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Medical & Pharmaceutical Sterile Packaging

ChromaPack provides high-integrity sterile barrier systems compliant with ISO 11607 and EN 868. We specialize in Tyvek pouches, sterilization reels, and PTP foil for global medical device and pharma manufacturers.

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Medical Sterile Packaging

Mission-Critical Sterile Barrier Systems

For medical devices and pharmaceutical products, packaging integrity is a matter of safety. Our manufacturing facility operates under strict ISO 9001 standards, delivering pouches and foils with 100% seal integrity, peelable openings, and full material traceability.

  • Standard: ISO 11607, EN 868, ASTM F88
  • Materials: DuPont™ Tyvek®, Medical Grade Paper, PET/PE
  • Sterilization: EO, Gamma, Steam, Plasma compatible
  • Documentation: Full CoC, CoA, and technical data sheets

Class 100,000 Cleanroom Production

Contamination control is at the heart of our medical packaging process. Our Tyvek® pouches and sterile reels are manufactured in an ISO-certified cleanroom environment, ensuring minimal particulate levels and maximum safety for sensitive medical devices.

Audit-Ready: Our facility is regularly audited by global medical device manufacturers and third-party inspectors.
Medical Packaging Cleanroom Production

In-House Validation & Quality Control

Every batch of medical packaging undergoes rigorous structural and integrity testing.

Medical Packaging QC Lab

ASTM F1929 Dye Penetration

Verifying 100% seal integrity to prevent microbial ingress.

Peel Strength Testing

ASTM F88 Seal Strength

Ensuring consistent peelability and structural bond strength.

ChromaPack is an ISO 11607 compliant medical packaging manufacturer in China. We specialize in Tyvek® sterile pouches, sterilization reels, and PTP aluminum foil. Our products are engineered for EO, Gamma, and Steam sterilization compatibility, featuring 100% seal integrity, peelable openings, and full batch traceability for global medical device and pharmaceutical brands.

Medical Packaging Technical Comparison

Select the optimal sterile barrier for your device or drug delivery system.

Product Category Common Use Case Key Technical Feature Sterilization Compatibility
Tyvek® Pouches Surgical Instruments, Implants Exceptional microbial barrier & tear strength. EO, Gamma, Plasma, Steam
Sterilization Reels Dental Tools, Hospital CSSD Peelable film/paper, chemical indicators. Steam, EO
PTP Aluminum Foil Blister Packs for Tablets 100% Barrier to moisture and oxygen. Aseptic Filling

Medical Packaging FAQ

Are your medical pouches compliant with ISO 11607?

Yes, all our medical sterile packaging products are manufactured to meet ISO 11607 (Parts 1 & 2) and EN 868 standards. We provide full technical validation packages for regulatory submission.

Do you provide seal strength and integrity test reports?

We perform routine ASTM F88 (Seal Strength) and ASTM F1929 (Dye Penetration) testing in our QC lab and can provide these reports with each batch upon request.

What is the shelf life of the sterile barrier?

Our standard sterile pouches are validated for a 5-year shelf life under proper storage conditions, maintaining full microbial barrier integrity.