Sterilisation methods for Flextrus healthcare packaging
Individual products in the Flexpeel range meet the specific requirements of steam, gas (ETO) and/or irradiation sterilisation methods. All these products allow the penetration of a sterilisation medium whilst maintaining optimal bacterial barrier and mechanical resistance properties until usage.
Steam sterilisation uses steam heated to 121–134 °C. The sterile barrier system contains at least one porous web, which enables steam to penetrate the sterile barrier system and to subsequently be evacuated again. A selection of Flexpeel® Paper materials is suitable for steam sterilisation.
Gas sterilisation uses a chemical agent (i.e. ethylene oxide, ETO) and can be used for products sensitive to high temperature. The sterilisation temperature ranges from 30 to 60°C. Again, the method requires at least one porous web such as certain Flexpeel® Paper materials.
Irradiation (gamma or E-beam) sterilisation can be used on both porous and impermeable sterile barrier systems. A compatible material is required to prevent changes in the physical properties of the sterile barrier system. A range of Flexpeel® Paper, Flexpeel® Film, thermoformable materials as well as our alu containing laminates Transofoil® and Foilbond® are well suited for radiation sterilisation.
- Accurate and consistent quality
- Minimized contamination risk
- Minimised risk for mix-up
- Complete traceability
- Hygiene procedures and training of personnel
- Line clearance procedures
- A well-defined production process
- Quality checks with approved test methods and final release
- Delivery certificates
- Extensive claim procedure (fast response for ring-fencing & corrective action)
- Change control - routines for information on parameter changes
- Controlled waste management (i.e. printed material)
- Thorough documentation at all stages of operation
- Extended documentation filing
- Checklist for documentation
- Documentation of line clearance
- Documented traceability
- Well-defined routines for customer information