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18 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2023 PharmTech.com Cleanrooms are in need of flexibility to fulfill the needs of a multi- tude of clients and applications. Flexibility needs have been discussed for a variety of reasons and, as such, must be appropriately defined and reviewed. It should be noted that a generic approach to flexibility does not necessarily work but simply elevates costs and fails to meet requirements. Within this paper, different f lexibility attributes were listed and reviewed in regard to fulfillment of the needs by the three major cleanroom infrastructure modalities. The hope is that it serves as a tool to plan which flexibility attribute has the highest priority and how the highest flexibility priority attribute can be im- plemented with the listed different cleanroom designs, modalities, and constructions. References 1. W h it f ield, W.J, " U lt ra-C lea n room ," US Patent 3158457, May 14, 1962. 2. Levine, H.L.; Lilja, J.E.; Stock, R. et al. Efficient, Flexible Facilities for the 21st Century. BioProcess Intl. 2012 10 (11). 3. Bakeev, K.A.; Jornitz, M.W.; Noel, R.; and Balekai, S. Flexbile Facilities Roundtable. americanpharma- ceuticalreview.com, May 31, 2015. 4. Merrill, G. A Systems Approach to the Future of Cleanroom Manufacturing Flexibility. cleanroom- technology.com, Aug. 24, 2022. 5. Jornitz, M.W. Defining Flexible Facilities: When is a Flexible Facility Being Flexible? pharmaceutical- processingworld.com, April 19, 2013. 6. MJornitz, M.W. The Rapid Rise of Modular Con- struction – Are Standardized Facilities Next? phar- maceuticalprocessingworld.com, Feb. 14, 2019. 7. Swanson, D.L. Flexible Facility Design for Multi- ple Cell Therapy Processes. ispe.org, November/ December 2020. 8. Wi ker, G. Implement i ng Cha nges to a Faci l it y While It Continues to Operate. Proceedings of PDA Annual Meeting, San Antonio, Texas, 2016. ■ TABLE II. Flexibility review of three cleanroom design modalities. CAPEX is capital expenditure. HVAC is heating, ventilation, and air conditioning. Scenario Stick-built (on-site) Modular (on-site) Podular (off-site) Design completion Designs need to be fully completed before the construction is started Designs need to be fully completed before the construction is started Construction of the super structure can start without full design completion, but needs to be completed when assembly starts Shell building completion Shell building and utilities must be completed Shell building and utilities must be completed Construction and prequalification happen parallel to shell building Shell building choice Shell building roof line requires high load-bearing capacity Either, as it could be hung or built from ground-up Built from ground-up, no special structural shell building needs Cleanroom classification change Possible when the cleanroom has been designed as higher grade and needs to be lowered Possible when the cleanroom has been designed as higher grade and needs to be lowered Possible when the cleanroom has been designed as higher grade and needs to be lowered Pressure switch Possible Possible Possible Scaling out With lengthy disruption of existing processes and major clean-up With lengthy disruption of existing processes Possible, easier when the units have autonomous HVAC units Excursion actions Typically, with total shutdown Typically, with total shutdown Shutdown of one of the autonomous HVAC areas Cleanroom area expansion Possible with disruption and clean-up afterwards Possible Possible Delayed CAPEX Difficult Difficult Possible Mechanical space Typically centralized in additional mezzanine space Typically centralized in additional mezzanine space Can be in the back of the cleanroom unit or on top or tied into a centralized system Minor changes after completion Possible Possible Possible Major changes after completion Major disruption and shutdown of the processing area (months) Major disruption and shutdown of the processing area (months) The required area change can be done in newly designed units, which then replace the old unit layout (weeks) Re-use With difficulties as major refurbishing and decontamination is needed With difficulties as major refurbishing and decontamination is needed Possible, as the units can be refurbished and sanitized off-site Mobility Not possible Not possible Mobile