GE Healthcare has developed Fortem™ film, a technology for creating a platform of single-use bags for all stages of bioprocessing. It succeeded in making a multilayered film with high performance on all levels, no compromises.
“With Fortem film technology, we’ve really taken a step forward in the life cycle management of single-use materials,” says Ross Acucena, Product Strategy Manager at GE Healthcare. “We need to continuously improve our management of critical component materials at the supply chain level, the material characterization level and the transparency level with which we share information. I think GE has taken a pretty big step each of those areas. These concepts are not just important to single-use film, but to all aspects of single-use.”
Single-use bags are found at every stage of bioprocessing. Fortem film is a single-use technology that is already available in several GE Healthcare single-use applications such as the WAVE Bioreactor bags. The Xcellerex stirred-tank bioreactor and mixer bags, storage bags and the HyClone cell culture media and process liquids bags are slated to launch in the coming year, says Acucena.
Dialing in properties
Fortem film was designed from the ground up, says Acucena. “The first step was to select a partner for this process, which we found in Sealed Air Corporation. Next, we defined the attributes that the new film technology should have, from our own experience, the ‘voice of our customers’ and competitive benchmarking. Achieving these desired attributes is a balancing act as there are inherent tradeoffs. One of these is to provide the right combination of barrier properties to prevent vapor and moisture transition in the film and at the same time to avoid stress cracking in high flexural stress conditions.”
To achieve this, a unique ten-layer co-extrusion film was designed, each layer with a different function. “We found that better material performance was obtained by separating the barrier layers, because these are inherently brittle. The contact layer is also unique. We have blended polyethylene, which is commonly used, with cyclic olefin copolymer, which is a rather inert material with good sealing and temperature stability performance. This combination results in a good barrier layer which helps prevent leaching and absorption and maintains a high strength at high temperatures.”
GE Healthcare chose a single platform film technology for all single-use applications. Acucena explains: “We recognized that a single material helps the customer in qualification and validation. More knowledge and familiarity with the material will provide less work and more assurance.”
Another important issue is the security of supply which Acucena feels is much easier to provide with just one material instead of many. “With these kinds of film in particular there is a need for a focus on the supply chain. Change sometimes cannot be avoided. We make sure that we have a two-year line of sight to raw material and process changes, contractual last time buy rights, raw material safety stock and a safety stock of film for a year. This ensures change can be implemented in a controlled way.”
A big issue for manufacturers are extractables and leachables (E&L), compounds that diffuse out of the films during operation. The important thing here is the risk this poses, says Acucena. “From an E&L risk perspective, Fortem film presents a very low risk profile.”
For the near future GE Healthcare is looking to expand the production capacity and introduce new products. The coming months will see the Xcellerex mixers and reactors introduced, as well the large storage bags and smaller pillow storage bags.