Description

The Bolsaplast Tyvek Heat Sealable Pouch is an advanced solution for maintaining the sterility of medical devices and equipment. Designed for healthcare and sterile production environments, this pouch offers a reliable packaging option that ensures the integrity of its contents until the moment of use.

Material Composition

• DuPont™ Tyvek®: One side of the pouch is constructed from high-density polyethylene (HDPE), providing an exceptional microbial barrier with low fibre shedding.
• PET/PP Blend Film: The other side features a polyethylene terephthalate/polypropylene blend, enhancing the pouch's tear and puncture resistance.

Sterilization Compatibility

This pouch is compatible with various sterilization methods, including:

• Ethylene oxide (EO)
• Gamma radiation
• Electron-beam radiation
• Hydrogen peroxide gas plasma (VH₂O₂, including STERRAD® systems)
• Steam (under controlled conditions)
• Formaldehyde

Key Features

• Microbial Barrier: Maintains sterility with low-linting properties, minimizing airborne particles upon opening.
• Physical Properties: Offers superior tear strength and excellent peelability for aseptic opening.
• Dimensional Stability: Minimal shrinkage after steam sterilization, preserving strength and flexibility.

Integrated Indicators

The pouch includes integrated chemical indicators for various sterilization methods, with non-toxic ink that ensures no damage to instruments. The colour change indicator for plasma sterilisation is printed under the seal for added convenience.

Quality Assurance

Manufactured in an ISO 7 cleanroom under GMP standards, the pouch is non-cytotoxic and biocompatible, conforming to relevant industry standards. Each batch comes with a certificate of conformity and, if applicable, a certificate of irradiation.

Design and Availability

Available in a variety of sizes, including custom options, the pouch is suitable for packaging low-profile, lightweight, or irregular/sharp-edged medical devices. Designed for heat-sealing, it performs excellently in autoclave cycles and is ideal for storage in sterile areas.

Usage Guidelines

For optimal results, it is recommended to leave at least 1 inch of space around the item inside the pouch and fill it to no more than 75% of its packing volume. Proper storage in a clean, dry environment and adherence to validated sterilization protocols are advised.