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Ensuring Sterility: Aseptic Presentation and Sterile Barrier Systems in Medical Packaging

To ensure the utmost sterility and prevent infections, healthcare providers play a critical role by adhering to stringent protocols and effectively utilizing sterile barrier systems. This approach guarantees that sterile-packaged medical devices reach patients in pristine form.

Global 2023-08-02

Safeguarding Patient Safety - The Key to Minimizing Risk through Material Selection in Sterilization Packaging

SIGMA invited Robert, an experienced OR nurse with over 10 years of experience and a discerning eye for choosing contamination-free packaging materials, to share his insights on how the materials used in sterilization packaging impact the sterile barrier system and minimize patient risk.

Global 2023-07-12

Inside the Operating Room: A Nurse's Perspective on the Vital Importance of Sterile Products

What do nurses in the operating room (OR) care most about sterile products? SIGMA will share insights from medical professionals to get their take on what matters most to them.

Global 2023-05-05

Latest ISO 10993 Standards and Guidelines for Biocompatibility Evaluation of Medical Devices and Medical Packaging

The ISO 10993 series of standards govern biocompatibility evaluation procedures and methods for medical devices. Since the 1990s, designers and manufacturers of medical devices have been required to adhere to these critical core specifications.

Global 2023-01-09

Smart Manufacturing Transformation — the Next Step for the Medical Packaging Industry

SIGMA has accumulated a wealth of experience in the medical sterilization industry over the past 40 years. As we face a highly competitive global business environment and enter the new age of automati

Global 2022-05-20

The importance of a sterilization process and toxicology in sterile barrier system selection

In the first part of selecting a sterile barrier system, we delved into various considerations such as the packaging method and the selection criteria for the packaging materials. It follows that.....

Global 2022-01-18

Things You Should Know When Selecting a Sterile Barrier System

An essential function of a sterile barrier system (SBS) is to prevent nosocomial and healthcare-associated infection (HAI).

Global 2021-11-04

Design and Development Requirements for the ISO 11607-1 Packaging System

A sterile barrier system (SBS) shall be established, recorded, implemented and maintained in the design and development processes of the system.

Global 2021-10-01

“Shall be recognized as such” — Sterilized Packaging Labeling for Medical Devices

Many of those reading the standard for the first time may think it simply means fixing the sterile symbol on to the package.

Global 2021-05-25

Identification of Parameter Variables in the ISO 11607 Sealing Process

The heat-sealing process can directly affect the outcomes of packaging materials tests and the maintenance of the sterile barrier system.

Global 2021-05-12