The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More

On-Demand Webinars

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Video: The production process and qualification of film: A film manufacturer perspective

What is needed to qualify primary packaging materials for Large Volume Parenterals? And what to consider when selecting the right...

Cleaning, Disinfection and Sterilization of Medical Devices: Updates to Reprocessing Guidance Documents AAMI TIR 12 and TIR30 (ST98)

In the last few years reusable medical devices have gained the spotlight in the medical device industry and regulatory landscape....

Cytotoxic Reactivity: Understanding the Cause and the Path Forward

All medical devices intended to contact the patient are required to undergo a biological evaluation to demonstrate their safety. The...

After E&L: Updates to the Standard for Toxicological Risk Assessment 10993-17

Use of extractables and leachables (E&L) chemistry testing has become commonplace (and often essential) in medical device biocompatibility evaluations. The...

LVP polyolefin solutions addressing different packaging and regulatory requirements

LVP can be packed in different packaging formats made from polyolefins: pouches, bottles produced in blow-fill-seal process or Injection stretch...