Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 43 generally require four to six hours. The aseptic SBV also makes it possible to downgrade the surrounding cleanroom environment because of the integrity of the approach, again generating further time and cost savings. Conclusion The key to advanced aseptic processing is the elimination and absolute control of all sources of contaminants, including human-generated contaminants. The selection of an appropriate barrier containment technique will be dependent on several factors, including the requirements of indiv idua l ma nufacturing faci lities a nd t he types of products being processed. Choosing the right contamination control platform requires considerable research into what a product needs for an effective process design. While ease of decontamination and a high degree of steri lit y assura nce ca n be readi ly achieved using isolators, RABS bring increased operational f lexibility and speed of changeover which appeals to manufacturers that need to adapt to varying requirements from different customers. Aseptic SBV technology not only complements and works in harmony w it h t hese solutions, but can, in many circumstances, eliminate the need for other methods. For manufacturers who require high-speed com mercia l ma nu fac t u re, ba r r ier isolat ion technolog ies may ma ke business sense. For smaller batch sizes, a more f lexible RABS solution may be more suited to the process. Reference 1. ISO 14644-7: Cleanrooms and Associated Controlled Environments—Part 7: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators, and Mini-Environments) (2004), PT The split butterfly valve approach offers manufacturers a closed handling method that reduces the resource associated with cleaning and validating large areas and minimizes the need for manual intervention, all while achieving the necessary sterility assurance level. For more on aseptic manufacturing, please visit to read the following articles: • Considerations for Seals in Split Butterfly Valves Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully. seals-split-butterfly-valves • Moving to Closed Systems for Aseptic Processing Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility. systems-aseptic-processing • Preventing Contamination During Sterile Powder Transfer A chlorine dioxide sterilization cycle was developed for a novel split-valve aseptic powder transfer device. during-sterile-powder-transfer • Ensuring Sterility in Small-Scale Production Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches. small-scale-production-0 RELATED ARTICLES

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