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20/30 Labs have the capability to undertake a range of testing designed to verify the quality of environmental conditions such as clean rooms and validation of sterility within their new 20,000 sq ft purpose built laboratories.

Cleanroom Validation

Areas for which environmental cleanliness is of paramount importance such as operating theatres and pharmaceutical manufacturing cleanrooms are subject to regular monitoring and validation activities.  Sampling of these areas in accordance with the requirements of BS EN ISO 14644 and BS EN ISO 14698, shall include determining effective filtration through air particle counting and testing for environmental flora through contact plates, settle plates and personnel monitoring.

ISO 14644-1 establishes the classification of air cleanliness in cleanrooms and controlled environments. Click here for our page on Airborne Particulates.

ISO 14698-1 describes the principles and basic methodology to assess and control biocontamination, where cleanroom technology is applied, in order that biocontamination in zones at risk can be monitored in a reproducible way and appropriate control measures can be selected. Click here for our page on Environmental Monitoring.

20/30 Labs Limited can perform the required analysis for cleanroom validation and the consumables and testing equipment required to perform the testing.

Bioburden Testing

Any decontamination or sterilisation process can only kill a finite number of organisms.  Bioburden testing is the enumeration and microbial characterisation of the population of viable microorganisms that are present on or in a medical device, component, raw material or sterile barrier packaging.

ISO 11737-1 specifies requirements and provides guidance for the enumeration and microbial characterisation of the population of viable microorganisms on or in a medical device, component, raw material or package. Click here for more information on how we can assess medical device bioburden.

Sterility Testing

A sterile medical device is one that is free of viable microorganisms. Re-useable medical devices that are sterilised prior to use are required to undergo routine sterility testing in accordance with the requirements of BS EN ISO 11737-2 and the European and International Pharmacopeia in order to verify the effectiveness of the sterilising process. Click here  for more information on our ISO 11737-2 testing.

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

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


Upcoming Events

  1. Basic Microbiology Study Day

    November 22 @ 11:00 am - 3:00 pm
  2. Basic Microbiology Study Day

    December 13 @ 11:00 am - 3:00 pm