Specific Functions of Medical Heat Sealing Sterilization Pouches

1. Sterile Barrier Function

Core Function:

Microbial Barrier:

The material has a pore size of ≤0.5μm, completely blocking bacteria, fungi, and other microorganisms (in compliance with ISO 11607).

Microbial challenge testing has demonstrated a barrier efficiency of ≥10⁶ CFU against Bacillus subtilis var. niger (ATCC 9372).

Preventing Secondary Contamination:

The seal strength of the heat-sealed edge must be ≥1.5N/15mm (EN 868-5), ensuring it will not be accidentally opened during transport or storage.

Applications:

Terminal sterilization packaging for high-risk medical devices such as surgical instrument kits, implants, and catheters.

2. Sterilization Media Penetration and Residue Control

Compatible with Different Sterilization Methods:

Critical Control Points:

EO Residual: EO residue in the pouch after sterilization ≤ 4 μg/cm² (ISO 10993-7).

Post-Irradiation Material Stability: PP/PE film tensile strength loss <10%.

3. Physical Protection and Device Storage

Multiple Protection Features:

Punch Protection:

The composite layer structure resists punctures from sharp objects.

Moisture and Oxidation Resistance:

The water vapor transmission rate (WVTR) of the aluminum foil composite pouch is <0.01 g/m²/day (suitable for hygroscopic devices).

Light Protection:

Opaque materials (such as blue Tyvek®) prevent degradation of light-sensitive devices.

Typical Applications:

Environmentally sensitive devices such as orthopedic implants and drug-eluting stents.

4.Heat Sealing Sterilization Pouch FAQs

• What is the difference between medical heat-sealing sterilization pouches and ordinary plastic bags?

Key differences:

Material: Medical pouches use Tyvek® or medical-grade composite film and have passed ISO 10993 biocompatibility testing; ordinary pouches are mostly made of PE/PP and are not sterilization-compatible.

Sealability: Medical pouches must meet heat seal strength ≥ 1.5N/15mm (EN 868-5). Ordinary pouches only meet daily packaging needs.

Sterilization compatibility: Medical pouches must pass EO/irradiation/steam sterilization validation. Ordinary pouches may melt or release hazardous substances when exposed to high temperatures.

For example:

Ordinary plastic bags will deform during steam sterilization at 121°C, while medical pouches can withstand high temperatures and maintain a sterile barrier.

• How can I determine if a heat-sealing sterilization pouch is qualified?

Required Documents:

Declaration of Compliance with ISO 11607-1 (Terminally Sterilized Medical Device Packaging)

Microbial Barrier Test Report (ASTM F1608 or ISO 5635)

Biocompatibility Report (USP Class VI or ISO 10993)

On-site Inspection:

Seal line width ≥ 6mm, free of bubbles and wrinkles

Dye penetration test (methylene blue) shows no leakage

• How are the heat sealing parameters for sterilization bags set?

General parameter range:

Temperature: 170-190°C (adjusted depending on material)

Pressure: 0.25-0.35 MPa

Time: 1.5-3 seconds

Note:

Seal strength verification is required before first use.

Calibrate the heat sealer daily with a standard test strip at startup.

• Can sterilization bags still be used after their expiration date? Prohibited Use:

Expired materials may deteriorate, resulting in:

Decrease in seal strength (peel test <1.0N/15mm indicates failure)

Loss of microbial barrier function

Disposal:

Destroy as medical waste (infectious waste category)

• Can sterilization bags be reused?

Absolutely Prohibited:

The sterile barrier is compromised after opening

Second heat sealing cannot guarantee seal integrity