🇨🇿 ITEST plus, s.r.o. PL
MicrobiologyPharma & cosmetics
ITEST plus, s.r.o. is a laboratory accredited by ČIA under number 1678 (Hradec Králové, Czech Republic). Its accreditation scope covers 9 test methods in the following areas: Microbiology, Pharma & cosmetics. Test objects include: Medical devices, Cleanrooms. Most frequently used techniques: by culture, Gel method, Kinetic turbidimetric method.
At a glance
- Accreditation number: ČIA 1678
- Methods in scope: 9
- Types of test objects: 2
- Techniques used: 3
- City: Hradec Králové, Czech Republic
- Valid until: 27-02-2028
- Accreditation number
- 1678
- Accreditation body
- ČIA
- Address
- Kladská 1032/44c, Slezské Předměstí, 500 03 Hradec Králové
- City
- Hradec Králové, Czech Republic
- Division
- Laboratorium Kontrolne ITEST plus
- Valid until
- 27-02-2028
What this laboratory tests (2)
- Medical devices — 5 methods
- Cleanrooms — 4 methods
Analytical techniques used (3)
- by culture — 5 methods
- Gel method — 1 method
- Kinetic turbidimetric method — 1 method
Laboratory sections (2)
- HK Inspection Laboratory — 6 methods
- BV Inspection Laboratory — 3 methods
Laboratory locations
- Laboratorium Kontrolne HK — Kladská 1032/44c, Slezské Předměstí
- Laboratorium Kontrolne BV — Bílé Vchýnice 10
Certificate information
- Certificate date
- 13.08.2024
Accreditation scope — test methods (9)
| No. | Test object | Methodology / Parameters | Technique | Reference document | |
|---|---|---|---|---|---|
| HK Inspection Laboratory | |||||
| 1 | Medical devices | Determination of bacterial endotoxins, quantitative method Regulated area: Tests |
Kinetic turbidimetric method | SOP-K.5.01 (Ph. Eur. čl. 2.6.14, Metoda C; USP <85>; ČSN EN ISO 10993-12; ANSI/AAMI ST72) | |
| 2 | Medical devices | Determination of bacterial endotoxins, limit test Regulated area: Tests |
Gel method | SOP-K.5.02 (Ph. Eur. čl. 2.6.14, Metoda A; USP <85>; ČSN EN ISO 10993-12; ANSI/AAMI ST72) | |
| 3 | Medical devices | Determination of a population of microorganisms (bioburden) (Bile tolerant G- bacteria, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella sp.) Bile tolerant G- bacteria Staphylococcus aureus Pseudomonas aeruginosa Salmonella sp. Regulated area: Tests |
by culture | SOP-K.4.11 (ČSN EN ISO 11737-1; Ph. Eur. čl. 2.6.12, čl. 2.6.13; USP <61>; USP <62>) | |
| 4 | Cleanrooms | Determination of microbiological contamination (monitoring) aeroscope fall-outs swabs surface prints finger prints Regulated area: Tests |
by culture | SOP-K.8.01, kap. 4.1.1.1; SOP-K.8.01, kap. 4.1.2.1; SOP-K.8.01, kap. 4.2.1; SOP-K.8.01, kap. 4.3.1.1; SOP-K.8.01, kap. 4.3.2.1 | |
| 5 | Cleanrooms | Sampling of air aeroscope fall-outs Regulated area: Sampling |
SOP-K.8.01, kap. 4.1.1; SOP-K.8.01, kap. 4.1.2 | ||
| 6 | Cleanrooms | Sampling of surfaces swabs surface prints finger prints clothing prints Regulated area: Sampling |
SOP-K.8.01, kap. 4.2; SOP-K.8.01, kap. 4.3.1; SOP-K.8.01, kap. 4.3.2; SOP-K.8.01, kap. 4.3.3 | ||
| BV Inspection Laboratory | |||||
| 7 | Medical devices | Sterility test Regulated area: Tests |
by culture | SOP-K.1.01 (Ph. Eur. čl. 2.6.1; ČSN EN ISO 11737-2; USP <71>) | |
| 8 | Medical devices | Determination of a population of microorganisms (bioburden) (Bile tolerant G- bacteria, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella sp.) Bile tolerant G- bacteria Staphylococcus aureus Pseudomonas aeruginosa Salmonella sp. Regulated area: Tests |
by culture | SOP-K.4.11 (ČSN EN ISO 11737-1; Ph. Eur. čl. 2.6.12, čl. 2.6.13; USP <61>; USP <62>) | |
| 9 | Cleanrooms | Determination of microbiological contamination (monitoring) aeroscope fall-outs swabs surface prints finger prints Regulated area: Tests |
by culture | SOP-K.8.01, kap. 4.1.1.1; SOP-K.8.01, kap. 4.1.2.1; SOP-K.8.01, kap. 4.2.1; SOP-K.8.01, kap. 4.3.1.1; SOP-K.8.01, kap. 4.3.2.1 | |
Reference standards (27)
ANSI/AAMI ST72
Ph. Eur. čl. 2.6.1
Ph. Eur. čl. 2.6.12, čl. 2.6.13
Ph. Eur. čl. 2.6.14, Metoda A
Ph. Eur. čl. 2.6.14, Metoda C
SOP-K.1.01
SOP-K.4.11
SOP-K.5.01
SOP-K.5.02
SOP-K.8.01, kap. 4.1.1
SOP-K.8.01, kap. 4.1.1.1
SOP-K.8.01, kap. 4.1.2
SOP-K.8.01, kap. 4.1.2.1
SOP-K.8.01, kap. 4.2
SOP-K.8.01, kap. 4.2.1
SOP-K.8.01, kap. 4.3.1
SOP-K.8.01, kap. 4.3.1.1
SOP-K.8.01, kap. 4.3.2
SOP-K.8.01, kap. 4.3.2.1
SOP-K.8.01, kap. 4.3.3
USP <61>
USP <62>
USP <71>
USP <85>
ČSN EN ISO 10993-12
ČSN EN ISO 11737-1
ČSN EN ISO 11737-2