A low endotoxin cleanroom wipe has a guaranteed endotoxin limit of <20 EU/device – <0.5 EU/mL. This is especially important when you read the FDA Guidance for Industry: Pyrogen and Endotoxins Testing. A 3rd party lab should perform the testing and the testing must be on a lot to lot basis. Printed documentation must be [Read More…]
Introduction Pharmaceutical and medical device manufacturing personnel must cope with endotoxins – a contamination source unique to their industries. Endotoxins, also known as pyrogens, originate from dead (!) gram negative bacteria. When this strain of bacteria are killed by antibacterial reagents (say phenolic or quaternary ammonium compounds), radiation, steam sterilization, etc. the cell wall detritus [Read More…]
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