Resources
Something to take to your team.
Datasheets, answers to common questions and plain guidance on methods and regulations, written for QA, validation and engineering teams.
Compliance guidance
The regulations, in plain words.
Compliance
EU GMP Annex 1 and IV bags
What 100% integrity testing means for bags closed by fusion.
Read the guideCompliance
Standards map
Annex 1, USP <1207>, Annex 11, Part 11, PIC/S and ICH Q9.
See the mapIn preparation
Application notes
Test data by bag format and condition, published as each is cleared.
In preparation
In preparation
Case studies
Projects with manufacturers, published with their approval.
In preparation
Send us your bags. We will show you the result.
A feasibility study on your own bag formats, with a written report your QA team can use.