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18 BioPharm International ® Manufacturing and Facilities eBook November 2024 www.biopharminternational.com MICHAELVI - STOCK.ADOBE.COM B iopharmaceuticals should be produced in facilities that meet good manufacturing practice (GMP) requirements. Using old- er facilities and/or outdated equipment to manufacture biopharmaceutical products can make meeting regulator y and qualit y require- ments dif ficult and may lead to dr ug shor tag- es and higher operating costs (1). An increased amount of product rejections and recalls may also occur (1). Factors that contribute to these risks in- clude damaged structures, difficult to remove mold, and a lack of a rigorous maintenance program that includes everything from walls to air vents, to pest control (1). Poor facility design, a lack of proper oversight, and inefficient space are also contribu- tors to the risk associated with outdated facilities and/or equipment. Facilities should be appropriate for their intended use, and companies must be sure the facilit y they a re using to ma nufact ure biopha r maceut ica ls is capable of meeting environmental requirements, such as those for particulates, graded space, and air changes, according to Kenneth LaRiviere, head of Engineering at Andelyn Biosciences. "Differential pressure is another critical parameter for operations in bioprocessing facilities," he continues. "You must be able to maintain your pressure cascades as neces- sar y to ensure a clean, compliant environment for your operat ions. La m i na r it y a nd un id i rec t iona l f low are critical if you are working in Grade A space, as well as other conditions such as temperature and humidity." Cleanliness is another key element in ensuring quality of biopharmaceuticals. However, in the past, facilities were not of ten built to be easy to clean, specif ies La Riv iere. "Today's spaces a re bui lt for cleanliness. Floors are impervious. Intersections of horizontal and vertical surfaces are coved. Cleaning is critically important. If you can't clean your facil- ity, you really can't operate," he says. Quality Pitfalls of Aging Facilities and Equipment Susan Haigney Operating in an aging facility and/or utilizing outdated equipment may lead to drug shortages and high operating costs.