities Worksheet

?Related Discharges

?Volume

?PH

?Temperature

?Materials

?User should indicate the maximum or minimum

volume, pH, temperature, etc. of discharges

?Electricity

?______ VAC ____ Hertz

?Phases

?Amperage

?Uninterruptible Power Supply (Define Use)

?Control Air

?Pressure

For example:

_______ PSIG (must be clean, dry ISA instrument

quality air, capacity to be determined by size of

equipment). Recommend at least 90 PSIG

constant air pressure for all equipment, unless

specified.

?Clean/Pure Steam (also must specify if pure or clean

steam is to be used. Further, detail if plant steam to be

used in jacket and then add plant steam requirements if

appropriate.

?Pressure in chamber

For example:

_______ PSIG

_______ Volume (peak and average)

?Pressure in jacket

For example:

_______ PSIG

_______ Volume (peak and average)

?Other Utility Requirements

Provide details regarding any other utility systems that are required to support operation of the equipment/system (e.g