Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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Page 44 of 61

Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 45 (RTU) offerings. RTU components enable drug manufacturers to streamline manufacturing operations by eliminating many of the processes related to component preparation. They allow pharmaceutical companies to focus their efforts on drug product development and processing b y i mp r o v i n g o p e r a t i o n a l e f f i c i e nc y a nd sharing regulatory and compliance burden with the component suppliers. New approaches result in new challenges Barrier technology and f lexible fillers provide numerous benefits to the fill/finish processes, but these advancements in technologies often re su lt i n new cha l lenge s for d r u g produc t m a nu f a c t u r e r s a nd p a r e nt e r a l p a c k a g i n g component suppliers. Because of the design intent of barrier tech- nology, there is limited or no direct human in- teraction with the interior filling area. Without direct access to the filling lines, the methodol- ogy for transferring components onto the filling line has to change. Component transfer mod- ules, rapid transfer ports, vaporized hydrogen peroxide airlock systems, and debagging and denest i ng /det ray i ng systems a re com mon ly used to aseptically transfer components onto to the filling line within RABS or isolators. With the design intent of f lexible fillers, there is a decreased footprint requirement, and often RTU components a re used as a mea ns to re- duce additional footprint needed for component preparation. Most commonly f lexible fillers use traditional methodology for handling the com- ponents, filling of the drug, and closing of the containers. However, f lexible fillers that incor- porate robotics to handle components, fill the drug, and close t he containers of ten require completely new formats of packaging compo- nents in order to operate. Flexible fillers com- monly require the containers to be packaged in nested formats, but in addition, robotic systems require t hat a l l closure components are a lso within nested formats. Addressing the new parenteral packaging component user needs To a lign wit h t he requirements and needs of these advancements in processing equipment, parenteral packaging component suppliers are not only expanding RTU component offerings, but are also incorporating the RTU packaging components within various packaging systems, such as tubs and nests and ported bag, to en- able more sea m less i nteg rat ion a nd compo- nent transfer onto filling lines. The packaging systems of the RTU components are a crucial aspect. The packaging systems have multiple functional requirements beyond simply being a vessel to carry components from point A to point B. The packaging systems must: • Withstand the target sterilization mode needed for the components and also enable the components to be effectively sterilized. • Maintain packaging integrity through- out the targeted expiry, intended use, and shipping/transit, thus ensuring that specifications such as sterility and particulate levels are maintained. • Function in accordance to design intent and equipment design, such as the appropriate docking of a ported bag to an alpha port on a RABS or isolator.

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