Issue link: https://www.e-digitaleditions.com/i/1499609
14 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2023 PharmTech.com COCODESIGNTONG - STOCK.ADOBE.COM C leanroom or classified environmental infrastructures have been designed and constructed for decades (1) and can be either on-site framed epoxy coated gypsum wall (stick-built), on-site assembled mod- ular wall panels (modular), or off-site prefabricat- ed cleanroom units (podular), the last of which is a relatively recent addition. All of these cleanroom material and design modalities have benefits and limitations that require careful review when mak- ing decisions on which approach to use for con- structing current good manufacturing practice (CGMP) cleanroom infrastructure. Such decisions need to be made not only with the process appli- cation needs in mind, but also with the long-term perspective on future capability and capacity. This is especially important for multi-modal or multi-product processing streams and new thera- pies, which may not have a clearly defined process design or require process modifications along the way, and contract manufacturers, as their client base require process modalities change. In all cases, the need for f lexibility is real (2,3,4). However, f lexibility must be defined, as it is often used in genera l ter ms (5). Some cla im t hat sta n- dardization of cleanroom infrastructure designs, f a s ter del iver ies, a nd lower cos t of good s sold , w i l l i m p e d e o r p r e v e n t f l e x i b i l i t y. T h i s g e n- e r a l i z at ion m ay b e i n a cc u r ate, a s s m a l le r vol- umes requi re sma l ler process foot pr i nts, wh ich can be reconfigured within the available standard- ized space (6). Such spaces may be even more flexible if units can be scaled rapidly. To tr uly determine f lexibilit y, one needs to dis- sect the different f lexibility needs and the available solutions. Only then can an appropriate decision be made, which will not just satisf y the short-term re- quirements, but also show long-term benefits. The Quest for Cleanroom Flexibility Maik W. Jornitz Principal Consultant, BioProcess Resources LLC Sidney Backstrom VP Business Management, Blake Williams VP Operations, and Dennis Powers VP Business Development G-CON Manufacturing Inc. Contextualizing what type of flexibility is needed is paramount when considering cleanroom design.