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20/30 Labs offer the services below for the validation of cleanrooms or areas in which the environment must be controlled in accordance with ISO 14644.

Particle-Counter

Particulate Count

20/30 Labs will come to site to conduct particulate counts to quantify the size and number of particles in the air to classify your cleanroom according to ISO 14644. Cleanrooms must be routinely monitored for airborne particles to determine levels of airborne contamination, and thereby assess the suitability of a work area for medical device processing. ISO 14644 establishes the classification of air cleanliness in cleanrooms and controlled environments. Occupancy of the room is recorded whilst particulate counts are taken.  Our particle counters are regularly serviced and UKAS-calibrated to ensure optimum performance and confidence in results.
To help ensure that cleanrooms are not contaminated from adjacent, less clean, spaces cleanrooms should be maintained at a higher static pressure than the adjacent spaces.  The room is usually at a positive pressure over the surrounding area so as to ensure that any air leakage is removed from the room into the local environment and not the reverse.
20/30 Labs will measure the pressure differential between the cleanroom and adjacent areas to demonstrate conformance. 20/30 Labs only use UKAS calibrated pressure differential meters.

Pressure Differentials

To help ensure that cleanrooms are not contaminated from adjacent, less clean, spaces cleanrooms should be maintained at a higher static pressure than the adjacent spaces.  The room is usually at a positive pressure over the surrounding area so as to ensure that any air leakage is removed from the room into the local environment and not the reverse.
20/30 Labs will measure the pressure differential between the cleanroom and adjacent areas to demonstrate conformance. 20/30 Labs only use UKAS calibrated pressure differential meters.

Pressure-Differentials

Anemometer

Air Flow

Using regularly serviced and UKAS-calibrated anemometers, we will measure the air flow in your cleanroom.  Using the measurement of air flow from vents and air ducts, the number of air changes per hour will also be calculated.   This will be a useful indicator to demonstrate that your air handling system is performing as required, thereby ensuring that your cleanroom environment is maintained.

Other Services

We provide the complete package and also offer Environmental Monitoring and Bioburden and Sterility testing.

Please contact us for further testing and information.

Cleanroom

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:


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