CLEANROOM SOPs cover everything from gowning and hygiene to allowable materials and maintenance. An audit can ensure conformance to those standards. Conformance Auditing Basics This Technical Brief presents an overview of: Standard operating procedures (SOPs). SOP auditing benefits and limitations. Preparation and execution of a conformance audit. Cleanroom maintenance. Proper wiping techniques. Get briefed on all [Read More…]
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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…]