For high-volume biopharmaceutical applications
Merck Millipore has expanded its single-use film offerings with the addition of PureFlex Plus film, a robust, durable product used in the construction of Mobius single-use process containers for biopharmaceutical manufacturing.
The film's robust outer layer offers strong resistance to leak formation, making it suitable for the demanding applications often encountered in large-volume operations.
The PureFlex Plus film builds upon Merck Millipore's PureFlex film technology, which was introduced in 2006 and has since been used by customers throughout the drug manufacturing process.
PureFlex Plus adds a new, more robust linear low density polyethlene (LLDPE) outer layer, which reduces susceptibility to leaks through abrasion, puncture, stretching and tearing. The inner layers are identical to the original PureFlex product and offer the same well-characterised extractables profile and gas barrier properties. Because the fluid contact layer is the same in both films, current users can incorporate PureFlex Plus technology with reduced validation requirements into their film use. Merck Millipore will continue to offer the original PureFlex film for customers who do not wish to change products.
‘Biopharmaceutical manufacturers are increasingly incorporating single-use components into their processes to maximise efficiency and reduce costs,’ said Andrew Bulpin, Executive Vice President of Merck Millipore, Process Solutions. ‘The versatility of the single-use PureFlex film has allowed it to be used throughout the entire production process, limiting validation and implementation effort. The enhanced PureFlex Plus film adds further robustness to our proven film technology, helping to ensure process container integrity even in physically stressful applications.’
Similar to its predecessor, PureFlex Plus is a high purity, medical grade, coextruded film designed to provide strength, flexibility, low gas permeability, and an inert product contact layer. The fluid contact material is made of ultra low density polyethylene (ULDPE), the gas barrier layer is polyethylene vinyl alcohol copolymers (EVOH), and the first outer layer is ethylene vinyl acetate (EVA). All contact layers are free of animal-derived components and comply with the Food and Drug Administration regulation 21 CFR 177.1520. Using Merck Millipore's EZ fold technology, these flexible films allow for high-volume bag assemblies (>500 L) to be filled in a bin without operator manipulation or the use of a hoist.