14._Cleanroom_design

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Hospital: Immuno-deficiency therapy, Isolation of contagious patients, Operating rooms
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Classification of Clean Rooms
• Clean rooms are classified by the cleanliness of their air. • The method most universally applied is the one suggested in versions of Federal Standard 209. • In this standard the number of particles equal to and greater than 0.5 um is measured in one cubic foot of air and this count is used to classify the room.
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Some App• Electronics: Computers, TV tubes, Flat screens, Magnetic tape production Semiconductors:Production of integrated circuits used in computer memory and control. Micro-mechanics Gyroscopes, Miniature bearings, Compact disc players Optics: Lenses, Photographic film, Laser equipment Biotechnology: Antibiotic production, Genetic engineering Pharmacy: Sterile pharmaceuticals Heart valves, Cardiac by-pass systems Disease-free food and drink • Medical devices: Food and drink: • •


3 500 000 20 000 not defined (c)not defined(c)
3 500 000 20 000

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Classification of Clean Rooms
• • • • • • • • Grade A C D Grade A C D Examples of Operations for Terminally Sterilized Products Filling of products, when unusually at risk Preparation of solutions, when unusually at risk. Filling of products Preparation of solutions and components for subsequent filling Examples of Operations for Aseptic Preparations Aseptic preparation and filling Preparation of solutions to be filtered Handling of components after washing. • • • • • • • •
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Classification of Clean Rooms
• The above equation was chosen so that the class limits set by the Federal Standard at its standard reference point of 0.5µm coincide closely with those found in the ISO standard. This allows a harmonious transition from the previous clean room standards. It should be noted that there is a crossover to the Federal Standard 209 classes. If the particle concentration/m³ in the ISO standard is divided by 35.2 the count is converted to counts/ft³ . The equivalent Federal Standard 209 classification is then found at the 0.5 um size, e.g. an ISO Class 5 is equivalent to Federal Standard 209 Class 100. A comparison in given in table 3. • • • • • •
Clean Rooms
Clean-rooms; A modern industrial phenomenon
• The requirement for clean rooms can be broadly divided into two.
– The first area is that in which inanimate particles (dust) are a problem and where their presence, even in sub-micron size, may prevent a product functioning or reduce its useful life. – The second group requires the absence of microbe-carrying particles whose growth in the product could lead to human infection.
What is a Clean Room?
A clean room now has a special meaning as Defined in Federal Standard 209E as: 'A room in which the concentration of airborne particles is controlled and which contains one or more clean zones.’ and in ISO 14644-1: 'A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the room and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary.'
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Classification of Clean Rooms
• • • • • • • • • A B(a) C(a) D(a) Notes Airborne classifications in the EU Maximum permitted number of particles/m³ equal to or above Grade at rest (b) 0.5 um 3 500 3 500 350 000 5 um 0 0 2 000 in operation 0.5 um 3 500 350 000 5 um 0 2 000

FS 209 (US STANDARD) Classes Class 1 Class 10 Class 100 Class 1000 Class 10000 Class 100000
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Classification of Clean Rooms
• the airborne particle concentration of a clean room is dependent on the particle generating activities going on in the room. If a room is empty, a very low particle concentration can be achieved, this closely reflecting the quality of air supplied. If the room has production equipment in it that is operating, there should be a greater particle concentration, but the greatest concentration occurs when the room is in full production. The classification of the room may therefore be carried out in these different occupancy states.
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Classification of Clean Rooms
• The specification as per Federal Standard 209 for other particle sizes is as follows:
• • • • • • • • Table 1 Federal Standard 209 class limits Class 1 10 100 1,000 10,000 100,000 Particles / ft³ 0.1 mm 0.2 mm 0.3 um 0.5 mm 35 350 NA NA NA NA 7.5 75 750 NA NA NA 3 30 300 NA NA NA 1 10 100 1,000 10,000 100,000 5.0 mm NA NA NA 7 70 700