Merck Millipore Introduces PureFlex™ Plus Single-Use Process Container Film for High-Volume Biopharmaceutical Applications

Merck Millipore, the Life Science division of Merck, has expanded its single-use film offerings with the introduction of PureFlex™ Plus film, a robust, durable film used in the construction of Mobius® single-use process containers for biopharmaceutical manufacturing. The film's rugged outer layer offers strong resistance to leak formation, making it ideal for the demanding applications often encountered in large volume operations.

The PureFlex™ Plus film builds upon Merck Millipore's established PureFlex™ film technology, which was introduced in 2006 and has since been used by customers throughout the drug manufacturing process. PureFlex™ Plus film 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 of PureFlex™ Plus film are identical to the original PureFlex™ film product and offer the same well-characterized extractables profile and gas barrier properties. Because the fluid contact layer is the same in both films, current users of PureFlex™ film can incorporate PureFlex™ Plus technology with reduced validation requirements. Original PureFlex™ film will remain available, however, for customers uninterested in a film change.

"Biopharmaceutical manufacturers are increasingly incorporating single-use components into their processes to maximize 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 film 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 made of polyethylene vinyl alcohol copolymers (EVOH), and the first outer layer is made of 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.

PureFlex™ films are used in the construction of Merck Millipore's Mobius® assemblies and NovaSeptum® sterile sampling products, which can be customized for any application. Business continuity plans have been established to ensure uninterrupted global supply of these films and products.