Description

Bolsaplast offers a specialized range of medical-grade sterilization pouches designed to meet the rigorous demands of healthcare and industrial sterilization environments. These pouches provide a reliable solution for packaging and sterilizing medical devices, ensuring safety and sterility across various methods, including Steam, Ethylene Oxide (EO), Formaldehyde, plasma, gamma radiation, electron-beam radiation, and hydrogen peroxide gas plasma.

Key Features

• Material Composition: Each pouch is crafted with medical-grade paper and a blue-tinted transparent PET/PP blend film, providing excellent durability and a clear view of contents. Select variants utilize DuPont™ Tyvek® (HDPE) for enhanced microbial barrier and strength.

• Performance: The pouches exhibit extremely low fibre shedding and high resistance to tearing, ensuring integrity throughout the sterilization process. Their excellent peelability allows for easy opening without compromising sterility.

• Safety: Printed with non-toxic ink, these pouches are safe for use with medical instruments. Integrated chemical indicators for various sterilization methods offer clear visual confirmation of successful sterilization through color change.

Quality Assurance

Manufactured under stringent quality controls, Bolsaplast pouches comply with ISO 13485:2016 standards and are produced in an ISO 7 cleanroom following GMP standards. Each batch may include a certificate of conformity and, if applicable, a certificate of irradiation. The pouches conform to EN 868-2/3/4/5, ISO 11607-1, and AS4187 standards, and are non-cytotoxic as per ISO 10993-5.

Available Formats and Sizes

Bolsaplast pouches are available in various formats, including flat pouches, gusset pouches, self-sealing pouches, flat rolls, and gusset rolls. Custom sizes and formats can be requested to meet specific needs. Common pouch sizes range from 7.5cm x 20cm to 40cm x 58cm, with packaging options varying from 200 to 2500 pieces, depending on size and format.

Intended Use

These pouches are ideal for use in hospitals, clinics, and other sterile production facilities. They support autoclave cycles and provide secure sterile storage, making them a versatile choice for healthcare professionals.

Maintenance and Storage

To maintain optimal performance, it is recommended to store the pouches in a clean, dry environment and adhere to validated sterilization protocols. This ensures the pouches continue to deliver reliable results, safeguarding the sterility of medical devices and equipment.