May 19, 2012

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Cleanroom Standards

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USP 797, BioPharmaceutical, EUGGMP, I.E.S.T., I.S.O., ASTM F1670, ASTM F1671, Federal, Pharmaceutical, FDA

what is the standard for Biohazard safety cabinet? (3 posts)

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  • Avatar Image said 2 years, 3 months ago:

    HI,

    I would like to know what is the MOST LATEST standard for Biosafety Cabinet and also "Laminar flow cleanbench (that is not BSC)".

    I saw there are some of the international standards applicable to Biohazard Cabinet including:
    -DIN 12950
    -NSF Std. 49
    -BS 5726
    -AS 2252 Pt. I (Class I)
    -AS 2252 Pt. II (Class II)
    -AS 2567 – Cytoxic Drug Safety Cabinet
    -US Fed. Std 209c, Class10

    However, I am about to start studying over about BSC and Laminar Flow validation and that seems a lot for me. Would anyone please educate me which is the most up-to-date and practical standard I need to go over first?

    Thank you so much.

  • Avatar Image said 2 years, 3 months ago:

    NSF-49 is the proper accreditation needed to certify Biological Safety Cabinets in the US

    IEST-RP-CC-006.3; Is used for the certification of Laminar Flow Devices

    ISO 14644 is the standard used for solid particle testing to meet ISO 5 classification of the environment

    Fed Standard 209E was replaced several years ago by ISO 14644

  • Avatar Image said 2 years, 3 months ago:

    Thank you for the reply. Here's what i understand.

    1. NSF-49 (US Standard) is only for BSC Class II
    2. EN 12469 (Standard from Europe comparable to NSF) is for all class I,II,III of BSC
    3. AS1396.5 is the Australian Standard for Laminar Flow Cabinets (horizontal, vertical flow cabinet)
    4. IEST-RP-CC-006.3 is also for Laminar Flow Cabinets

    Please correct me if there is anything incorrect.

    So if I want to go over for BSC and Laminar Flow Cabinets Validation what is your suggestion?

    Thanks

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