APCPPE (Assessing the Particulate Containment Performance of Pharmaceutical Equipment)

Guide to the uniform evaluation of containment systems, published in 2004 by ISPE.

What is APCPPE?

Importance for slide packages

Distinction from SMEPAC

01 What is APCPPE?

APCPPE, formerly SMEPAC, is a guide for the consistent evaluation of containment systems, published in 2004 by ISPE (the International Society for Pharmaceutical Engineering). The guidelines it contains are continuously evaluated and adjusted where necessary. In particular, containment systems should be validated in terms of their tightness and operational use.

02 Importance for slide packages

The film packages offered by Rhein-Plast are an essential component in meeting APCPPE guidelines. The specific requirements of each carrier system can be taken into account, and the most suitable containment solution identified.

03 Distinction from SMEPAC

APCPPE replaced the older SMEPAC standard. For current validations, supplier qualifications and regulatory submissions, only the ISPE APCPPE guide applies. Older documents that still refer to SMEPAC should be updated at the next revision.

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