Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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Page 40 of 61

Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 41 RABS RABS have been designed to enhance the aseptic processes carried out in conventional cleanrooms. These systems put a physical barrier between op- erators and processing lines, while still offering the f lexibility to interact with the process. To en- able the use of a less restrictive barrier, RABS are required to be set up in class ISO 7 cleanrooms, which means they do not require their own bio- decontamination system. Two different types of RABS are commonly used in today's manufacturing facilities. The first are active RABs, which actively pull air from outside the cleanroom environment, filtering and extract- ing it so that the RABS is completely isolated. The second type are standard passive RABS that use a cleanroom's heating, ventilation, and air condi- tioning (HVAC) system. RABS bring their own unique advantages by en- abling operators to maintain a distance from the process, while allowing the cabinet to be opened if further intervention is required. Processes can also be quickly turned around to suit different batch sizes and requirements. Isolators Isolators create an airtight barrier or enclosure around an aseptic processing line, hence, provid- ing complete separation between the product and the operator/cleanroom environment. Operators perform tasks through half-suits or glove ports, enabling manipulation to be undertaken within the space from outside the enclosure without com- promising integrity. The clean environment is maintained through a combination of techniques, including the use of positively pressurized chambers with closed loop control. High-efficiency particulate air (HEPA) is supplied to the chamber in a laminar f low and en- sures that particulate generation is suppressed and removed efficiently, while integrated bio-decon- tamination systems provide a validated sterility as- surance level (SAL) of 10 -6 on the chamber surfaces. Due to the high-performance requirements for these enclosures, integrated pressure decay tests have become the norm during start-up and prior to any bio-decontamination phase, with the leak of the chamber being a key factor in the classification of the device. More information can be found via ISO14644 (1) on leak rates for separative devices . Weighing up the advantages of isolators and RABS Isolators and RABS both offer rigid wall environ- ments that provide a physical and aerodynamic barrier between the operator and the sterile drug manufacturing process. While both provide an ISO 5 cleanroom environment, they each have their own unique advantages and limitations. One of the major benefits that isolators have over most RABS is that the interior can be decontami- nated through an automated process. This allows for repeatable and consistent high-level bio-decon- tamination providing increased SALs over conven- tional cleanroom manufacturing. Comparably, most RABS rely on the use of manual cleaning processes. Pharmaceutical manufacturing environments are open to multiple sources of contamination from the air filtration systems to the process of materials transfer.

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