Split Butterfly Valves Provide Safe, Efficient Delivery of Ingredients

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When moving active pharmaceutical ingredients (APIs) and other sensitive materials in the pharmaceutical process, professionals worry about waste, efficiency and material integrity.ChargePoint Technology’s PharmaSave Split Butterfly Valves are designed to help simplify material transfer and eliminate concerns about yield, contamination and other issues.
Mike Avraam, Head of Solutions Engineering at ChargePoint Technology, told Outsourcing-Pharma that companies face many challenges when dealing with potent substances such as API and High Potency API (HPAPI) in complex manufacturing environments.
“Effective engineering controls are critical during material transfer, as employee safety is the primary concern,” he said.“However, the company’s goal is also to minimize disruption to the manufacturing process​.”
Avraam points out that barrier technologies, such as isolators and restricted access barrier systems (RABs), can provide a “microenvironment” that provides a better level of protection and integrity in the process than traditional open environments.
“Many pharmaceutical companies have found that using shunt butterfly valve (SBV) technology integrated into isolators or RABS to transfer material into or out of the manufacturing process can improve the integrity of the sealing solution,” he explained.
SBVs are designed to prevent product contamination, operator exposure, and cross-contamination in multipurpose facilities.In solid dose manufacturing and other processes, where the flow of materials can be complex, SBV helps improve safety, increase yield and avoid costly waste.
According to Avraam, the two halves of the butterfly valve are brought together during the powder loading process and are designed for closed, efficient material transfer.
“Transferring material from one closed system to a separate closed system is one of the main difficulties in powder transfer. Ensure that the design specifications of the technology or equipment used in the process will meet the required accessibility, batch size and containment performance Very important,” Avraam told us, adding that seal integrity was a major challenge in the process.
The company reports that the PharmaSafe valve line is independently verified by a third party against ISPE Equipment Standard Measurement Guidelines for Particulate Air Pollution.The purpose of this guide is to benchmark the performance of device features.
When processing HPAPI, materials may move between facilities, sometimes across geographic boundaries.Devices like the SBV valve can help ensure the integrity of expensive, sensitive powders everywhere, Avraam said.
“To overcome this challenge, ChargePoint Technology introduced a one-off version of its SBV passive half, the One-Time Passive (SUP),” Avraam said.”This ready-to-use, off-the-shelf solution provides a means to transfer the contained powder (drug supply) within Facility A and can also be used as a primary packaging and container closure for product for transport to Facility B (drug product) formulation); in short, it provides CMOs and in-house manufacturers with the ability to process ingredients with lower risk due to the elimination of double-handling issues.”
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Related Topics: Contract Manufacturing and Logistics, Ingredients, Processing Equipment, API (Active Pharmaceutical Ingredient), Contract Manufacturing
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Post time: May-18-2022

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