Concerned about how Annex 1 might affect you?
Industry experts answer over 40 common Annex 1 draft questions including:
- During cleanroom classification, is it mandatory to monitor viable and non-viable counts simultaneously?
- Can you choose not to use one of the microbiological sampling methods for qualification of a classified area?
- Does the removal of the 5 micron particle size from ISO 14644 mean the qualification time for Grade A and B will be vastly reduced?
- Have particle sizes greater than 5.0 been removed as a requirement of Grade A or B monitoring?
Get answers to these and other questions by filling out the form and downloading the paper. If you can’t find the answer to your question, the contact information for an Annex 1 expert is included at the end of the paper.
Get started now on meeting the new EU GMP Annex 1. Particle Measuring Systems can help you with: