The UK-based company are now offering cold filterable Tryptone Soya Broth (cfTSB) ready-prepared with Water for Injection (WFI) quality water, and available in 10, 20, 50 and 100 litre BioProcess Containers (BPCs).
The culture media provided by the firm are intended for use in media-fill trials in the pharmaceutical industry, whereby following the trial and filter-sterilisation process the medium is incubated for the recovery of contaminating bacteria, yeasts and moulds. This then reveals the level of microbiological contamination occurring in aseptic manufacture and can be used to identify problems in contamination control.
The company's cfTSB had previously been available only in dehydrated form, but this new, quality-certified, ready-to-use version in BPCs removes the media preparation stage which helps avoid potential contamination of the media and is more convenient than having to prepare solutions from scratch.
"Having the medium in pre-prepared containers makes the whole QA/QC procedure much easier," a spokesperson for the firm told In-PharmaTechnologist.com.
cfTSB is a highly nutritious, general purpose medium suitable for the cultivation of a wide range of bacteria, yeast and fungi. The firm's cfTSB medium complies with international regulations governing the formulation of media for aseptic process simulations, and carries the extra advantage of no heating requirement unlike other products.
The components of the cold filterable TSB have been specially screened and selected to ensure a highly filterable solution, and the BPCs are constructed form superior medical grade plastic and meet USP Class VI requirements.
Guidelines for the pharmaceutical industry recommend that media fill trials mimic the production process as closely as possible, which has been the impetus for Oxoid extending its range of products to meet this need.
"As process simulations play an increasingly important role in the manufacture of aseptic products, Oxoid cfTSB in read-to-use BPC containers allow pharmaceutical companies to simulate their aseptic processes as closely as possible, whilst meeting the requirement of international pharmacopoeia." said Oxoid pharmaceutical applications manager, Jennifer Laidlaw.
The product is now on the market, although no one form the company was available to comment on the price-tag or potential savings when compared to other medium products.