Transcription of GUIDELINES ON TEST METHODS FOR ENVIRONMENTAL …
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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 being on or over the action level197. Use of settle plates208. Determination of airborne microbiological contamination by active air sampling239.
the working activity (typically at bench height 1m from the floor). A site plan should be prepared indicati ng sampling locations. The minimum volume to be sampled is 27L (approx 1ft³). The sampling rate can vary but most particle counters operate at …
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