Quality assurance considerations in single-use manufacturing
How, as a manufacturer of single-use systems, we support biopharmaceutical companies in implementing single-use technologies that reduce contamination risk, improve resource efficiency and lower labour and energy costs.
Today the single-use manufacturer is faced with unique challenges in fulfilling the expectations of its biopharmaceutical customers, and the regulators who are applying ever-expanding controls over this emerging industry. Many of these challenges directly impact the quality and regulatory compliance organisations within the single-use manufacturing organisation. The attached article provides a discussion of the quality and regulatory foundations upon which VWRs 'best-in-class' single-use manufacturing is based. The considerations include, but are not limited to:
- Cleanroom certification and contamination control
- Environmental monitoring
- Sterility and sterile-barrier packaging validation