National Bioproducts Institute (NBI), a manufacturer of a wide range of biological products awarded Extract Technology with the contract to supply a Sterility Test Isolator for the company’s Biotech facility based in Pinetown, South Africa.
NBI contacted Extract following the company’s requirement to move to Isolation Technology to eliminate the risk of false positives by changing their testing methods from an open LAF to an enclosed Sterility Testing process for their microbiology laboratory.
The project was started in September 2013 and was completed in July 2014. Its scope included implementing a turnkey solution to improve Sterility Testing methods achieved through a user friendly isolator system that provides the client with a cost effective alternative for sterility testing.
Extract’s new low cost standard aseptic isolator, SteriPharm provides NBI with a suitable solution for 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, reducing the possibility of any contamination risks and at the same time ensuring product compliance.
With over 30 years of experience in manufacturing containment and aseptic system, Extract Technology have witnessed a significant shift to the adoption of isolation technology over traditional open LAF testing since the advantages demonstrated in aseptic processing for the pharmaceutical industry are evident.
Dr Jeh-Han Omarjee, NBI Head Microbiological Sciences, commented “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. We are pleased with the implementation of the SteriPharm isolator and the service provided by Extract Technology.
Extract worked closely with NBI to ensure the clients detailed and concise specifications were met, resulting with the supply of this ergonomically friendly Sterility Testing solution.