🇵🇱 BIO-CHIC Spółka z o. o. PL
制药与化妆品微生物环境水与废水
BIO-CHIC Spółka z o. o. 是由 PCA 认可的实验室，认可编号 AB 745（Warszawa，波兰）。认可范围涵盖 36 项检测方法，涉及以下领域：制药与化妆品、微生物、环境、水与废水。检测对象包括：Pharmaceutical preparations and non-sterile raw materials、生活饮用水、Cosmetics and cosmetic raw materials、Environmental samples in pharmaceutical and cosmetic production pla…。最常用的技术：培养法结合生化确认、膜过滤法、平板法。
要点速览
- 认可编号: PCA AB 745
- 认可范围内方法数: 36
- 检测对象种类: 10
- 所用技术数: 8
- 城市: Warszawa, 波兰
- 认可编号
- AB 745
- 认可机构
- PCA
- 地址
- LABORATORIUM MIKROBIOLOGICZNE, ul. Chłodna 56/60, 00-872 Warszawa
- 城市
- Warszawa, 波兰
该实验室检测什么 (10)
- Pharmaceutical preparations and non-sterile raw materials — 7 项方法
- 生活饮用水 — 7 项方法
- Cosmetics and cosmetic raw materials — 6 项方法
- Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – air — 5 项方法
- Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – surface contact prints — 5 项方法
- Environmental samples in pharmaceutical and cosmetic production plants and in other plants with increased hygiene standards — 2 项方法
- Pharmaceutical preparations and cosmetics — 1 项方法
- Purified water — 1 项方法
- Purified water, Water intended for human consumption, — 1 项方法
- 化妆品 — 1 项方法
所用检测技术 (8)
- 培养法结合生化确认 — 15 项方法
- 膜过滤法 — 6 项方法
- 平板法 — 4 项方法
- 平板法（倾注培养） — 4 项方法
- Plate method (pour plate) or membrane filtration method — 2 项方法
- Plate method (spread plate or pour plate) — 2 项方法
- Imprint method — 1 项方法
- Volumetric method — 1 项方法
实验室地点
- LABORATORIUM MIKROBIOLOGICZNE — ul. Chłodna 56/60
认可范围 — 项检测方法 (36)
| 序号 | 检测对象 | 方法 / 参数 | 技术 | 依据文件 | |
|---|---|---|---|---|---|
| 微生物实验室 | |||||
| 1 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with increased hygiene standards | 微生物检测用表面样品采集 | Imprint method | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 2 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – surface contact prints | 微生物总数 | 平板法 | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 3 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – surface contact prints | Fungal count | 平板法 | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 4 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – surface contact prints | 金黄色葡萄球菌（Staphylococcus aureus）检出 | 培养法结合生化确认 | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 5 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – surface contact prints | 铜绿假单胞菌（Pseudomonas aeruginosa）检出 | 培养法结合生化确认 | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 6 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – surface contact prints | Presence of Enterobacteriaceae and other gram-negative rods | 培养法结合生化确认 | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 7 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with increased hygiene standards | 微生物检测用空气样品采集 | Volumetric method | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 8 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – air | 微生物总数 | 平板法 | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 9 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – air | Fungal count | 平板法 | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 10 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – air | 金黄色葡萄球菌（Staphylococcus aureus）检出 | 培养法结合生化确认 | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 11 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – air | 铜绿假单胞菌（Pseudomonas aeruginosa）检出 | 培养法结合生化确认 | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 12 | Environmental samples in pharmaceutical and cosmetic production plants and in other plants with elevated hygiene standards – air | Presence of Enterobacteriaceae and other gram-negative rods | 培养法结合生化确认 | PB-06 wydanie 6 z dnia 20.12.2017 | |
