Fortem: A platform film built for bioprocess

Fortem: A platform film built for bioprocess


The increase in adoption of single-use bags for manufacturing biopharmaceuticals has been driven by the many advantages it offers. However, the materials of construction can be more complex than conventional stainless steel vessels. Single-use containers are constructed from plastic films, which are often composed of several layers of polymers with additives for processing and performance.

The diversity of applications for single-use containers requires film that can achieve a wide variety of performance attributes such as mechanical strength, flexibility, biocompatibility, and suitable gas barrier properties to name but a few. The right balance of chemical composition and film architecture is critical for achieving desired performance across many applications.

With single-use bags at nearly every stage of bioprocessing, it is important that if different films are used for different single-use products, individual product qualifications must be conducted. Often this means several different single-use bag qualifications to cover the entire process.

To improve film quality and simplify the qualification process, GE Healthcare is launching their Fortem™ one film, a single-use platform film at Interphex this week. This platform film will be used for their entire portfolio of single-use products. Thus enabling a single qualification for multiple single-use bags in a process.

Fortem was designed specifically for bioprocess applications and GE Healthcare partnered with Sealed Air Corporation, a manufacturer of primary films for pharmaceuticals, in the design and manufacturing. In addition, GE material science experts worked closely with customers to design a film that would meet the critical quality attributes required for a platform bioprocess film.

Fortem Critical Quality Attributes

Other Key attributes of Fortem include:

  • Well characterized – specific analytical work to identify and control degradative products.
  • Developed in accordance with the latest industry guidance – in particular the BPOG extractables testing protocol.
  • Qualified using new methodologies for film failure – included tests for flexural fatigue, weldability, and abrasion resistance.

Fortem Architecture

The film’s ten layer architecture includes a contact layer that is composed of an olefin resin blend with a low extractables profile and strong weldability characteristics.

Fortem 10 layer film architecture

 

Suitable for the Entire Process Train

Fortem Application Versatility

 

Security of Supply

To ensure consistent performance and protect from supply disruptions, GE Healthcare has developed a business continuity plan which is ISO22301 accredited. It includes robust site preventative and recovery plans, a ten-year strategic supply agreement, and strategic safety stocks in both raw materials and finished film.

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