Sterile systems
Product. Process. Barrier.
Assess their scope together.
Sterile systems
The dossier chain for sterile supply.
- 01
Product
Exact product configuration.
- 02
Process
Scope of the validated process.
- 03
Barrier
Packaging and integrity.
- 04
Lot
Traceability and release.
Technical dossier consultation
The dossier behind a label.
- Configuration
- Confirmed at the sample and quotation stage
- Validation scope
- Confirmed at the sample and quotation stage
- Integrity and shelf life
- Confirmed at the sample and quotation stage
- Traceability
- Confirmed at the sample and quotation stage
Evidence dossier structure
- Method
- Which question is being addressed, using which method.
- Sample
- Identity of the product and configuration under review.
- Condition
- The environment and parameters of the test.
- Revision
- Document version and applicable scope.
No report is currently approved for publication.
Outer packaging and the sterile barrier serve different purposes.
Assess environment, surface, chemistry and use cycle together.