ECLIPSE - PHARMACEUTICAL TESTING SERVICES |
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Microbiological Testing Pharmaceuticals Efficacy Testing Our laboratories at Ely have specialised facilities for handling pharmaceutical testing, including:
Pharmaceutical Preservative Efficacy Testing Pharmaceutical preparations with inadequate intrinsic anti-microbial activity are likely to have anti-microbial preservatives added. These additives are designed to prevent proliferation or limit contamination by micro-organisms. The preservative qualities of the preparation are checked during development by performance of an Efficacy of Anti-microbial Preservation Test. During the development of pharmaceutical preparations, it is necessary to prove that the anti-microbial activity of the preparation is adequate to prevent the problems that could occur from microbial contamination or proliferation during storage. The BP, EP and USP detail guidance on the performance and interpretation of preservative efficacy testing. Our in-house method, which is UKAS accredited, has been developed according to the EP. We can, however, perform testing according to the BP or USP. The types of preparations for testing range from powders through to liquids and include topical creams, oral syrups and parenteral solutions. Bioassays are used for the analysis of certain antibiotics and vitamins by either turbidimetric or agar diffusion techniques. The turbidimetric assays have largely been developed in-house for vitamin analysis and are applicable to a wide range of matrices, containing either supplemented or natural forms. Products tested include foods, soft drinks, multi-vitamin tablets and pharmaceutical preparations. The agar diffusion technique is primarily for certain antibiotics used within the animal health industry, although other standard procedures, listed within the various pharmacopoeias, can be performed.
Products or components used in the pharmaceutical or medical field require control of microbial levels during processing and handling. Bioburden or microbial limit testing on these products is used to verify that the requirements are being met. Microbial limit testing of raw material as well as finished pharmaceutical products can help to determine whether the product complies with the requirements of the BP, EP or USP. Bioburden testing of components can verifies that adequate control measures have been employed during the preparation and handling. The satisfactory criteria for the microbial quality of pharmaceutical preparations are specified in the relevant Pharmacopoeia; guidelines are also given for the carrying out of testing. The Medical Devices Agency advises on the microbiological safety aspects of medical components. All of our methods are UKAS accredited and based on the EP. Pharmaceutical product types range from powder to oil and include creams, oral syrups and capsules – in fact anything that is included in categories 2 - 4B of the EP. Components range from small medical implants to devices used for the delivery of pharmaceutical products and may be composed of metal or plastic. Click here for Bioburden Information on our main web site Disinfectants and antiseptics should be assessed for their efficacy according to their use and application. BS/EN methods have been developed so as to standardise testing conditions and to yield a quantitative result on the performance of a particular product tested under standard conditions. Eclipse advises on the best regime of testing, helps with specific testing needs and then performs the testing as relevant. Methods used in our laboratories include: BSEN 1040 :1997
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