3 Ways Single-Use Technology is Advancing Biopharmaceuticals
Today’s rapidly expanding biopharmaceutical industry is integrating single-use bioprocessing manufacturing to fulfill the global demand for greater production efficiency and effectiveness. Single-use technology allows for increased productivity, less energy demand, reduced capital investment and the elimination of cleaning-in-place (CIP) and sterilization-in-place (SIP). Single-use systems are made possible with high-performance plastics. Solvay supplies the biopharmaceutical industry with a diverse portfolio of gamma-stable medical-grade polymers that offer strong mechanical properties, temperature stability, chemical inertness and chemical resistance.
With the need for simplified biopharmaceutical processing continually growing, many manufacturers are making the switch from reusable stainless steel processing systems to single-use systems. These systems are composed of specialty polymers with unmatched chemical and mechanical properties such as PPSU, PSU and PEEK to support more dynamic, productive operations. Stainless steel manufacturing involves excessive cleaning requirements, lengthy production time and higher risks of cross-contamination than what single-use technology allows for. In today’s market, single-use technology is put into effect to save time, money and energy.
How Single-Use Technology is Advancing Biopharmaceutical Processing:
One of the many benefits of Solvay specialty polymers for single-use technology is their compatibility with the preferred sterilization method of single-use equipment, gamma irradiation. Solvay has tested its polymers under United States Pharmacopeia (USP) Class VI testing standards before and following gamma irradiation. This form of cleaning validation is a low-risk and straightforward method for ensuring sterilization, whereas stainless steel operations must undergo extensive cleaning validation– cleaning-in-place and sterilization-in-place that use up valuable time and resources. Additionally, gamma irradiation and single-use systems can eliminate the risk of product cross-contamination that reusable stainless steel systems can produce.
Agile Biopharma Production Lines
One of the most significant benefits of single-use technology is its ability to adjust easily to operational changes that allow for small-scale production facilities and small batch production which allows the formulation of a broad portfolio of drugs. Single-use technology involves a simplified and more flexible production that requires significantly less time, energy, labor, resources and capital. With no need for cleaning validation, single-use systems consume substantially less power and raw materials, like chemicals and water, to effectively sterilize their equipment. In terms of time, traditional biopharmaceutical processing using stainless steel typically has a market turnover time anywhere from six months to two years. Single-use systems take days to weeks to make it to market as they are exempt from extensive cleanup and disassembly.
Cost-Effective Biopharmaceutical Manufacturing
Biopharmaceutical producers are continually seeking new manufacturing solutions to reduce initial capital investments and development costs. Not only do single-use systems dramatically scale back a number of traditional manufacturing expenses, like the costs of cleaning validation and raw materials, but they also supply greater production flexibility that allows manufacturers to create smaller, more specialized batches without raising capital expenditures.
The biopharmaceutical industry is shifting to single-use technology to provide greater production flexibility and reliability. Single-use systems respond to the global demand for advanced, easier biopharmaceutical manufacturing by providing simplified processing, easier sterilization and lower capital investment. Single-use technology is made possible with Solvay’s broad portfolio of chemically inert, temperature resistant specialty plastics.