Fortem™ film - engineered for upstream bioprocessing

Bioprocessing - Fortem™ film

Fortem™ is a purposefully designed bioprocess film developed in collaboration with and exclusively for GE Life Sciences. It has been designed to be a platform film suitable for all fluid path applications in upstream bioprocessing.

Features

Fortem's 10-layer structure gives it huge structural integrity for single-use systems from 5 litres up to 2,000 litres. The make-up of the fluid contact layer provides the film with a clean, inert surface eliminating the need for small molecule slip or anti-block additives and so significantly reduces the extraction profile of the film. Fortem is designed with excellent gas barrier properties including two barrier layers to retain low oxygen transmission rates (OTR) under both wet and dry conditions. Other layers were chosen to maintain flexibility and strength properties. They include a specific high-grade polyamide that has improved strength over traditional polyamide materials in high humidity environments. The careful selection and placement of antioxidants in the film supports structural integrity while maintaining the desired biocompatibility without the risk of the negative effect of bis(2,4-di-tert-butylphenyl)phosphate (bDtBPP) a degradant of Irgafos 168, a commonly used antioxidant.
Fortem is registered with the FDA under DMF 033652. It is patented by Sealed Air and produced in an ISO 7  (Class 10,000) cleanroom with the fluid contact surface of the film only exposed to filtered air, monitored and maintained to Class 100 particulate levels during the manufacturing process. Sealed Air's stand-alone pharmaceutical production unit operates under the ISO 15378 quality system. 

Applications

  • Designed for Upstream Bioprocessing
  • Bioreactors - rocking and stirred tank
  • Fermentors
  • Cell culture media, buffers and process liquids bags