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.
monitoring for aseptic dispensing facilities” [1] with section 1 covering physical test methods and section 2 covering microbiological test methods. It is recommended that monitoring performed should be at least at the minimum specified frequencies in order to provide t he necessary information.
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