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

Particle Testing Standards (2 posts)

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  • Avatar Image said 2 years, 3 months ago:

    Newbie here looking for information on particle testing protocol.

    How long should the particle counter sample time be?
    How many samplings should I take at the same location?

    Thanks in advance for your replies.

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  • Avatar Image said 2 years, 3 months ago:

    Refer to ISO14644-1 Annex B, the volume sampled at each location shall be at least 2 litres, with a minimum sampling time at each location of 1 min.

    Where only one sampling location is require, take a minimum of three single sample volumes at that location.

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