New collaboration has integrated technologies for sterile transfer of drug substances and drug products during biopharmaceutical manufacturing
Powder containment and sterile transfer solutions experts, ChargePoint Technology, have entered into a collaboration with STERIS, a provider of infection prevention and other procedural products and services, to offer a unique and integrated solution for sterile product transfer.
Integrating ChargePoint's AseptiSafe Bio Transfer Valve with the STERIS VHP Biodecontamination Systems, this offering provides users with a fully validated solution for the sterile transfer of drug substances and drug products during biopharmaceutical manufacturing.
As regulations around sterile/aseptic processing continue to expand, many manufacturers are looking for sterile transfer solutions that do not compromise operational efficiency. The ChargePoint split butterfly valve (SBV) technology enables contained transfers into a manufacturing process, providing sterility assurance during aseptic processing.
The technology reduces the need for operator intervention and for cleaning and validating large areas, leading to minimal downtime and improving efficiencies during manufacturing.
Christian Dunne, Head of Sterile Solutions at ChargePoint Technology, said: "This collaboration was a natural step for ChargePoint since we've been working with STERIS on different applications for nearly a decade. Combining expertise from the two teams ensures that we are able to offer customers across the globe a unique and efficient solution to one of today's drug manufacturing challenges."
Edward Markewitz, VHP Product Manager at STERIS, added: "We are thrilled to be working with ChargePoint Technology and its unique aseptic SBV systems in conjunction with STERIS VHP. Collectively we are meeting the technical needs of the industry and using our expertise to provide the ultimate sterile transfer solution for products."
The AseptiSafe Bio Transfer Valve uses an enhanced decontamination step, exposing the SBV discs to vaporised hydrogen peroxide (VHP) gas within a sealed chamber. This provides a validated 6-log reduction in bioburden during the drug substance transfer process and removes the need for high grade clean room environments around the process.
The STERIS VHP Generators provide an all-in-one system unit for biodecontamination in medical, biological and pharmaceutical facilities. The generators utilise STERIS Vaprox Hydrogen Peroxide Sterilant (EPA Reg. No. 58779-4 and ECHA BPR Registered) as a means of achieving dry, low temperature biodecontamination within sealed enclosures for maximum biodecontamination.