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20/30 Labs have a 20,000 sq ft purpose built laboratory, separated into different laboratory areas. Our highly trained staff have experience in testing a range of medical devices with a variety of different methods.

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Bioburden Testing

20/30 Labs test Bioburden in accordance with ISO 11737-1 “Sterilisation of medical devices: microbiological methods”.

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.  Bioburden tests estimate the total viable aerobic microorganisms on any surface of the item tested.

Bioburden testing of medical devices is a vital part of pre-sterilisation quality control monitoring because sterilisation processes, from steam sterilisation to irradiation, can only kill a finite number of organisms. Monitoring the bioburden therefore provides valuable information about the microbiological challenge presented to the sterilisation process.

Bioburden testing is used for:

  • Validation and routine monitoring of a sterilisation process
  • Assessing the efficacy of cleaning/decontamination process
  • Indicating potential problems in the production process that can lead to inadequate sterilisation
  • Monitoring non-sterile products that have a specified microbiological condition
  • Monitoring non-sterile products that have a shown microbiological state

Hospitals  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.

The levels of bioburden for products should not vary significantly to show that the decontamination process is being carried out consistently.  This helps ensure that effective sterilisation can take place.

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

Sterility Testing

20/30 Labs test Sterility in accordance with ISO 11737-2 “Sterilisation of medical devices: microbiological methods”.

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

ISO 11737 describes the sterility testing requiredd when validating a sterilisation process. Routine sterility testing is described in the European and International Pharmacopeia.

To safeguard Sterility Testing, all testing is carried out in a Class 5 cleanroom that is routinely monitored with Particulate Counts, Active Air Sampling, Contact and Settle Plates.  Our microbiologists are thoroughly trained in aseptic technique.



Other Services

We provide the complete package and also offer Environmental Monitoring and Airborne Particulate Counts.

Please contact us for further testing and information.

Hospital Analysis

A vast suite of standard and specialist analyses are available. Read More

Potable Water Testing

A range of tests available as required by the MODW and HTM 04-01. Read More

Pseudomonas Aeruginosa

The detection and enumeration of Pseudomonas aeruginosa according to HTM 04-01 and the MODW. Read More

Legionella Testing

Accredited to ISO 11731-2:2008 to carry out detection and enumeration of Legionella. Read More

Get in Touch

If you would like to speak to someone regarding sample analysis, testing scope or advice, please do not hesitate to contact us: