Compliance
Standards map
The main regulations and guidance that apply to container closure integrity for IV bags, in one view, with what each means for your machine and your validation file.
At a glance
What each framework asks, and where ASTRACEC fits.
| Framework | Applies in | What it asks | How ASTRACEC supports it |
|---|---|---|---|
| EU GMP Annex 1 (2022) | Europe; adopted by PIC/S members | 100% integrity testing of containers closed by fusion; validated methods | VEGA tests every bag in-line; POLAR supports method development and release |
| USP <1207> | United States; widely referenced worldwide | Choice and validation of a suitable CCI method; preference for deterministic methods | Deterministic, quantitative method; validation support in the feasibility study |
| USP <1207.1>, <1207.2>, <1207.3> | As above | Lifecycle testing; leak test technologies; package seal quality | Method described against the technology chapters (mapping to be confirmed) |
| EU GMP Annex 11 | Europe | Computerised systems: validation, audit trail, data integrity | Data recording designed for Annex 11 (features to be confirmed per configuration) |
| FDA 21 CFR Part 11 | United States | Electronic records and electronic signatures | Part 11 support to be confirmed |
| PIC/S GMP Guide | Participating inspectorates worldwide | GMP aligned with the EU guide, including Annex 1 | As for EU GMP Annex 1 |
| ICH Q9 (R1) | Global | Quality risk management, including contamination control | Quantitative data supports risk-based decisions |
Statements marked in amber need confirmation by ASTRACEC before publication. This page is guidance, not a regulatory opinion.
For your validation file
Documents for your validation file.
The typical documentation for a qualified machine. The exact set is agreed for each project.
Design documentation
Functional and design specifications for your configuration.
Acceptance tests
Factory and site acceptance test protocols and reports (FAT and SAT).
Qualification support
Templates and support for IQ, OQ and PQ on your bags.
Document set and available languages to be confirmed by ASTRACEC.
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.