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GUIDELINES ON TEST METHODS FOR ENVIRONMENTAL …

GUIDELINES ON TEST METHODS FOR ENVIRONMENTAL MONITORING FOR ASEPTIC DISPENSING FACILITIESPRODUCED BYA WORKING GROUP OF THE SCOTTISH QUALITY ASSURANCE SPECIALIST INTEREST GROUP SECOND EDITION FEBRUARY 2004 1 ContentsPage NumberGeneral Introduction2 Test Methodologies3 Section 1- Physical Tests4 Introduction41. Non-viable particle counts52. Pressure differentials93. Airflow velocity114. Air change rate135. Operator protection factor156. Filter Integrity Testing16 Section 2 - Microbiological Tests17 Introduction17 General Information- Sample equipment 17- Sampling conditions17- Sample locations18- Incubation conditions18- Results and reading of samples18- Action levels19- Action to be taken in the event of a result

during routine operator or process simulation tests, in order not to compromise the q uality of any products prepared that may be administered to patients. Testing in the at rest state can be carried out to monitor baseline contamination levels. Surfaces and personnel should also be monitored at the frequencies stated. A report of the

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