Medical Sterile Pouch Introduction

Product Overview

Medical sterile pouches are among the most widely used and versatile packaging formats within the Sterile Barrier System (SBS) for medical devices. Designed for terminally sterilized medical devices, these pouches allow the entire packaged device to be sterilized after sealing and maintain the internal sterile environment throughout its validated shelf life. We offer a comprehensive portfolio of sterile pouch solutions including medical-grade paper pouches, Tyvek® pouches, all-plastic pouches, and foil laminate pouches. All products are manufactured in strict compliance with ISO 11607 and EN 868 series standards, serving a broad range of applications including surgical instruments, syringes, catheters, and extracorporeal circuit tubing.

Product Types and Configurations

By Structural Format

Flat Pouches (3-side-sealed) : Pre-formed with three sealed sides and one open side. Simple and cost-effective, ideal for small instruments and consumables.

Roll Stock/Tubing Pouches : Supplied in roll form, allowing users to cut to desired length, seal one end, load the device, and seal the other end. Offers high flexibility for variable instrument sizes.

Header Bags (Ventilated Pouches) : Feature a transparent film on one side and breathable material (paper or Tyvek®) on the other, combining visibility with sterilization gas permeability—the most widely used pouch format.

Self-Seal Pouches : Utilize a medical-grade adhesive strip for closure without heat-sealing equipment. Convenient and ideal for clinics and small healthcare facilities.

Stand-Up Pouches : Feature a three-dimensional structure suitable for larger or irregularly shaped devices.

By Sterilization Compatibility

Our pouches are compatible with all major sterilization methods including Ethylene Oxide (EtO), Gamma/E-beam irradiation, Steam (autoclave), and Low-Temperature Plasma.

Core Material Characteristics

Medical-Grade Paper Pouches

Constructed from medical-grade breathable paper heat-sealed to a transparent laminate film (e.g., PET/LDPE). The paper side provides gas permeability essential for EtO and irradiation sterilization. Domestic and imported papers (Swedish, French, etc.) are available based on requirements.

Tyvek® Pouches

Manufactured using DuPont™ Tyvek®, a flash-spun high-density polyethylene material (common grades include 1073B and 1059B). Key advantages include:

Superior Physical Strength: Provides up to 6 times greater puncture and tear resistance compared to medical-grade paper, ensuring device protection

Excellent Microbial Barrier: Dense continuous-fiber structure prevents bacterial penetration

Broad Sterilization Compatibility: Compatible with EtO, irradiation, and Low-Temperature Plasma sterilization

Clean Peel with Low Linting: Minimal fiber shedding upon opening, reducing particulate contamination risk in the sterile field

All-Plastic Pouches

Manufactured with plastic film on both sides (e.g., LDPE/HDPE). Suitable for irradiation sterilization only-1. Due to limited breathability, all-plastic pouches are not recommended for EtO sterilization due to risks of incomplete sterilization or gas residue-1. Pharmaceutical-grade LDPE sterile pouches are widely used for APIs and intermediates, featuring extremely low ionic content, black spots, and crystallinity—available with gamma irradiation sterilization-9-12.

Quality Assurance

All sterile pouches are manufactured and converted in controlled cleanroom environments under an ISO 13485 quality management system, fully compliant with ISO 11607 standards-4-6. Products feature chemical indicators meeting ISO 11140-1 requirements, providing clear visual confirmation of sterilization exposure-4. Each batch is accompanied by a comprehensive quality inspection report, ensuring full compliance with medical device regulatory requirements.