Your environmental monitoring (EM) program must demonstrate control over both viable and non-viable particles found in critical areas of your operation. The procedures and protocols you have in place must ensure asepticism throughout your operation.
With the new draft revision of EU GMP Annex 1 demonstrating the highest standards in patient safety, all healthcare businesses, that make use of cleanrooms in their manufacturing and production activities, are paying fresh attention to their environmental monitoring policies. This draft revision is also considered a big step towards creating a recognised global standard for the maintenance of cleanroom environments; hence the level of detail.
As the pharmaceutical community takes on board the sheer scale of