State of the Art clean room technology

Testing and certification

Accredited testing laboratory No. 1313 is accredited by CAI (Czech Accreditation Institute), according EN ISO/IEC 17025.

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Measurements of clean rooms and facilities with controled air cleanness, air handling systems and components, microclimate, thermal processes and air filtering equipment

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AREAS

microclimate temperature, humidity, flow rate, barometric pressure, cleanliness level, etc..
air parameters measurement flow velocity, volume, pressure difference, pressure, temperature, duct air tightness, smoke air flow visualization test, etc.
efficiency measurement efficiency measurement of high efficiency air filters and iodine filters
thermal processes temperature, pressure
others CO2 concentration, conductivity of demineralized water, conductivity of purified water, revolutions (centrifuges)

 

DEVICES

clean rooms and laminar flow cabinets, microbiological safety cabinets, isolators, safety hoods qualification of clean rooms and laminar flow cabinets in accordance with EN ISO 14644:2015, CM/ResAP (2011), IES, FS209E, VYR-32, VYR-36 (SUKL), FDA Guidelines, cGMP (FDA), GMP Volume 4, (filter leakage test inc. installation leak, airborne particle count, cleanliness level, airflow velocity, airflow uniformity, recovery test, pressure difference test, flow visualization test, containment leak test, temperature and humidity test, etc.), including microbiological inspection of air cleanliness, regeneration time of rooms, cleanliness, tightness of air conduits and devices, measuring of filter devices efficiency, smoke air flow visualization test, etc.
surgeries, central sterilisation, PET centres, transfusion stations, chemists, laboratories the same as the qualification of clean rooms, including microbiological control and the concentration of anaesthesia gas
filter unit (including iodine filters) efficiency measurement of high efficiency air filters and iodine filters
moist heat and hot aire sterilizators, thermostats, incubators, refridgerators, freezers, desk and chamber validation of steam and hot-air sterilisers according to EN, ISO, VYR, further of freezers, thermostats, incubators (including CO2 incubators), refridgerators, chamber cooling plants, etc. Temperature map, stability study, heat penetration in material, verification of probes, steam quality, pressure, CO2 level, etc.
filtration stations and filter systems efficiency and fraction efficiency measuring, total efficiency of highly efficient filter devices, fraction efficiency of highly efficient filter devices, etc.
air-conditioning systems flow volume, pressure graph, flow velocity, flow graph, tightness of air conduits, etc.
clean room garment release particles from the surface of the clean room garment (useful also for testing of washing)

For further information and questions concerning validation, measurement and qualification will be answered by email or phone. Or contact us using the form and our staff will contact you as soon as possible.

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Our accredited laboratory cover all the parts of full qualification:

  • DQ Design Qualification
  • IQ Instalation Qualification
  • OQ Operational Qualification
  • PQ Process Qualification

Advantages of accredited testing laboratory:

Certainty of results

ensured by regular, independent, recertification of internationally recognized agency for accreditation of test laboratories

International(Worldwide) recognition of results

The LABOX accredited test laboratory is a member of the ILEC world association of accredited test laboratories

Sequence of accreditation chain

thanks to accreditation, the recognition of results is guaranteed within quality management with regard to integrated certified chain of seuquencies to national and international standards

 

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