Bioburden Testing
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 prove that the requirements are 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, Ph. Eur. or USP. Bioburden testing of components can show
the use of adequate control measures 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. All our methods are UKAS accredited
and based on the Ph. Eur. The Medical Devices Agency advises
on the microbiological safety aspects of medical components.
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 Ph. Eur. 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 Pharmaceuticals website
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