Single-Use Technology

30 September 2021 - 30 September 2021
The ISPE Disposable (Single-Use) Community of Practice (CoP) is organizing a round table on Monday 30 September to discuss the "Single-Use Supply Shortage Crisis". The goal will be to share good and bad experiences, to identify bottlenecks and...
Features

Risk management is pervasive throughout the biopharmaceutical industry. It is an important factor during the implementation of new equipment or procedures into an operation. Likewise, risk management is also key when assessing the impact of changes. When doing a root cause analysis, evaluation of the risks becomes central to define the potential solutions to the problem analyzed and to...

Guidance Documents
09 November 2018
News & Press Releases
ISPE announced the release of their latest Guide, ISPE Good Practice Guide: Single-Use Technology. This Guide provides a roadmap for efficient implementation of single-use technology (SUT) with minimum disruptions to existing operations. "Single-use...
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Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly reducing the risk of contamination in manufacturing equipment. The implementation of single-use technology into a process requires a well-defined plan that minimizes surprises during the later stages of implementation.