Sterile barrier system (terminally sterilised medical devices) enables sterilisation and maintains sterility of items by package integrity. Sterile barrier system must give certainty of sterility throughout all the chain. This is enabled by packaging design, material and validation.
SteriPack offers fully integrated single source solutions, as well as design expertise and assistance, to meet the customer’s packaging and labelling requirements. Products can be packaged in numerous formats, from small batches to large scale formats.
The packaging system must be designed to minimize the safety hazard to the end user and patient under intended specified conditions of use. To accomplish the requirement SteriPack applies risk analysis techniques throughout the entire design and development system right through to commercialisation.
The packaging services we offer include:
- Manual pouching
- Soft blisters form, fill & seal packaging
- Rigid blisters form, fill & seal packaging
- Labelling and printing
- Secondary and tertiary packaging
Packaging process validations
Medical devices packaging validation process is regulated to ISO 13485:2016 and compliant to MDD 93/42/EEC, Annex II. EN-ISO 11607 Medical packing:
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Typical validation scope for packaging services from design phase to production launch:
- Validation plan
- Equipment validation IOQ
- Product testing pre-DOE
- Final validation report
pouches, blisters, trays, solid bleached sulphate cartons, corrugated cartons.