For manufacturers

A wide range of companies and other organisations work daily with medical packaging, or so-called sterile barrier systems (SBS), including medical device manufacturers (MDMs), distributors, and Central Sterile Services Departments (CSSDs).

In this section, the SBA has gathered together useful information about different sterile barrier systems, types of SBS materials, types of medical packaging, validation processes and packaging equipment, as well as the latest regulations.

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Manufacturing the medical devices (MD)

Material types

Typical material types used for sterile barrier systems are Click here to view the SBA’s Sterilisation compatibility table and learn more about material compatibility with different sterilisatio

Packaging equipment

Machines for primary packaging can be divided into 5 categories: FFS, flowwrap, 4SS, tray sealers and heat sealers

Packaging formats

Various packaging formats are available to meet the specific requirements of different medical devices, sterilisation methods, and user needs.

Packaging types

One of the skills of SBA members is in matching the packaging types and materials to the medical device and to the sterilisation process.

Regulatory overview

Over the past 30 years, the medical technology industry has developed an amazing number of life-saving and life-enhancing products. These products and therapies have helped millions of patients to liv

Sterilisation compatibility

The Sterile Barrier Association (SBA) has developed a guidance document on the Compatibility of materials used for Sterile Barrier Systems with sterilisation processes.

Validation process

The package designs of sterile barrier systems (SBS) must be validated (qualified), and the packaging process must also be validated and controlled.