Monitoring Support

Monitoring Support

Establishing a valid and comprehensive Environmental Monitoring Plan that takes into account required Micro Testing, Water Testing, Product Bioburden and Endotoxin Testing is crucial for your Cleanroom and its products.

We have supported a number of clients with a range of Monitoring Support activities including:

Monitoring Support
  • ISO 14698 is the recommended guideline for Environmental Monitoring which entails examining each the following areas:Writing and updating current Environmental Monitoring Policies and Procedures.
  • Establishing new Environmental Monitoring Plans.
  • Maintaining and supporting existing plans.
  • Performing Risk Assessments on the Environmental Monitoring Process.
  • Supporting investigations on out of spec results.
  • Choice of Microbiological Sampling
  • Sampling Locations
  • Sampling Map
  • Sampling Frequency
  • Establishing Alert & Action Limits
  • Interpretation of Results
  • Out of Spec Results
  • Performing Investigations
  • Maintaining a library of Organisms
  • Reporting Trending & Documentation Systems

The same type of plan can be put in place for Water Testing requirements, Product Bioburden and Product Endotoxin Testing.