Pharmasafe SA

2020年6月29日,

公司的PharmaSafe遏製分裂蝶閥是專為安全處理non-sterile API和配方成分。當移動原料藥(api)和其他敏感材料在醫藥製造、專業人士擔心浪費,效率和材料的完整性。充點技術的PharmaSave分裂蝶閥是旨在幫助簡化材料轉移和消除擔心產量、汙染和其他問題。邁克Avraam製造業挑戰,充點技術,解決工程主管告訴Outsourcing-Pharma在處理高度有效的物質如api和高度有效的api (HPAPIs)在複雜的生產環境中,企業麵臨著一係列的挑戰。“在物質轉移,有效的工程控製是至關重要的,員工的安全是主要的焦點,”他說。“然而,公司也為最小中斷生產過程的目的。”Avraam指出屏障技術,光電隔離器和限製訪問屏障係統(rab),可以提供“微環境”,可能提供更好的保護和完整性水平過程比傳統的開放環境。“許多製藥公司發現使用分裂蝶閥(越南)技術集成的隔離器或rab的轉移材料的製造過程增加安全殼的完整性解決方案,”他解釋道。防止汙染sbv旨在防止汙染,運營商接觸,和交叉汙染產品的多用途的設施。流動的材料可以在一定複雜製造業和其他進程,和越南幫助增加安全、增加產量和避免成本浪費。 According to Avraam, both halves of the butterfly valve are combined during powder charging, which is intended to enable contained, efficient materials transfer. “Transferring material from one closed system into a separate closed system is one of the key difficulties in powder transfer. It’s important to ensure that the design specifications of the technology or device used in this process will meet the required accessibility, batch size and containment performance,” Avraam told us, adding that containment integrity is the primary challenge in the process. The company reports that the PharmaSafe valve line is independently validated by third parties, according to the ISPE Standardised Measurement of Equipment Particulate Airborne Contamination guideline. This guideline is intended to benchmark the performance of equipment capabilities. When handling HPAPIs, material may be moved between facilities, occasionally across geographical boundries. Devices like the SBV valves, Avraam said, can help ensure the integrity of costly, sensitive powders from place to place. “To overcome this challenge, ChargePoint Technology has introduced a single use version of the passive half of its SBV, the single use passive (SUP)," Avraam said. "This ready-to-use, off the shelf solution provides a method of contained powder transfer within facility A (drug supply) and can also be used as a product’s primary packaging and container closure for transportation to facility B (drug product formulation); in short, it provides CMOs and in-house manufacturers with the ability to handle ingredients with less risk due to the elimination of the double handling concern.” Copyright - Unless otherwise stated all contents of this web site are © 2020 - William Reed Business Media Ltd - All Rights Reserved - Full details for the use of materials on this site can be found in the Terms & Conditions