Cleanroom Blog

Welcome to our cleanroom blog where we keep you informed on recent updates in our business and cleanroom industry insights and updates. 

Fast Tracking a COVID-19 Vaccine

Fast Tracking a COVID-19 Vaccine

As our nation’s top scientists work tirelessly to develop a COVID-19 vaccine, the federal government, R&D groups and the pharmaceutical industry are working collaboratively to ensure our supply chain is ready to scale up production to meet the tremendous demand. Creating billions of doses of a COVID-19 vaccine is a herculean task.

A Risk-Based Approach for Biocompatibility

A Risk-Based Approach for Biocompatibility

The updated standard highlights that particular attention will be focused on the device materials used, rationale for biocompatibility tests performed, the compatibility of these materials with biological tissues, and the impact of the manufacturing processes on the material properties.

EU MDR Compliance

EU MDR Compliance

Gearing Up for EU MDR How cleanroom bioburden information can support biocompatibility assessments In medical device manufacturing, low bioburden levels are essential. We address EU MDR compliance from a bioburden and biocompatibility perspective for sterile medical...