Specialty Polymers for Single Use Systems – Enabling Technologies that Improve or Sustain the Quality of Life
The developers and manufacturers of immunotherapies are employing innovative bioprocessing technologies and production technologies from the earliest, small-quantity trial stages to full-scale commercialization. The demands for quality, purity, scalability, flexibility and affordability are exceptional.
Single-use technology is uniquely suited to address these complex and multiple demands. Equipment changeover of plastic single-use equipment and components can be accomplished in hours instead of days—a fraction of the time and cost required for reusable, stainless steel equipment. Single-use eliminates the concerns about purity and contamination in reuse, as well as the water consumption, time and costs required for cleaning and cleaning validation.
Post Gamma Integrity
To ensure a pure environment, single-use equipment must be sterilized before use, and gamma irradiation is the increasingly preferred method. With some plastics, though, gamma sterilization causes concern about leachables and extractables, which can affect the purity and performance of biomaterials in processing and in patients.
At Solvay, we are committed to providing customers with post-gamma testing documentation for our broad portfolio of high-performance polymers that demonstrates the absence of leachables and extractables and retention of mechanical properties after gamma irradiation.
Key Benefits of our Portfolio
- Diverse range of gamma stable, medical-grade polymers
- ISO 17025 testing laboratories
- ISO 10993, USP Class VI, and post-gamma USP Class VI testing
- Post-gamma radiation mechanical performance test data available
- BPOG test protocols for worst case scenario
- High/low temperature stability and strong mechanical properties
- Less swelling than silicon or polyethylene
- Low protein and small molecule absorption
- Good flow characteristics
- Hydrophobic and hydrophilic materials for filtration