Extract Technology, a UK-headquartered supplier of containment and aseptic systems for the pharmaceutical, healthcare, biotech and chemical markets, has supplied the National Bioproducts Institute (NBI), a manufacturer of a biological products, with a sterility test isolator for the company’s biotech facility in Pinetown, South Africa.
NBI contacted Extract Technology following a requirement to move to isolation technology to eliminate the risk of false positives by changing the company's testing methods from an open laminar air flow (LAF) to an enclosed sterility testing process for its microbiology laboratory.
The project, started in September 2013, was completed this month. Its scope included implementing a turnkey solution to improve sterility testing methods. This has been achieved through an isolator system that provides the client with a cost-effective alternative for sterility testing.
SteriPharm's aseptic isolator allows NBI operators to perform sterility testing with complete continuity and assurance of a grade A environment.
Increased protection is achieved by physical barrier technology, pressure differential and routine Vapour Phase Hydrogen Peroxide (VPHP) decontamination, which reduce contamination risks while ensuring product compliance.
Extract Technology says with more than 30 years of experience in manufacturing containment and aseptic systems the company has witnessed a significant shift to isolation technology from traditional open LAF testing in the pharmaceutical industry.
Dr Jeh-Han Omarjee, NBI Head of Microbiological Sciences, said: 'The SteriPhram isolator is user friendly and is easy to load for the decontamination and aseptic process testing of NBI’s products. The SteriPharm has improved the way in which sterility testing is now performed at NBI.'