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FW: Settle plate viable count specification - 4 hour exposure
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Hi Forum Re-sending Maureen _____________________________________________ From: Maureen Dennehy Sent: 11 January 2008 01:27 PM To: 'gmp@www2.pharmweb.net' Subject: Settle plate viable count specification - 4 hour exposure Dear Forum members The viable count specification for settle plates used in environmental monitoring of air Grades A-D is given in cfu/4hours. A footnote adds that “individual settle plates may be exposed for less than four hours”. I am seeking experienced advice on the following. Note that the debate triggering this query relates to monitoring in a biosafety cabinet, which is a Grade A environment, not in a production clean room. - Must the entire monitoring period be 4 hours or is it acceptable to leave the plate for two hours and decrease the specification proportionally? Alternatively, would two plates for two hours, with cumulative count, be defendable? - We are finding it extremely difficult to monitor during operation in the biosafety cabinet due to space limitations. Do others routinely do this in operation? If so, how many plates are used and for how long? Is monitoring also done at rest? Your inputs will be appreciated. Regards Maureen Dr Maureen Dennehy Quality Operations Manager The Biovac Institute 15 Alexandra Road, Pinelands, Cape Town P/Bag X3, Pinelands, 7430, South Africa Phone: +27-21-514 5000 / 514 5005 Cell: 082-307 6875 Fax: +27-21-511 3974/ 511 3962 Email: maureen@biovacinstitute.co.za _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ This email is confidential. Any unauthorised use or interception of this email by persons or entities other than the intended recipient is prohibited. If you are not the intended addressee or have mistakenly received this correspondence, please notify us immediately by reply email, and delete this email and any attached files.[TBICPT] |
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