Validation a top challenge when implementing single-use systems

posted by Phill Allen

June, 23rd, 2014

Company News Pharmaceutical Industry News

Validation and regulatory approval are among the top concerns of biomanufacturing professionals considering implementing single-use systems, according to a survey by Pharma IQ.
Validation a top challenge when implementing single-use systems
Disposable Solutions for Biomanufacturing 2014 Survey Results and Insight found that 60% of respondents saw validation as their biggest challenge with single-use systems.
Other key findings include:

  • 18% were concerned by retrofitting
  • 30% were concerned when it came to choosing and integrating disposable bioreactors
  • 35% were concerned with regulatory approval

The Pharma IQ online survey, which was conducted during October/November 2013, gauged the priorities and investment levels of biomanufacturing professionals currently weighing up the pros and cons of single-use systems.
“With single-use technology you have multiple challenges,” the report says.
These include:

  • Operators will have much more impact on the manufacturing process and, as such, there is more room for human error
  • Validation also becomes more difficult as single-use goods become more popular over time

How do you validate single-use systems?

The process by which industry validates a single-use system is currently unknown. This is partially down to the fact that there is an absence of “clear” regulatory guidance for the industry.
“To address this issue various organisations are looking at paths for approval,” explains the survey. “Multiple companies are looking into integration of single-use tools/devices into closed systems. Others are also looking at automaton of single-use systems, which will, over time, resolve some of their issues around validation.”
The survey generated feedback from stakeholders around the world, casting a spotlight on the perspectives of end-users.
Visit Pharma IQ for more information

Related reading:

TAGS: Biopharmaceutical, single-use systems, supply chain issues, Validation,


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Phill Allen

Managing Director

An in and outside the (bioprocess) box thinker, fluid management specialist Phill knows a thing or two about keeping pharma liquid logistics flowing.

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