Bulletin Board

New Sterile Guide Released!
The newly updated ISPE Baseline® Guide: Sterile Product Manufacturing Facilities contains recommendations to help facilitate compliance with the latest FDA and EMA guidance. Read more.

 

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. 

Download the SPP COP brochure ( 162 KB).

 

COP Mission

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 opportunities. 

 

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.

 

Community Discussions

  • Bioburden testing before First Filtration for Liquid Sterile Products
    Sterile Products Processing, 3 May, (3 comments)
    I am interested in knowing the best practice for ensuring sterility of liquid biologic products (no ... Continue reading
  • Sanitization of Ceiling in the A space
    Sterile Products Processing, 18 April, (5 comments)
    I would like to hear what others are doing for sanitization of the ceiling in the A space. The ceili ... Continue reading
  • Annex 1 Containers sealed under vacuum
    Sterile Products Processing, 12 April, (2 comments)
    Per section 123, Containers sealed under vacuum should be tested for maintenance of that vacuum afte ... Continue reading
  • Intepretation of microbiological monitoring guidelines
    Sterile Products Processing, 28 March, (3 comments)
    Is it mandatory to perform both, the active air monitoring (centrifugal for example) and pasive air ... Continue reading
  • WFI in bulk vs WFI in containers
    Sterile Products Processing, 22 March, (5 comments)
    Hi, I work in a small pharmaceutical company developing a sterile vaccine. We do have clean rooms a ... Continue reading