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

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

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

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

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

“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

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