gillian

Materials must be moved into and out of cleanrooms in a manner that reduces transfer of particulate contamination into the ISO classified suite. Sealed double door pass-through boxes are often used as a convenient and efficient means of transferring directly from the buffer room...

What's wrong with this picture? The HEPA filter is stained with overspray from the compounding operation.  While there are no tests that a certifier will conduct that tend to demonstrate that this staining is problematic, the FDA has made it clear through their...