Company spokesman Pascale Merle told in-PharmaTechnologist that media fill tests (MFT) used to check for microbial contamination during sterile operations can generate more than 15,000 samples that must be analysed by skilled technicians.
He said that, in contrast to available medias, bioMerieux’ TSB 3P range features a “groundbreaking” colouring system that changes from pink to yellow when microbes are detected.
Merle suggested that through this colour-change feature alone: “customers are going to save a lot of time during the reading step of thousands of units,” and that this will have significant cost implications.
He added that the two products, which contain either animal or vegetable derived peptones, have the “unique capacity to grow anaerobic bacteria that cannot usually be grown in this kind of media.”
Merle also said that bioMerieux’ R&D unit had worked with individual pharmaceutical customers and industry associations to check that the development concept driving the projected fitted with the drug industry’s requirements.
TSE free
bioMerieux also stressed that the medias, which meet with the US Food and Drug Administration’s (FDA) good manufacturing practice (GMP) guidelines, fit with the industry wide drive for prion-free products.
Since concerns about variant Creutzfeldt–Jakob disease (CJD) and transmissible spongiform encephalopathies (TSEs) emerged, the drug industry has sought to eliminate the prion proteins believed to cause this group of diseases from all production processes.
Merle explained that in response to this need, both medias in the TSB 3P range are guaranteed to be free of prions.
In a press statement, Alexandre Merieux, the firm’s corporate vice president of industrial microbiology, said that the ability to simulate sterile filling during microbiological testing is critical for the firm’s pharmaceutical industry customers.