The Ritedose Corporation
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.
For more information about ChargePoint Technology’s sterility assurance solutions, visit https://www.thechargepoint.com/product-filtering/?sterility-assurance
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About ChargePoint Technology
ChargePoint Technology is the trusted specialist for safe and reliable contained and sterile transfer solutions in the pharmaceutical, biotech, chemical and other process industries. Its client portfolio includes some of the top 35 pharmaceutical companies and reaches into North America, UK, Europe, China and India, amongst others.
ChargePoint Technology manufactures its cutting-edge devices in its purpose-built facility in Liverpool, UK, employs more than 90 employees across the globe and secured a multi-million-pound investment from LDC, part of Lloyds Banking Group in January 2017, to meet the increase in global demand for its products and solutions.
The product range includes:
- Containment solutions – ChargePoint’s containment solutions provide a reduced risk of cross contamination via closed transfers, ensure the safety of your personnel and provide a dust free environment when processing toxic powders and high potent APIs.
- Sterility assurance solutions – ChargePoint’s product range for sterility assurance has been developed to perform aseptic transfers that maintain critical area integrity, reduce risk of contamination via closed transfers and meet GMP and product quality requirements.
- Single use solutions – ChargePoint’s single use solutions provide the containment and sterility assurance required for handling high potent ingredients and chemicals with the cost effectiveness of disposable technology.