Airborne particle deposition in cleanrooms: Calculation of product contamination and required cleanroom class
نویسندگان
چکیده
This is the third and final article in a series that discusses the deposition of airborne particles onto critical surfaces in cleanrooms. This article explains a method for calculating the amount of particle or microbe-carrying particle deposition onto critical cleanroom surfaces, such as product, and a method for calculating the airborne particle cleanliness class, or airborne microbial concentration that is required to obtain a specified and acceptable amount of product contamination.
منابع مشابه
Calculation of airborne cleanliness and air supply rate for non-unidirectional airflow cleanrooms
When designing a cleanroom to achieve a required airborne cleanliness standard or grade, such as specified in ISO 1464411 or the European Union Guidelines to Good Manufacturing Practice (EU GGMP)2, designers have difficulties deciding how much filtered air should be supplied to the cleanroom to achieve the correct airborne cleanliness requirement. Currently, this decision is based on experience...
متن کاملAirborne particle deposition in cleanrooms: Relationship between deposition rate and airborne concentration
This article is the second of a series that discusses the deposition of airborne particles onto cleanroom surfaces. It investigates the relationship between the airborne concentration of a range of cumulative sizes of particles and the particle deposition rate (PDR) onto cleanroom surfaces, through knowledge of the deposition velocity of particles in air. The deposition velocity of a range of c...
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Abstract: Background and aims: Nowadays, cleanrooms have become impartible parts of an industry with sensitive products. Sources of contamination in cleanrooms are impaired performance and quality sensitive products in the cleanrooms .The aim of this study was to evaluate the efficiency of HEPA filter and check the concentration and number of airborne particles in cleanrooms for pharmaceutic...
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When designing a cleanroom to achieve a required airborne cleanliness class or grade, such as specified in the International Organization for Standardization (ISO) 14644-11, or the European Union Guidelines to Good Manufacturing Practice (EU GGMP)2, designers have a problem in deciding how much filtered air should be supplied to the cleanroom. Currently, this is not normally calculated but base...
متن کاملCalculation of air supply rates and concentrations of airborne contamination in non- UDAF cleanrooms
W Whyte1, T Eaton2, WM Whyte1, N Lenegan3, S Ward4 and K Agricola5 1 School of Engineering, University of Glasgow, Glasgow G12 8QQ 2 AstraZeneca, Macclesfield, Cheshire, SK10 2NA 3 Energy and Carbon Reduction Solutions, Ashton-Under-Lyne, Lancashire, OL5 0RF 4 Validair, Wrotham, Kent, TN15 7RJ 5 Technology of Sense BV, Institutenweg 15, Enschede, 7521PH, the Netherlands Calculation of air suppl...
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