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.

Fundamental functions:

  • 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)

Efficient documentation:

  • 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