How to Ensure Integrity and Sterility of Single-Use Assemblies for Manufacturing

By on July 15, 2013
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How to Ensure Integrity and Sterility of Single-Use Assemblies for Manufacturing.
Starts July 15th, 2013.

Single-use systems have many clear advantages, however, one challenge is ensuring the integrity of these plastic bags and components. Microscopic breaches of integrity, even those that cannot be seen, can allow microbial ingress. Possible breaches extend beyond just the bags, so the entire single-use assembly including tubing, connectors, seals, etc. must be tested for integrity to ensure against potential contamination problems.

To address integrity concerns, companies that manufacture single-use components will typically conduct a visual inspection and perform pressure decay testing. Pressure decay testing is the industry standard for validating single-use bag integrity, however there are limitations to the level of assurance this testing can provide.

ATMI’s HIT™ system addresses both the challenge of testing complete single-use assemblies and ensuring bag integrity at point-of-use. The system was first launched in 2010 as an in-house add-on testing service for the company’s 2-D bioprocess bags and manifolds, and now the HIT system has evolved to the next level. It is offered in multiple formats: either as add-on testing for the full line of ATMI 2-D and 3-D vessels up to 200L, or as a point-of-use-system to customers for implementation in their own facilities.

This week’s session is hosted by Carla Conant, Global Product Manager, ATMI LifeSciences. Carla Conant joined ATMI LifeSciences in May of 2013 as a Global Product Manager focused on the Integrity® suite of products and technologies. She brings over a decade of experience in the biopharmaceutical industry and single-use plastics to this role, complemented by a rich background of brand management, promotion and product development. Carla holds an MBA in Finance and a double Bachelor in International Business & Economics and Spanish.

Please take advantage of the opportunity to ask Carla a question and participate in a lively discussion about testing the integrity of single use systems!

For more information, please see our blog titled “Ensuring Integrity and Sterility of Single-Use Assemblies

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