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