In the manufacture of biologicals single-use disposable flexible vessels are commonly used as bioreactors, mixers and sterile fill stations. To guarantee the vessels are of the quality needed to ensure process integrity, they must be proven free from biological contamination and free of leaks that could be an ingress route for contaminants such as bacteria. The traditional pressure decay method has significant limitations, so ATMI has created a reliable and repeatable method involving pressurising the vessel with helium instead of air. By using this method, defects as small as 10µm can be easily detected.
Tiny holes in the vessel walls or seals can provide an ingress route for contaminants
Proving that disposable plastic vessels are leak-free has become a critical requirement for those involved in the manufacture of biologicals. Engineers at ATMI LifeSciences have developed a method using helium to improve the integrity testing for such vessels.
There has been a trend in the past few years for the biopharmaceutical manufacturing sector to use disposable plastic vessels in place of traditional steel and glass containers. Employing single-use vessels can offer technical, operational and economic advantages by reducing the risk of cross-contamination and eliminating the need for time-consuming and expensive cleaning and validation procedures.
Single-use flexible vessels were first used to store GMP materials, but now they are commonly used as bioreactors, mixers and even sterile fill stations. The use of these vessels for storage applications was rapidly accepted in the industry over the past decade, but they have really gained significant market penetration in biomanufacturing only in the past three years or so....
This is a small extract of the full article which is available ONLY to subscribers. Subscribers sign-in (top right) to read the article.
Subscribe now to Cleanroom Technology