Helium Integrity Testing

By Richard Bhella, Global PM, Single-Use Storage & Delivery Technologies, ATMI

Single-use manufacturing technologies have made significant inroads into the bioprocessing market in recent years, as companies recognize the advantages they offer in terms of saving time and money, and reducing the risks of contamination from one batch to another. In 2011 the global market for single-use disposable technologies was $650 million, of which $150 million was in cGMP manufacturing. The implementation of these technologies is expected to continue growing rapidly, quadrupling the total market size within 5 years. The bulk of this growth will be in cGMP manufacturing.

When introducing single-use technologies, the integrity of the system is crucial. Holes or defects in the bag, tubing, or other subcomponents can compromise product quality, resulting in significant financial loss. Dripping leaks are usually obvious, and potentially recoverable by rework, for example. However, smaller defects can also exist that are not so readily apparent, and can allow ingress of microbes that compromise product sterility in a way that may not be detected until much further downstream, by which time it is often too late for rework.

In upstream processes, there is a general perception that many non-obvious leaks are manageable. Most of the liquids at this stage are media or buffer solutions, which are of comparatively low value and can be readily recovered by sterile filtration. However, for bioreactors themselves, and for containers used to store product further downstream, the potential problems are significant. If the batch becomes contaminated as a result of microbial ingress, it is very difficult to decontaminate it. In a worst-case scenario, the contamination may not be obvious before the product leaves the factory, and unsafe products might even reach patients. This could potentially be catastrophic, both financially and in terms of a company's reputation. It is thus essential to be certain that the containers and bioreactors do not have defects that might allow microbial contamination.

About The Author
Richard Bhella came to ATMI in June 2005 with a strong background in technical sales and marketing within the chemicals industry. Richard is currently the Global Product Manager of Single-Use Storage and Delivery Technologies for ATMI LifeSciences. In this role, he is responsible for the global marketing for all of ATMI's ultra-clean single-use disposable storage technologies. Prior to his current position, Richard came to ATMI in the role of Applications Manager and was promoted into Director of Applications. His extensive background has allowed him to apply his exceptional knowledge in analytical and polymer chemistry, as well as semiconductor, pharmaceutical and biopharmaceutical technologies.

Richard studied at Kingston University, where he obtained a Bachelors degree in Applied Chemistry. In addition to his educational background and 20 plus years experience in the chemical, semiconductor, pharmaceutical and biotechnology sectors, Richard is well versed in the use of Six Sigma Methodologies for Product Development and Applications Studies ("Design for Six Sigma") and is a Six Sigma Black Belt.