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www.biopharminternational.com Manufacturing and Facilities eBook 2023 BioPharm International ® 7 Manufacturing: Single-uSe SySteMS Before incorporation into a manufacturing pro- cess, advanced and effective SUTs should be subject to strict integrity testing to ensure that there is no powder release or loss of sterility while also confirm- ing the product is up to general quality standards. This can include: • Construction integrity checks. The quality of the formed product is verified using visual and leak testing methods. • Strength testing. Stress tests are completed to determine the stress that SUTs can withstand before rupturing or breaking. • Tear resistance. The durability of SUTs is evalu- ated when impacted by another object or during attempts to tear. • Sterile integrity and shelf life. Af ter produc- tion, SUTs can be sterilized, undergoing exten- sive sterile validation and qualit y assurance. This should be verified for the given shelf life of the item. With these quality assurance procedures in place, companies can be certain that the risk of exposure due to faulty equipment is highly unlikely. Safeguarding HPAPI operations Patient safety from microbial contamination isn't the only risk that needs to be managed on manufacturing lines. Manufacturers also need to consider worker safety from toxic or highly potent APIs (HPAPIs). HPAPIs are harsh materials that can be high ly reactive. As the demand for these promising candi- dates has significantly increased, with market value expected to reach $34.97 billion by 2028, the industry must find ways to ensure operator safety when han- dling HPAPIs (6). Improper handling of these potent powders, as a result of negligence or human error, could lead to the presence of trace residues or even result in airborne particulates. Operator exposure to harsh HPAPI ma- terials could lead to adverse consequences, from skin sensitization and excessive hormone production to respiratory problems or even fatalities. As well as offering benefits when it comes to en- suring sterile integrity, SUTs offer a solution to help mitigate these risks, where no direct contact with the powder is necessary, as handling and transfer steps are completed using closed SUTs. In addition to uti- lizing SUT systems, a number of additional steps can be taken to further de-risk HPAPI manufacture (e.g., risk assessments, full compound characterization, mapping the production line, protective equipment, and personnel training). By following these steps and using SUTs, the risk to operators throughout HPAPI manufacture is signifi- cantly reduced. At the same time, these systems are also effective in protecting powders from the outside environment, as required through aseptic processing. Looking ahead SUTs offer a viable option for reducing risk in pharma- ceutical manufacturing, acting as a barrier between the operator and the product. This assures not only sterility but also personnel safety. As the demand for sterile processing increases and the industry contin- ues to move towards more potent materials, these SUT systems will become more commonplace in op- erational facilities and cleanroom environments. References 1. Global Market Estimates. Advanced Therapy Medic- inal Product (ATMP) Manufacturing Market. Market Report (updated on Oct. 13, 2023). 2. Future Market Insights. Aseptic Processing Market. Market Report (April 2023). 3. European Commission. Annex 1: Manufacture of Sterile Medicinal Products. EudraLex Volume 4, Aug. 22, 2022. 4. ECA Foundation. EU GMP Annex 1: Manufacture of Sterile Medicinal Products. GMP-compliance.org, Guidelines Detail (accessed July 17, 2023). 5. Borghgraef, C. EU GMP Annex 1 Revision: Manufac- ture of Sterile Medicinal Products—Summary and First Insights. Life Sciences Insights Blog, QbD Group, March 27, 2023. 6. Market Data Forecast. Global HPA PI Market Size, Share, Trends, COVID-19 Impact and Growth Analy- sis Report—Segmented by Type (Innovative HPA PIs and Generic HPAPIs), Synthesis (Biotech HPAPIs and Synthetic HPA PIs), T herapeutic Application and Re- gion—Industr y Forecast (2023 to 2028). Market Re- port (March 2023). ■ [Single-use technologies] offer a viable option for reducing risk in pharmaceutical manufacturing, acting as a barrier between the operator and the product.