Sterility

A sterilisation process should kill all microbiological contaminants on a medical device, thereby transforming non-sterile products into sterile ones. Sterility testing is used to verify or assess the effectiveness of this process.

In order to ensure accuracy of results and to prevent the introduction of external contaminants, all sterility testing is carried out in a Class 5 cleanroom that is routinely monitored with particulate counts, active air sampling, contact and settle plates, and all of our laboratory analysts are thoroughly trained in aseptic technique.

Bioburden

Bioburden testing is the enumeration and microbial characterisation of the population of viable microorganisms present on a medical device, component, raw material, or sterile barrier packaging. Sterilisation processes, from steam sterilisation to irradiation, can only kill a finite number of organisms, therefore monitoring the bioburden provides valuable information about the microbiological challenge presented to the sterilisation process.

Sterile Services Departments (SSD):

We offer bioburden testing of reusable surgical instruments for hospital Sterile Services departments, which need to demonstrate that their decontamination processes are effective.

A selection of instruments processed by the Sterile Services department should be routinely tested post wash-disinfect, but prior to sterilisation. Instruments can be grouped into “families” and one instrument from each family should be regularly tested for bioburden.  Selecting instruments such as those with hinges, box joints, serrated edges or multiple components tests the worst-case instruments which provide the greatest challenge to the decontamination process.

If the decontamination process is being carried out consistently then the levels of bioburden for families of instruments should not vary significantly between cycles of testing.

Industry:

We also offer bioburden testing for manufacturers of medical devices who need to carry out routine testing on representative samples of their products.  A manufacturer may choose, for example, to send five samples of each product for testing on a regular basis. This would confirm that the manufacturing and packing processes are in control.

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