Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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Page 41 of 61

42 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m A limitation of isolators is that they can create difficulties in transferring materials in and out of the cabinet. This system can require a docking isolator to be connected and its interior sanitized before materials can be transferred. The quali- fication of hydrogen peroxide vapor systems in isolators can also be difficult. As a result, there is a need to suspend everything within the cabinet to remove any hidden surfaces. In comparison to isolators, RABS can ensure faster start-up times, while also improving the ease of changeover. They can also bring increased operational f lexibility and reduced validation e x p end it u re . Is olators , howe ver, of fer t he advantage of higher integrity chambers for a more robust closed solution. As an alternative handling technique to these more t rad it iona l ba r r ier tech n iques, ma ny manufacturers are finding that an SBV approach can provide a more practical option in achieving assurance of product sterility. SBV technology SBV technology enables a product to be trans- ferred from one container, process vessel, isolator, or RABS to another without compromising ste- rility. The valve consists of two parts: the active half and the passive half. Generally, the active half will be attached to the receiving vessel, with the passive half attached to the discharging drum or container, such as an intermediate bulk container (IBC) or f lexible bag. When the two halves of the "butterf ly" disc are brought together, a single disc is created, which allows product to f low on the internal surface of each half. When the passive and active halves are detached, the external face remains clean and can be safely exposed to the process environment. Decontamination is able to take place in a closed environment using SBV. A gap is created between the discs when the two halves are con- nected, which enables hydrogen peroxide gas to be f lushed through. Chemical indicators are used to validate the process and ensure that full coverage of the enclosure is obtained. Biological indicators also ensure a six-log reduction in microbiological contamination has been achieved. The SBV approach of fers manufacturers a closed handling method that reduces the resource associated with cleaning and validating large a rea s a nd m i n i m i z es t he need for ma nu a l intervention, all while achieving the necessary SAL. By reducing cleaning requirements, the technique results in less downtime. Depending on the gassing system used, process- ing times when employing SBV technology can range between four and 30 minutes, which rep- resents a significant time-saving in comparison to conventional airlock systems or isolators that Tech Transfer Sealed transfers and barrier technologies have been designed to contain aseptic manufacturing processes. Isolators and RABS both offer rigid wall environments that provide a physical and aerodynamic barrier between the operator and the sterile drug manufacturing process.

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