About the Sterile Products Processing (SPP) COP
The SPP COP core competencies are related to design, operation, maintenance, and qualification of sterile
manufacturing facilities and sterile manufacturing processes. The SPP COP is a primary influence and
contributor to the ISPE Sterile Manufacturing Baseline® Guide.
The SPP COP aims to establish and manage a forum that supports all facets of sterile products processing;
enables common interest discussions; provides access to relevant information; and supports member networking
How to Get Involved
As a SPP COP member you can access technical
discussions or download presentations or files. You
can complete a volunteer profile and share your expertise with the community.
Note that only ISPE Members can engage in these activities.
Continuous particle count
Sterile Products Processing, 7 November,
I would like just to check if I read well EU GMP Annex 1 and FDA Guide for steri ...
Acceptability of vial seal crimps
Sterile Products Processing, 1 November,
We close our vials and bottles with rubber stoppers secured with aluminum caps (seals). The caps ar ...
Sterile Products Processing, 29 October,
I have seen few facilities which are designed for sterile and OSD with common passage of class 10000 ...
analytical requirements for co-packed diluent
Sterile Products Processing, 28 October,
What are FDA/EMA requirements, if any, for analytical testing of incoming vialed diluent that the re ...
launching of sterile product
Sterile Products Processing, 26 October,
how to launch new product in new sterile facility:
Is it mandatory to perform media fill prior to s ...