While stainless steel is the more conservative selection and has a long-term presence on the market, single-use technology is a newer, more innovative solution. The biopharmaceutical industry is adopting single-use systems to conserve time, capital and energy and is using specialty polymers, such as ULDPE, and EVA for their chemical and mechanical properties to enhance today’s single-use systems.
Where Single-Use Technology is Used
Today, there exists a greater global demand for pharmaceuticals and personalized medicine. In response to these demands, single-use technology is broadening the scope of manufacturing applications to allow for flexible assembly, small batch production and formulation of a more diverse portfolio of drugs. Single-use systems are designed to accommodate the needed operational changes with ease and resilience.
- The Shift towards Single-Use
The main advantage of using single-use systems in the biological pharmaceutical industry is that:
- Improved Sterility Assurance
- Economical Manufacturing
- Faster Turnaround to Market
The key drivers for single-use systems in the biopharmaceutical industry are the same today as they were several years ago. Single-use technology contributes to improved sterility assurance, more economical manufacturing and faster turnaround to market beyond what its stainless steel counterparts are capable of. As single-use technology moves toward commercial-scale production, the demand for materials of the highest caliber increases. The superior chemical resistance, strength, biocompatibility properties and scalability of ZISTBAG provide single-use technology with the performance capabilities needed to continue developing the biopharmaceutical market.
Improved Sterility Assurance
Cleaning validation is the most significant difference between single-use systems and stainless steel counterparts. Single-use technology eliminates the need for cleaning-in-place (CIP) and sterilization-in-place (SIP) and the risk of cross-contamination. As opposed to the repeated steam cleaning required by stainless steel, single-use systems undergo gamma irradiation to sterilize their materials and eliminates excess usage of time and resources.
Single-use systems allow for greater sterility assurance, lower capital investments and faster production rates. 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. Zist Bag Polymer broad portfolio of specialty polymers offer the advanced chemical and mechanical properties needed to do so.
Economical Manufacturing
In response to the increasing need for biopharmaceuticals, manufacturers are implementing single-use systems to decrease capital investments and operational costs. Zist Bag Polymer contributes to these systems with strong, chemically inert specialty polymers that allow for more cost-effective operations. Additionally, single-use systems enable manufacturers to use small-scale production facilities for smaller drug batches that ultimately reduce the company’s capital investment costs.
Faster Turnaround to Market
Whereas stainless steel production lines can take years to set up and months to switch products, single-use technology allows biopharmaceutical plants to reduce assembly and market turnover time down to a matter of days. Single-use technology eliminates the need for extensive cleaning validation and disassembly– two lengthy processes required when working with stainless steel. Additionally, single-use systems demand less power and raw materials and increase productivity as they demand less energy, labor, resources and capital.
- Stainless steel production lines can take years to set up and months to switch products, single-use technology allows biopharmaceutical plants to reduce assembly and market turnover time down to a matter of days.
- Single-use technology eliminates the need for extensive cleaning validation and disassembly– two lengthy processes required when working with stainless steel.
- Less energy, labor, resources and capital.
- Increase productivity.
