Environmental Monitoring Supports a Risk-Based Approach to Manufacturing Control

Posted by Richard Nardini, Environmental Services Manager on December 04, 2018

Robust Environmental Monitoring Program includes information to support process controls through sample collection, microbial testing and trending data. 

Environmental monitoring is one way a device manufacturer demonstrates control within a production area. Environmental samples from water, air and surfaces support verification of process controls and ultimately support product safety. Trending this valuable data offers manufacturers a qualitative indicator of the cleanliness and controls within their production areas.

Where manufacturing operators and technicians are present, some level of microbial contamination is inevitable, which is why it is important to consider environmental monitoring as a critical process. WuXi AppTec’s microorganism environmental monitoring process supports the detection and enumeration of bacteria, yeast and mold, and includes the monitoring of production area personnel, air and surfaces for the presence of microbial contamination.

Executing a well-developed risk-based environmental monitoring plan:

  • Construct sampling and collection procedures
  • Identify sample sites
  • Define sampling number, interval and frequency
  • Demonstrate a consistent and reproducible level of quality control
  • Provide guidance on follow-up activities where organisms are present
  • Support preventive measures to avoid future contamination pitfalls by keeping organizations well informed

WuXi AppTec’s Environmental Monitoring Program supports customers’ objectives by providing exceptional testing in tandem with timely and accurate results. Our scalability supports small to large facilities as well as overflow collection situations. Our ability to adapt allows us to support complex testing needs when unexpected events occur.

To learn more about how we work with you and your team to satisfy your environmental monitoring needs for manufacturing control, contact us.

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Topics: Medical Device, Technical Expertise, Microbiology