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Explore microbial air sampling solutions to meet EC GMP, ISO 14698-1, USP 797, and FDA Sterile Guidelines (2004). This presentation covers validation requirements. |
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Click here to signup and download files ( Microbial Monitoring of Compressed Gas Lines) There is a need to monitor for particulates and microbial contaminants in pharmaceutical gas lines, whether they are used as a process gas, control gas with open vent into the clean room, or as an aspiration point within a process. The regulations state that all processes shall meet either defined limits as set in the ruling or guidance document or follow appropriate ISO standard. |
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