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