Specialists for cleanroom
technology and laminar cabintets
technology and laminar cabintets
Testing and certification
Our accredited testing laboratory performs qualification measurements and validation of clean rooms, laboratories, operating theaters and other premises with controlled air cleanliness, as well as laminar airflow cabinets, biological safety cabinets, hoods, sterilizers, thermostats, incubators, refrigerators, HVAC systems, biological isolators and other equipment.
The LABOX accreditied testing laboratory is accedited for testing and measuring of cleanrooms and premises and equipment with controlled air cleanliness, air conditioning systems and components, microclimate, working environment, thermal processes, air filtration and laboratory equipment. The testing laboratory is accredited according by CAI (Czech Accreditation Institute) to EN ISO/IEC 17025.
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 | certification and 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), VDA, EN 12469, ISO 13485, EU GMP Anex 1, Volume 4 (2022), (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, centrifuges | 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, RPM, 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.
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
List of devices that we certify, qualify and validate:
- cleanrooms
- operation theaters
- sterlilizers
- hoods
- laminar airflow cabinets
- biological safety cabinets
- biological isolators
- premises with controlled air cleanliness
- sterilization tunnels
- thermostats
- freezers
- fridges, incubators
- chamber fridges
- chamber incubators
- stability chambers
- heating surfaces
- fermenters
- centrifuges
- filtration stations
- iodine filtration
- aerosol filtration
- heating, ventilation, and air conditioning systems (HVAC)
-
compressed air systems (cleanliness)
-
continuous monitoring systems
- decontamination systems
- cleanroom garmets and fabic (particle release)
- and many others