🇵🇱 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 14 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. Most frequently used techniques: Plate method, Microscopic method, Contact plate method.
At a glance
- Accreditation number: PCA AB 1575
- Methods in scope: 14
- Types of test objects: 7
- Techniques used: 11
- 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 (7)
- Environmental samples E - air — 4 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
- Infusion equipment for medical use — 1 method
- Medical devices, water — 1 method
- Purified water E, Highly purified water E, Water for injections E, Water for preparing extracts E — 1 method
Analytical techniques used (11)
- Plate method — 3 methods
- Microscopic method — 2 methods
- Contact plate method — 1 method
- Culture method — 1 method
- Direct plating culture method — 1 method
- Gravimetric method — 1 method
- Kinetic chromogenic technique; Method D: quantitative test — 1 method
- Membrane filtration method — 1 method
- Membrane filtration method; Plate method (pour plate) — 1 method
- Plate method (pour plate) — 1 method
- Volumetric method — 1 method
Laboratory locations
- SteriPack Medical Poland Sp. z o. o. (main site) — ul. Japońska 1, 55-220 Jelcz-Laskowice
- SMP Laboratory — Łęg, ul. Japońska 1, 55-220 Jelcz-Laskowice
- SMP Laboratory; Łęg, ul. Japońska 1, 55-220 Jelcz-Laskowice
Certificate information
- Issue date
- 31.08.2026
- Issue no.
- 15
Accreditation scope — test methods (14)
| No. | Test object | Methodology / Parameters | Technique | Reference document | |
|---|---|---|---|---|---|
| SMP Laboratory; Łęg, ul. Japońska 1, 55-220 Jelcz-Laskowice | |||||
| 1 | Medical devices E | Sterility Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
Direct plating culture method | PN-EN ISO 11737-2 | Ph.Eur., 2.6.1 1) | |
| 2 | Medical devices E | Microorganism count Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
Membrane filtration method; Plate method (pour plate) | PN-EN ISO 11737-1 | Ph.Eur., 2.6.12 | |
| 3 | Environmental samples E - air | Sampling for microbiological testing Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
Volumetric method | LAB-16.12.00 | |
| 4 | Environmental samples E - air | Total aerobic viable count Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
Plate method | LAB-16.12.00 | |
| 5 | Environmental samples E - air | Sampling for microbiological testing Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
Gravimetric method | LAB-16.13.00 | |
| 6 | Environmental samples E - air | Total aerobic viable count Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
Plate method | LAB-16.13.00 | |
| 7 | Environmental samples from production areas E - surface imprint | Sampling for microbiological testing Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
Contact plate method | PN-EN ISO 18593 | |
| 8 | Environmental samples from production areas E - surface imprint | Total aerobic viable count Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
Plate method | LAB-16.10.00 | |
| 9 | Medical devices E | Level of bacterial endotoxins Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
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 preparing extracts E | Total aerobic viable count Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
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 Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
Culture method | LAB-16.09.00 w oparciu o PN-EN ISO 11138-1, PN-EN ISO 11138-7 | |
| 12 | Biological indicators of the effectiveness of the sterilisation process (Bioindicators) E | Number of indicator microorganisms: Bacillus atrophaeus, Geobacillus stearothermophilus Regulated area: E – Flexible scope of accreditation. Flexible scope includes the elements indicated in document DA-10 for the scope of accreditation of testing laboratories. A list of activities conducted under the flexible scope of accreditation shall be made available on request by the accredited body. |
Plate method (pour plate) | LAB-16.09.00 w oparciu o instrukcje producentów | |
| 13 | Medical devices, water | Number and size of subvisible particles ≥10 μm ≥25 μm |
Microscopic method | Ph. Eur.12, 2026, 2.9.19 | USP-NF; <788> current as of 21.11.2025 | |
| 14 | Infusion equipment for medical use | Number and size of subvisible particles, 25 - 50 μm 51 - 100 μm >100 μm |
Microscopic method | PN-EN ISO 8536-4:2020 | |
Reference standards (16)
LAB-16.09.00 w oparciu o PN-EN ISO 11138-1, PN-EN ISO 11138-7
LAB-16.09.00 w oparciu o instrukcje producentów
LAB-16.10.00
LAB-16.12.00
LAB-16.13.00
PN-EN ISO 11737-1
PN-EN ISO 11737-2
PN-EN ISO 18593
PN-EN ISO 8536-4:2020
Ph. Eur.12, 2026, 2.9.19
Ph.Eur.
Ph.Eur., 2.6.1 1)
Ph.Eur., 2.6.12
Ph.Eur., 2.6.14; 5.1.10
USP <85> i <161>
USP-NF; <788> current as of 21.11.2025