Terminal Sterilization: On the Safe Side The article discusses terminal product sterilization, a major packaging quality requirement for both liquid and solid pharmaceuticals
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erminal sterilization protects filled pharmaceuticals from microbes and ensures they are safe to use. However, the sterilization process is subject to differing requirements depending on both medication and primary packaging, posing various challenges to pharmaceutical manufacturers. How high can a sterilizer's temperatures be without damaging the efficacy of temperaturesensitive drugs? What pressure conditions are needed to maintain the containers' stability? Sterilization tests help to determine each product's processing parameters, from supporting pressure to loading procedures, thereby ensuring pharmaceutical product safety. At first glance, a syringe reveals little about how complicated its production is. It actually involves a very complex process, from developing the solution, choosing and filling the packaging to designing the container. Even after filling, the process is not yet completed. For instance, depending on the active ingredients, many countries require terminal sterilization of pre-filled syringes to ensure the safety of both product and patient. Parenterally administered pharmaceuticals, such as heparin preparations in syringes and infusion solutions in bags or bottles, generally place high demands on the sterility of the packaging. All these products need to remain free of microbes to prevent infections after administration. Terminal sterilization of the packaged drugs eliminates microorganisms to the maximum extent in accordance with official regulations. The challenge of plastics
Isa Alkan Sales Director SBM Schoeller-Bleckmann Medizintechnik Ges.m.b.H. Bosch Packaging Technology Pharma Bio World
Especially for new products, pharmaceutical manufacturers increasingly rely on customized packaging solutions made of plastic. These are often developed in close cooperation with primary packaging manufacturers to fulfill very specific design and marketing requirements.
During terminal sterilization, however, plastic containers may burst, warp or lose strength, making them unusable. Potential negative impacts on the product's final validation entail long delays and additional costs for the manufacturer. As a result, pharmaceutical and packaging producers must create the ideal sterilization conditions for different types of medication and containers. Here, invaluable support is provided by suppliers of sterilization equipment with a wide range of productspecific processes and comprehensive sterilization tests. Terminal sterilization is precisely tailored to pharmaceutical requirements. Depending on the medication and the approved procedure, different cycle times, temperatures and sterilization media are needed to ensure the containers remain sterile and intact, and the filled ingredients maintain their integrity. This can be accomplished by various different sterilization methods. Among the industry's most common and preferred methods are the vacuum-steam process, the steam/air mixture process, and the hot water shower. Modern combined systems incorporate multiple processes within a single sterilizer, thereby offering much greater flexibility in terminal sterilization. The appropriate process for each product Solid and porous equipment, pre-filled ampoules and blister-packed products are sterilized using the vacuum-steam process. The air is completely evacuated from the pressure chamber and containers, ensuring saturated steam to penetrate even into the tiny cavities of porous items like plastic stoppers. The latter are subsequently heated and sterilized by inflowing pure steam. Depending on the type of load, the process finishes either with vacuum drying or jacket cooling. Open, semi-sealed and completely closed containers such as vials and pre-filled October 2016 ď‚„ 39