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: Knowledge Base
20
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…]
15
Aug
Aug
CAPSURE® IS A BREAKTHROUGH technology from Berkshire Corporation. Its innovative process enables wipers to capture and retain more contaminant particles and, therefore, provide a more effective wipe with reduced risk of recontamination. Video Demonstration In the video below, we demonstrate the particle-retention performance of CapSure®: CapSure® Products Online Berkshire incorporates the CapSure® technology into several [Read More…]
