Description

The Bolsaplast Tyvek Heat Sealable Pouch is expertly crafted for the secure packaging of terminally sterilized medical devices. Designed for single use, this pouch ensures the maintenance of sterility and package integrity through its heat-sealable construction.

Material Composition

• DuPont™ Tyvek®: One side of the pouch is made from 100% high-density polyethylene (HDPE) nonwoven material.
• PET/PP Blend Film: The other side comprises a polyethylene terephthalate/polypropylene blend.

This medical-grade construction provides excellent peelability, minimizing the risk of film tearing, and features extremely low fibre shedding with minimal airborne particle generation upon opening.

Key Features

• Microbial Barrier: Offers outstanding protection, maintaining sterility until the pouch is opened.
• Tear Strength and Puncture Resistance: Superior to medical-grade papers, making it suitable for items with irregular or sharp edges.
• Chemical Indicators: Includes colour change indicators for various sterilization processes (Steam, EO, formaldehyde, plasma/H₂O₂), printed with non-toxic ink. These indicators change color post-sterilization but do not confirm sterility.
• Instrument Protection: Designed to avoid damage to instruments and ensure consistent package integrity after each sterilization cycle.

Sterilization Compatibility

• Methods: Compatible with ethylene oxide (EO), gamma radiation, electron-beam radiation, steam (under specific conditions), and hydrogen peroxide gas plasma.
• Performance: Tyvek® maintains its microbial barrier, strength, color, and flexibility post-sterilization.

Usage Guidelines

• Sealing: Use a constant heat pouch sealer at 120–150ºC.
• Storage: Keep in a cool, dry place away from acids, bases, sunlight, and the sterilizer. Recommended storage conditions are 10–30ºC with 30–70% relative humidity.
• Shelf Life: Before sterilization, the shelf life is 3 years from the manufacturing date under optimal conditions.

Available Sizes

• 7.5 cm x 21 cm
• 10 cm x 28 cm
• 15 cm x 32 cm
• 20 cm x 42 cm
• 25 cm x 50 cm
• 32 cm x 56 cm
• 40 cm x 58 cm

Typically, each unit contains 1000 pieces, though larger sizes may vary.

Compliance and Standards

The pouch conforms to EN868-2/3/4/5, ISO 11607-1, and AS4187 standards. It is biocompatible according to ISO 10993 and USP standards, making it suitable for environments requiring FDA and ISO 11607 compliance.