🇵🇱 SteriPack Medical Poland Sp. z o. o. PL
MicrobiologyEnvironmentWater & wastewater
SteriPack Medical Poland Sp. z o. o. is a laboratory accredited by PCA under number AB 1575 (Jelcz-Laskowice, Poland). Its accreditation scope covers 12 test methods in the following areas: Microbiology, Environment, Water & wastewater. Test objects include: Environmental samples E - air, Medical devices E, Biological indicators of the effectiveness of the sterilisation pro…, Environmental samples from production areas E - surface imprint.
At a glance
- Accreditation number: PCA AB 1575
- Methods in scope: 12
- Types of test objects: 6
- City: Jelcz-Laskowice, Poland
- Accreditation number
- AB 1575
- Accreditation body
- PCA
- Address
- Łęg, ul. Japońska 1, 55-220 Jelcz-Laskowice
- City
- Jelcz-Laskowice, Poland
What this laboratory tests (6)
- Environmental samples E - air — 3 methods
- Medical devices E — 3 methods
- Biological indicators of the effectiveness of the sterilisation process (Bioindicators) E — 2 methods
- Environmental samples from production areas E - surface imprint — 2 methods
- Medical devices E Water E — 1 method
- Purified water E Highly purified water E Water for injections E Water for preparation of extracts E — 1 method
Accreditation scope — test methods (12)
| No. | Test object | Methodology / Parameters | Technique | Reference document | |
|---|---|---|---|---|---|
| Test methods | |||||
| 1 | Medical devices E | Sterility Culture method | PN-EN ISO 11737-2 Ph.Eur. | ||
| 2 | Medical devices E | Microorganism count Membrane filtration method Plate method (pour plate) | PN-EN ISO 11737-1 Ph.Eur. | ||
| 3 | Medical devices E Water E | Level of bacterial endotoxins Gel-clot technique Method A: Limit test Method B: Semi-quantitative test | Ph.Eur., 2.6.14; 5.1.10 USP <85> i <161> | ||
| 4 | Environmental samples E - air | Sampling for microbiological testing Volumetric method | LAB-16.12.00 | ||
| 5 | Environmental samples E - air | Total aerobic viable count Plate method | |||
| 6 | Environmental samples E - air | Sampling for microbiological testing Gravimetric method | LAB-16.13.00 | ||
| 7 | Environmental samples from production areas E - surface imprint | Sampling for microbiological testing Contact plate method | PN-EN ISO 18593 | ||
| 8 | Environmental samples from production areas E - surface imprint | Total aerobic viable count Plate method | LAB-16.10.00 | ||
| 9 | Medical devices E | Level of bacterial endotoxins Kinetic chromogenic technique Method D: quantitative test | Ph.Eur., 2.6.14; 5.1.10 USP <85> i <161> | ||
| 10 | Purified water E Highly purified water E Water for injections E Water for preparation of extracts E | Total count of aerobic microorganisms Membrane filtration method | Ph.Eur. | ||
| 11 | Biological indicators of the effectiveness of the sterilisation process (Bioindicators) E | Presence of indicator microorganisms: Bacillus atrophaeus, Geobacillus stearothermophilus Culture method | LAB-16.09.00 | PN-EN ISO 11138-1 | PN-EN ISO 11138-7 | ||
| 12 | Biological indicators of the effectiveness of the sterilisation process (Bioindicators) E | Count of indicator microorganisms: Bacillus atrophaeus, Geobacillus stearothermophilus Plate method (pour plate) | LAB-16.09.00 w oparciu o instrukcje producentów | ||
Reference standards (12)
LAB-16.09.00
LAB-16.09.00 w oparciu o instrukcje producentów
LAB-16.10.00
LAB-16.12.00
LAB-16.13.00
PN-EN ISO 11138-1
PN-EN ISO 11138-7
PN-EN ISO 11737-1 Ph.Eur.
PN-EN ISO 11737-2 Ph.Eur.
PN-EN ISO 18593
Ph.Eur.
Ph.Eur., 2.6.14; 5.1.10 USP <85> i <161>