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

Sponsored by: ATMI LifeSciences
Session ended: July 19th, 2013
Expert: Carla Conant, Global Product Manager, ATMI LifeSciences

Introduction

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.


Questions & Answers

Can you explain the difference between pressure decay testing and what the HIT system offers?

To address integrity concerns, companies that manufacture single-use components will typically conduct a visual inspection as well as perform pressure decay testing. Pressure decay testing is the industry standard for validating single-use component integrity, however there are limitations to the level of assurance this testing can provide. Pressure decay testing measures a drop in pressure […]» Read More

Down to what level of contamination are you able to test?

The HIT™ System tests for defects in single-use assemblies which could potentially lead to contamination. The HIT™ System uses a control unit that houses highly-sensitive mass spectrometry equipment, and a test chamber with a fully customizable containment rack. The single use assembly to be tested is put into the test chamber and connected to service […]» Read More

If you want to use this at your facility to test single use systems on site, how easy is it to use? How much training is required?

The Point-Of-Use variant of ATMI’s HIT system has been designed with ease of use foremost in mind. Before first use (i.e. during startup), and periodically thereafter, the system does have to be configured for the specific single-use assembly in question by an ATMI technician (a somewhat advance process involving recipe optimization and detector calibration). Once […]» Read More