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14 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Manufacturing W ith the increase in drug products targeted to spe- cific patient groups, including orphan drugs and even individualized medicine, manufacturers must consider how to optimize the manufactur- ing process for aseptic fill/finish of drugs in small batch sizes. Phar- maceutical Technology spoke with Joerg Zimmermann, vice-presi- dent of Development Service and External Affairs at Vetter, about these challenges and the equipment and facility options to consider. Challenges PharmTech: What are some technical and economic challenges for aseptic fill/finish of small production quantities, compared to larger quantities? Zimmermann (Vetter): The most common batch size in commercial aseptic fill/finish is between 10,000–200,000 units. For this mid- size manufacturing [range], the greatest challenge is the need for highly automated lines with optimized yields and output. The filling lines are often used for multiple products, which puts an increased emphasis on batch changeover times. A high overall equipment ef- ficiency and utilization of the cleanroom equipment are key. Even larger commercial quantities, exceeding 200,000 units per batch, usually involve mono-lines/isolators with optimized produc- tion processes. The focus of aseptic manufacturing here is on one product and one packaging configuration only. An example is in- sulin cartridges for diabetes. In the case of small commercial quantities, for instance for orphan drugs, batch sizes vary from 500–3000 units. Although vials are the standard primary packaging for such products, there is a trend Filling Small Batches Jennifer Markarian Advances in automation and cleanroom technology improve efficiency for small commercial quantities of aseptically filled drug products. NORDRODEN - STOCK.ADOBE.COM