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Analyzing ISO 11607-1:2019 Through More Than Forty Years of Medical Packaging Expertise

From a medical-grade packaging engineering perspective, the core objective of the standard is explicit: the Sterile Barrier System (SBS) must maintain its integrity over time.

Global 2026-06-10

Selection Guide for Packaging Materials for Medical Sterile Barrier Systems(SBS Packaging Solutions)

A systematic framework for SBS packaging material selection is presented herein, with focus on sterilization compatibility, product attributes and service conditions. It can be used as a practical guide for medical device manufacturers.

Global 2026-05-29

Medical Device Packaging: From “Industrial Consumables” to the Value Reorientation of “Sterile Barrier Systems”

The term “Sterile Barrier System (SBS)” was first introduced in ISO 11607-1:2006 to describe the minimum packaging required to perform specific functions of sterile packaging: allowing sterilization, providing an acceptable microbial barrier, and enabling aseptic presentation.

Global 2026-05-19

Starting from Trust: Ongoing Hospital Education and Practical Dialogue

Behind every successful surgery in the medical field stands a group of unsung heroes—the Central Sterile Supply Department (CSSD) staff. They handle the cleaning, packaging, and sterilization of large volumes of instruments daily, with each step directly impacting patient safety and medical quality.

Global 2026-04-02

Uneven Tyvek® Coating and Inconsistent Seals? Uncover the Root Causes and Efficient Solutions

As the gold standard for medical device sterile packaging, Tyvek® relies on consistent coating quality and seal integrity to ensure a reliable sterile barrier. Issues such as uneven coating or fluctuating seal strength typically stem from imbalanced process parameters, insufficient equipment accuracy, poor material compatibility, or inadequate operation and maintenance routines.

Global 2025-06-23

When Tyvek® Meets Non-Contact Coating—the “Golden Duo” Protecting the Sterile Barrier

In medical device sterile packaging, every technological advance directly impacts patient safety and healthcare quality. Traditional packaging materials—prone to tearing, limited in breathability, and risk-laden in coating processes—represent hidden vulnerabilities in the sterile barrier. The combination of Tyvek® with non-contact coating technology is setting a new standard on the “sterile battlefield.”

Global 2025-06-23

Enhancing Sterilization Practices: SIGMA’s Visit to En Chu Kong Hospital

In June, SIGMA visited En Chu Kong Hospital, an important private hospital in Taiwan, for a product exchange with the CSSD team. Through a video by the Sterile Barrier Association (SBA), we helped the CSSD staff understand the sterile barrier system, covering topics like maintaining sterility in packaging and recognizing SBS symbols.

Global 2024-06-26

Engaging Exchange Event with NTU Hospital CSSD

At the end of May, the SIGMA team visited National Taiwan University Hospital in Taipei for an insightful exchange with the Central Sterile Supply Department (CSSD) staff. Topics included medical sterilization packaging, usage scenarios, types of materials, and medical paper inspection.

Global 2024-06-26

Meet SIGMA's Resealable Film: Elevating Packaging Standards

SIGMA is proud to present our Resealable Film, tailored for perishable items like cheese and ham, bringing a thoughtful balance of functionality and design to food packaging.

Global 2024-05-28

Food Packaging Films - Easy-Peel Film: Clarity, Convenience, and Customization

Unlock the simplicity and satisfaction of hassle-free packaging with SIGMA's Easy-Peel Film. Designed to merge seamlessly with the food container, our film incorporates a special layer that ensures easy peeling, allowing consumers to access their food effortlessly.

Global 2024-05-28

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