Compliance
EU GMP Annex 1 and IV bags
The 2022 revision of Annex 1 changed what regulators expect from manufacturers of sterile products. For IV bags, it makes integrity testing of every unit the reference point.
What the text says
Every bag closed by fusion.
Annex 1 asks that containers closed by fusion, which includes the welded seals and ports of plastic IV bags, are subject to 100% integrity testing. Samples of other container types are checked using appropriate methods.
It also expects the integrity test method to be validated, and the container closure system to be shown to protect the product throughout its shelf life.
Paraphrased from EU GMP Annex 1 (2022), section 8.22 and related clauses. Check against the official text before relying on it.
What it means for IV bags
From sampling to every unit.
For many plants this is a change of approach, not just of equipment.
- 01
Every bag
A sampling plan alone is no longer enough for bags closed by fusion. Every unit needs an integrity result.
- 02
A suitable method
The method must work on flexible bags in their real condition, and be validated for your formats.
- 03
Data you can show
Inspectors will ask how each result was obtained, stored and reviewed, which brings Annex 11 into scope.
How ASTRACEC maps to it
100% testing at line speed, without losing a bag.
VEGA tests every bag on the filling line, up to 8 000 bags per hour. POLAR supports method development, batch release and investigations in the laboratory with the same method.
- Non-destructive: tested bags go on to release
- Deterministic, quantitative result for every bag
- Works on wet, autoclaved and over-wrapped bags
- Data recording designed for EU GMP Annex 11 (audit trail and user management to be confirmed per configuration)
Preparing for Annex 1 on your bag lines?
Start with a feasibility study on your own formats, and a written report you can add to your validation file.