By John Briggs, ASQ, CQA, Quality Assurance Manager - ASI
During the last six years, single-use systems and devices have emerged as key agents in the biopharmaceutical landscape. Single-use solutions have revolutionized the Pharmaceutical and Biopharmaceutical industry due to their effectiveness in reducing the risks of contamination and allowing faster changeovers. These advantages, coupled with the significantly reduced time and costs required to establish a new manufacturing facility, have made single-use systems the products of the future.
Single-use products have pushed beyond an early-stage technology, and it is likely that the popularity of these devices will continue to rise over the next few years. Therefore, it is becoming increasingly important to view single-use system suppliers, not only in the context of ‘can they make the disposable,’ but also from the perspective of ‘does the single-use system supplier maintain strong quality oversight to support their product from a control process and ensure regulatory compliance.’ The recent 9th Annual Report and Survey of Biopharmaceutical Manufacturers indicates that end-users of single-use devices rate product quality at the top of their supplier attributes list. The manufacture of high-quality devices requires single-use system suppliers to minimize risk and ensure safety, traceability, and compliance at every stage of production. To minimize risk, single-use system suppliers must control and document each production step from raw materials and assembly to final test, packaging, and sterilization.