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Updated Air Monitoring Requirements for Medical Device Manufacturers

Uncontrolled particulates can become a problem for product quality if they permeate sensitive areas such as powder-coat lines or electronic components – a particular problem for medical devices that require a high degree of precision and are subject to U.S. Food and Drug Administration inspection.

The EU GMP Annex 1 provides specific guidance on the manufacture of sterile medicinal products. Though it is a European guide for manufacturing, EU GMP Annex 1’s impact is global. So how does the latest revision affect you?

Download this whitepaper to learn more about:

  • The importance of a contamination control strategy 
  • What classifies as an appropriate cleanroom 
  • Continuous monitoring via volumetric air sampling 

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