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Containment & Rapid Microbiological Methods
SGVC / GSIA Joint Hybrid Workshop Q2 - 2023
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1.
Which containment issues should we cover?
(Required.)
Secondary Containment (Clean Room Design & Project Life Cycle)
Secondary Containment (Rigid Containment Solutions)
Secondary Containment (Flexible Containment Solutions such as Single Use Systems or Retrofit)
Revamping Clean Rooms
Other:
2.
Primary Containment
Isolator Aseptic Process
Isolator Process with cytotoxic API
Isolator Process aspetic and toxic
Rabs Open / Closed
3.
Specific Isolator Topics
Initial Qualification & Requalification incl. Calibration
Residual Peroxyde Level and Sterility Tests
Elimination of Oxygen - Anaerobic Chambers and Isolators
4.
RMM (Rapid Microbiological Methods) for bioburden monitoring
Air as a Medium (air monitoring)
Water as a Medium (water monitoring)
Personnel monitoring
Any other monitoring ?
Regulatory issues
Current Progress,
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