Global
TO BE USED in a sterile environment, production consumables, like wipers, must conform to high standards and be documented as validated sterile. Meeting Manufacturing & Documentation Standards This Technical Brief presents an overview of: The concept of sterility. Good Manufacturing Practices (cGMPs). Validated procedures for sterile manufacturing. ANSI / AAMI / ISO standards for sterility. Sterility [Read More…]
Category Archives: Aseptic Cleaning
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Aug
Aug
HERE’S A LOOK at the types of contaminants that can be found on medical devices during manufacturing and the optimal methods for removing them. Particle Contamination & Removal Techniques This Technical Brief presents an overview of: Contamination control concerns in medical device manufacturing scenarios. Optimal contaminant removal techniques. FDA trends and guidelines. In addition, frequently asked [Read More…]
