The Ritedose Corporation, a contract development and manufacturing organisation (CDMO) with a focus on inhalation and ophthalmic products, has partnered with ChargePoint Technology to ensure the sterility of its drug substance mixing process.
ChargePoint’s aseptic split butterfly valve (SBV) technology solves the issue of charging sterile drug substance into a mixing tank by providing a sealed means of transfer. It has been selected as a solution due to its considerable cost and production benefits, such as low capital cost, small footprint and low levels of maintenance following process validation.
Christian Dunne, head of sterile solutions at ChargePoint Technology, said: “We are thrilled to be working with Ritedose, providing our AseptiSafe® Bio Transfer Valve for this key project.
“As more biologics enter the drug pipeline, many CDMOs are looking for sterile transfer solutions that do not compromise operational effiency. SBV technology is offering a flexible, low maintenance solution compared to more traditional techniques and we expect demand for this solution to increase.”
Angie Koen, VP of Technical Services at Ritedose, commented: “It was critical that we chose the right solution for this project to prevent product contamination and expensive product loss. We selected the ChargePoint AseptiSafe® Bio Transfer Valve because of its increased sterility assurance when handling sensitive ingredients such as our drug substance.”
“We have received considerable support during the project and are benefitting from significant cost reductions and process efficiencies.”
The AseptiSafe® Bio Transfer Valve uses an enhanced decontamination step to provide a validated 6-log reduction in bacterial spores during the drug substance transfer process.