The technology, which was unveiled at this year’s CPhI conference in Germany, is a new version of its polvinylidene fluoride (PVDF) resin that is tolerant to a range of sterilisation processes including ultraviolet irradiation and use of concentrated acids or halogens.
The product is supplied in either a powder or pellet format for conversion into a wide variety of film, tube, fitting and components. The primary target is for the single use manufacturing platform.
Arkema corporate communication manager Jacques Badaroux told in-PharmaTechnologist.com the new product builds on Kynar’s 25 year pedigree in the pharmaceutical manufacturing industry.
He explained that the current trend away from small molecule, blockbuster drugs toward large molecule, individualised medicines “shifts the manufacturing strategy from primarily capital intensive, fixed stainless steel systems to flexible plastic single use systems.”
Badaroux went on to say that unlike the “plastics, such as PE and EVA dominate the single use [manufacturing machine] market,” Kynar Rx functions across a broad range of chemistries, enabling higher working temperatures, minimising the interaction with process fluids, and decreasing the extractable profile.
He highlighted the resin’s “ability to withstand gamma irradiation, steam or chemical sterilisation techniques without the use of additives,” as its key advantage, explaining that: “this provides flexibility to the pharmaceutical manufacturer and eliminates risk to the product stream due to contamination by impurities.”
A specific area of application for this technology is in single use bioreactors for cholesterol dependent cell lines. Badaroux added that: “Bags made from Kynar Rx resins have demonstrated limited interaction with the cholesterol and allow cell growth similar to stainless steel reactors.”
Badaroux forecast that the continuing growth of the “single use” sector coupled with the advent of a contact material that can displace stainless steel presents a unique opportunity for significant growth for Arkema.
He concluded that: “Like stainless steel we believe end users can simply specify ‘Kynar in contact’ and simplify the validation process.”