🇨🇿 LABOX spol. s r.o. PL
Pharma & cosmeticsEnvironment
LABOX spol. s r.o. is a laboratory accredited by ČIA under number 1313 (Jirny, Czech Republic). Its accreditation scope covers 15 test methods in the following areas: Pharma & cosmetics, Environment. Test objects include: Thermal devices, Working environment, Aerosol filter elements, filters and filtering equipment, Air handling equipment and environment.
At a glance
- Accreditation number: ČIA 1313
- Methods in scope: 15
- Types of test objects: 13
- City: Jirny, Czech Republic
- Valid until: 13-05-2029
- Accreditation number
- 1313
- Accreditation body
- ČIA
- Address
- Brandýská 8, 250 90 Jirny
- City
- Jirny, Czech Republic
- Division
- Laboratorium Badawcze LABOX
- Valid until
- 13-05-2029
What this laboratory tests (13)
- Thermal devices — 2 methods
- Working environment — 2 methods
- Aerosol filter elements, filters and filtering equipment — 1 method
- Air handling equipment and environment — 1 method
- Air handling systems — 1 method
- Equipment and premises with controlled cleanliness of air and gases — 1 method
- Equipment and premises with laminar air flow — 1 method
- Equipment with laminar air flow — 1 method
- High efficiency particle air filter elements — 1 method
- High efficiency particle air filters and filter elements — 1 method
- Premises and equipment with controlled air cleanliness — 1 method
- Premises and equipment with controlled cleanliness of air, ventilated and air-conditioned rooms — 1 method
- Premises with controlled air cleanliness — 1 method
Certificate information
- Certificate date
- 13.05.2024
Accreditation scope — test methods (15)
| No. | Test object | Methodology / Parameters | Technique | Reference document | |
|---|---|---|---|---|---|
| Test methods | |||||
| 1 | Air handling equipment and environment | Determination of the mean airflow velocity and airflow volume in ducts and ventilation elements | SOP-Z001 (ČSN 12 4010; ČSN EN ISO 14644-3) | ||
| 2 | Equipment and premises with controlled cleanliness of air and gases | Measurements of aerosol particles in the air and gases based on the principle of light scattering | SOP-Z002 (ČSN EN ISO 14644-1; ČSN EN ISO 14644-3; IEST RP CC 006.2, kap. 6.3; FS 209 E; EU GMP Annex 1; VYR 32) | ||
| 3 | Equipment with laminar air flow | Measurement of deviations of streamlines in unidirectional air flow | SOP-Z003 (ČSN EN ISO 14644-3; IEST RP CC 006.2, kap. 6.5; EU GMP Annex 1; VYR 32) | ||
| 4 | Aerosol filter elements, filters and filtering equipment | Measurement of the overall filtration efficiency based on the principle of light scattering | SOP-Z004 (Směrnice ASI, část 3, příl. F) | ||
| 5 | High efficiency particle air filters and filter elements | HEPA filter integrity test | SOP-Z005 (ČSN EN ISO 14644-3; IEST RP CC 006.2, kap. 6.2; EU GMP Annex 1; VYR 32) | ||
| 6 | High efficiency particle air filter elements | HEPA filter integrity test of free HEPA filters | SOP-Z006 (IEST RP CC 006.2, kap. 6.2) | ||
| 7 | Premises and equipment with controlled air cleanliness | Determination of recovery time of a ventilated room | SOP-Z007 (ČSN EN ISO 14644-3; IEST RP CC 006.2, kap. 6.7; EU GMP Annex 1; VYR 32) | ||
| 8 | Premises and equipment with controlled cleanliness of air, ventilated and air-conditioned rooms | Determination of pressure pattern of a ventilated room | SOP-Z008 (ČSN EN ISO 14644-3; IEST RP CC 006.2, kap. 6.4; EU GMP Annex 1; VYR 32) | ||
| 9 | Working environment | Measurement of relative humidity | SOP-Z009 (ČSN EN ISO 7726) | ||
| 10 | Working environment | Measuring the resulting air temperature | SOP-Z010 (ČSN EN ISO 7726) | ||
| 11 | Thermal devices | Temperature measurement by a data logger | SOP-Z011 (ČSN EN 285+A1; ČSN EN ISO 17665-1; pokyn SÚKL DIS-15; EU GMP Annex 1; VYR 32) | ||
| 12 | Thermal devices | Pressure measurement by a data logger | SOP-Z012 (ČSN EN 285+A1; ČSN EN ISO 17665-1; EU GMP Annex 1; VYR 32) | ||
| 13 | Equipment and premises with laminar air flow | Determination of the average velocity and uniformity of airflow in a unidirectional air flow area | SOP-Z013 (ČSN EN ISO 14644-3; ČSN EN 12469; IEST RP CC 006.2, kap. 6.1; EU GMP Annex 1; VYR 32) | ||
| 14 | Premises with controlled air cleanliness | Auxiliary HEPA filter integrity test of clean room | SOP-Z014 (ČSN EN ISO 14644-3; IEST RP CC006.2, kap. 6.6; EU GMP Annex 1; VYR 32) | ||
| 15 | Air handling systems | Determination of air power and air reserve of the air handling system | SOP-Z015 (IEST RP CC 006.2, kap. 6.1) | ||
Reference standards (29)
EU GMP Annex 1
FS 209 E
IEST RP CC 006.2
IEST RP CC006.2
SOP-Z001
SOP-Z002
SOP-Z003
SOP-Z004
SOP-Z005
SOP-Z006
SOP-Z007
SOP-Z008
SOP-Z009
SOP-Z010
SOP-Z011
SOP-Z012
SOP-Z013
SOP-Z014
SOP-Z015
Směrnice ASI, část 3, příl. F
VYR 32
pokyn SÚKL DIS-15
ČSN 12 4010
ČSN EN 12469
ČSN EN 285+A1
ČSN EN ISO 14644-1
ČSN EN ISO 14644-3
ČSN EN ISO 17665-1
ČSN EN ISO 7726