Bioburden testing is intended to estimate the number of micro-organisms present on merchandise before sterilisation. Using validated methods, in accordance with ISO 11737 bioburden enumeration shows process control and alarms manufacturers if and when an issue arises. Where a verified method dAAS not exist, MVS can create a technique most appropriate to your product. The identification of colonies present can assist in providing insight into where any possible problems may lie and guidance on possible solutions is easily available. Additional typing of microbiological species can be obtained upon request. Formal and informal consultancy can be offered to make sure that product is produced, cleaned and packed using best practise at all times, ultimately resulting in assurance that product is fit for purpose.
Testing single use and reusable medical devices, water and detergents, to include procedure validation, using a variety of techniques such as: Membrane filtration, direct inoculation, tests for specified organisms, TAMC/TYMC into the harmonised pharmacopeia. The membrane can then be aseptically Transferred to the medium. The membrane filtration method is recommended for adapting Huge volumes of test substance or when the test substance comprises substances Which can inhibit growth of microorganisms, like antibiotics. This stage, is it reasonable to assume then that because of the non-selective character of TVC analysis, coupled with the delineation between environmental and what might be contaminants of human significance, TVC tests might be useful indicators for system security. Unfortunately, research indicates a poor correlation between the organisms recovered by a TVC test plus a selective test employed for the identification of pathogens in human health. It is probable, as opposed to potential, that should a TVC and discerning test be used for the analysis of the same sample, the discerning test may very well test negative for the goal organism/pathogen although the TVC evaluation reports a general microbial count.
The bioburden testing can be performed with one of 2 methods, membrane filtration or direct inoculation. For immediate inoculation, the test Substance is only aseptically added to inoculate the media. For membrane Filtration, the test substance is passed through a size exclusion membrane Capable of keeping microorganisms. This Leads us onto ‘if’ it might be appropriate to bring a TVC, As stated earlier, where TVC testing is recommended by legislation or advice then it would be wise to stick to this for compliance; thus, ensuring duty-of-care responsibilities are appropriately discharged and water system consumers are adequately protected in the point of care/use so far as reasonably practicable.