Single-Use Versus Stainless Steel in Biopharmaceutical Processing
The introduction of single-use systems in the biopharmaceutical industry creates an alternative to traditional stainless steel medical equipment by offering exceptional quality, safety benefits and lower cost expenditures. As single-use systems become more and more mainstream, there is an increasing demand for materials of the highest caliber to ensure safety and reliability. Solvay offers a broad portfolio of high-performance polymers for single-use technology that provides quality assurance, flexible production and reduced capital investment.
Until recent years, stainless steel has been the preferred material for medical and pharmaceutical equipment. Today’s biopharmaceutical industry is using specialty polymers, such as PPSU, PEI and PSU, with unmatched chemical and mechanical properties to build advanced single-use systems with more simplified production than its stainless steel counterparts. For over 30 years, Solvay polymer technology has contributed to advances in the medical industry and now those same technological advances are being implemented in single-use systems. By incorporating Solvay specialty polymers, single-use systems now provide the biopharmaceutical industry with reliable, high-performance polymers that save time, money and energy.
Single-use technology made with high-performance polymers allows for easier and more flexible production than stainless steel. Single-use systems require significantly less time, energy, labor, resources and capital. In addition, the manufacturing of stainless steel requires sanitation processing that involves extensive amounts of power and raw materials. Lastly, stainless steel operations require significantly greater capital investments than single-use systems.
Quicker Turnaround to Market
The global shortage of biopharmaceuticals, the need for personalized medicine and the shift towards contract manufacturing are just a few of the reasons why biopharmaceutical manufacturers to seek new means to increase both speed to market and lower costs. The planning, construction and implementation of traditional stainless steel biopharmaceutical plants can take anywhere from six months to two years. In addition, these traditional biopharma plants are not very efficient in terms of quickly retooling or making product line changes. Biopharmaceutical plants that rely more heavily on single-use technology are exempt from extensive disassembly and clean up. Single-use technology is constructed to accommodate to needed operational changes easily. The flexibility of single-use systems allows for small batch production, formulation of a more comprehensive portfolio of drugs and the ability to quickly adjust to the changes needed from drugs undergoing clinical trials.
Reduced Cleaning Requirements
One of the most significant differences between the manufacturing operations of single-use systems and that of traditional stainless steel is the sanitation process. Stainless steel operations require extensive cleaning-in-place (CIP) and sterilization-in-place (SIP). Even after extensive cleaning validation, stainless steel manufacturing poses the risk of cross-contamination between batches. The repeated steam cleaning used stainless steel components must undergo utilize additional time and resources that single-use systems do not require. Single-use systems solely depend on gamma irradiation to sterilize their materials. Solvay specialty polymers are gamma irradiation compatible up to 50kGY to provide single-use technology with more easily-sterilized materials than stainless steel.
Lower Capital Investment
With demand for biopharmaceuticals increasing, manufacturers are continuously striving for new opportunities to reduce initial capital investments and development costs. Solvay contributes strong, chemically inert specialty polymers to single-use systems that allow for more cost-effective operations. Single-use systems enable biopharmaceutical manufacturers to use small-scale production facilities to produce smaller drug batches and ultimately reduce the company’s capital investment for startup pharmaceuticals.
In response to the demand for biopharmaceutical production with greater flexibility and reliability, the industry is incorporating single-use technology as an alternative to stainless steel. Additionally, single-use systems offer simpler production, reduced need for cleaning requirements and low capital expenditures than stainless steel operations allow. Solvay specialty polymers are more versatile materials than stainless steel and make single-use systems possible with advanced chemical and mechanical properties and minimal to no risk of cross-contamination.