Single-Use Systems: Why the New Kids on the Block Need to Prove Themselves
ISPE 2015 Annual Meeting attendees gained a number of innovative solutions related to single-use technology during the session: “Single-Use Technology: The Advances of a Flexible Technology in a Structured Environment.” The session focused on methods of reducing risk and streamlining the implementation of Single-Use Systems.
Christopher Smalley, Director of Sterile and Validation CoE Global Technical Operations at Merck & Co., compelled attendees to embrace the new technology despite its potential challenges. Smalley started by pointing out the many benefits of Single-Use Systems, including:
- Greater assurance of sterility
- Reduced validation & qualification times
- Increased facility capacity
- Improved portability and scalability
- Diminished risk of cross contamination
Smalley’s question: Why are we still so hesitant to implement a technology with so many obvious benefits?
The answer: We work in a risk-adverse industry, where unknown elements become risks and we are suspicious of the “new and innovative.” We are comfortable with what we have, and oftentimes innovations come with indefinite expectations.
So how do we overcome this?
According to Smalley, it starts with good engineering practices. It’s important to implement user requirements and provide credible specifications for all components. We need to meet user requirements with intelligent component sourcing and management strategy. We also need to “control what we can, and plan for what we can’t.” This includes construction materials, assembly operations, connection design, packaging, and shipping.
But even if we’re planning ahead and using the best possible practices, implementing Single-Use technology can still be risky – because we don’t have solid industry best practices to refer to.
While many organizations including ISPE are working to develop those best practices, it’s been a long process: a process Chris Smalley says you can help speed along. By joining these teams or just making sure your company is represented, you can help make Single-Use Systems easier for everyone.