Pharma and Biotech manufacturing facilities face ever more demanding regulatory and productivity challenges. These challenges are made more acute as products come off patent protection.
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For pharmaceuticals that cannot be given terminal sterilization at the end of production, the alternative of aseptic fill is available, requiring sterile materials placed in sterile containers in a cleanroom.
Thorough cleaning is crucial to aseptic fill operations, but it must be validated as well as monitored. This article has presented some sampling, extraction and analysis options that have proved successful in their application.
During the manufacture of pharmaceutical and biotechnology products, care must be taken to ensure that these products are not contaminated either by the previous manufacturing run or by the cleaning process itself.