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PACKAGING

PACKAGING

Mixed Reels  |  Tyvek® Reels |  Downloads

PACKAGING

All MATACHANA packaging systems are accepted within the requirements of the SBA (Sterile Barrier Association) and ensure the preservation of sterile conditions up to 365 days.

MIXED REELS

Product manufactured with a face of medical paper of 60 g/m2 and other side of a complex of PET/PP in blue color, with 12/40 µm of thickness.

It is presented in mixed reels, it complies with the following standards:

  • ISO 11607-1: Packaging for terminally sterilized medical devices. Part 1: Requirements for materials, sterile barrier systems and packaging systems.
  • EN 868-5: Packaging for terminally sterilized medical devices. Part 5: Sealable pouches and reels of porous and plastic film construction. Requirements and test methods.
  • Manufactured under the quality standard ISO 13485: Medical devices. Quality management systems. Requirements for regulatory purposes.

Wrapping material are accessories to these products and are therefore subject to the legislation (directive and/or regulation) on medical devices which are classified as class I products. For this reason, the product has CE mark on the boxes and reels. Our customers can ask for the certificates of analysis for each lot number.

TYVEK® REELS

Tyvek® is a packaging material that offers extreme resistance to tearing and bursting during sterilization processes, with exceptional barrier properties. It is suitable for use in ethylene oxide, gamma radiation, Low Temperature Steam with Formaldehyde (LTSF) and Hydrogen Peroxide, both Plasma and Vaporized. Steam sterilization is also possible if the temperature does not exceed 128 ºC.

MATACHANA brand Tyvek® reels are manufactured from Tyvek® 1073B, which provides the highest level of protection, making it ideal as a choice for packaging medical devices that require high strength and a high level of microbiological barrier.

Manufactured from clear, 12/50 thick, high-density polyethylene (HDPE), Tyvek® offers exceptional protection against possible deterioration from sharp surfaces or very heavy materials. Its strength makes Tyvek® 1073B protect and maintain the sterility of high-risk products.

MATACHANA reels are available in 70 meter long rolls of different widths. The inner mandrel (cylinder) on which the reel is wrapped has an internal diameter of 76 mm.

Tyvek® is a registered trademark of DuPont de Nemours, Inc.

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