| 13 | Pharmaceutical preparations and non-sterile raw materials | Total aerobic microbial count (TAMC) | 平板法（倾注培养） | Ph.Eur 12.1 wyd. 07.2025 Farmakopea Polska XIII wyd. 2023 Suplement 2025 do Farmakopei Polskiej XIII | PB 13 wydanie 9 z dnia 20.12.2017 | |
| 14 | Pharmaceutical preparations and non-sterile raw materials | Total combined moulds and yeasts count (TYMC) | 平板法（倾注培养） | Ph.Eur 12.1 wyd. 07.2025 Farmakopea Polska XIII wyd. 2023 Suplement 2025 do Farmakopei Polskiej XIII | PB 13 wydanie 9 z dnia 20.12.2017 | |
| 15 | Pharmaceutical preparations and non-sterile raw materials | 金黄色葡萄球菌（Staphylococcus aureus）检出 | 培养法结合生化确认 | Ph.Eur 12.1 wyd. 07.2025 Farmakopea Polska XIII wyd. 2023 Suplement 2025 do Farmakopei Polskiej XIII | PB 13 wydanie 9 z dnia 20.12.2017 | |
| 16 | Pharmaceutical preparations and non-sterile raw materials | 铜绿假单胞菌（Pseudomonas aeruginosa）检出 | 培养法结合生化确认 | Ph.Eur 12.1 wyd. 07.2025 Farmakopea Polska XIII wyd. 2023 Suplement 2025 do Farmakopei Polskiej XIII | PB 13 wydanie 9 z dnia 20.12.2017 | |
| 17 | Pharmaceutical preparations and non-sterile raw materials | Presence of bile-tolerant Gram (−) bacteria | 培养法结合生化确认 | Ph.Eur 12.1 wyd. 07.2025 Farmakopea Polska XIII wyd. 2023 Suplement 2025 do Farmakopei Polskiej XIII | PB 13 wydanie 9 z dnia 20.12.2017 | |
| 18 | Pharmaceutical preparations and non-sterile raw materials | 大肠埃希氏菌（Escherichia coli）检出 | 培养法结合生化确认 | Ph.Eur 12.1 wyd. 07.2025 Farmakopea Polska XIII wyd. 2023 Suplement 2025 do Farmakopei Polskiej XIII | PB 13 wydanie 9 z dnia 20.12.2017 | |
| 19 | Pharmaceutical preparations and non-sterile raw materials | 沙门氏菌属（Salmonella spp.）的检出 | 培养法结合生化确认 | Ph.Eur 12.1 wyd. 07.2025 Farmakopea Polska XIII wyd. 2023 Suplement 2025 do Farmakopei Polskiej XIII | PB 13 wydanie 9 z dnia 20.12.2017 | |
| 20 | Cosmetics and cosmetic raw materials | 嗜温需氧菌计数 | Plate method (pour plate) or membrane filtration method | PN-EN ISO 21149:2017-07 +A1:2023-01 z wyłączeniem punktu 9.3.2.2 i 9.4 | |
| 21 | Cosmetics and cosmetic raw materials | 酵母菌与霉菌计数 | Plate method (pour plate) or membrane filtration method | PN-EN ISO 16212:2017-08 +A1:2023-01 z wyłączeniem punktu 9.3.2.2 | |
| 22 | Cosmetics and cosmetic raw materials | 金黄色葡萄球菌（Staphylococcus aureus）检出 | 培养法结合生化确认 | PN-EN ISO 22718:2016-01 +A1:2023-01 | |
| 23 | Cosmetics and cosmetic raw materials | 铜绿假单胞菌（Pseudomonas aeruginosa）检出 | 培养法结合生化确认 | PN-EN ISO 22717:2016-01 +A1:2023-03 | |
| 24 | Cosmetics and cosmetic raw materials | 大肠埃希氏菌（Escherichia coli）检出 | 培养法结合生化确认 | PN-EN ISO 21150:2016-01 +A1:2023-03 | |
| 25 | Cosmetics and cosmetic raw materials | 白色念珠菌（Candida albicans）检出 | 培养法结合生化确认 | PN-EN ISO 18416:2016-01 +A1:2023-03 | |
| 26 | 生活饮用水 | Total count of microorganisms at 22o C | 平板法（倾注培养） | PN-EN ISO 6222:2004 | |
| 27 | 生活饮用水 | Total count of microorganisms at 36o C | 平板法（倾注培养） | PN-EN ISO 6222:2004 | |
| 28 | 生活饮用水 | 大肠菌群计数 | 膜过滤法 | PN-EN ISO 9308-1:2014-12 +A1:2017-04 | |
| 29 | 生活饮用水 | 大肠埃希氏菌（Escherichia coli）计数 | 膜过滤法 | PN-EN ISO 9308-1:2014-12 +A1:2017-04 | |
| 30 | 生活饮用水 | 粪肠球菌计数 | 膜过滤法 | PN-EN ISO 7899-2:2004 | |
| 31 | 生活饮用水 | 军团菌属细菌计数 Matryca A: Procedura 5 (pożywka A), 7 (pożywka C-GVPC) 范围 od 1cfu/100 ml |
膜过滤法 | PN-EN ISO 11731:2017-08 | PN-EN ISO 11731:2017-08/Ap1:2019-12 | |
| 32 | 生活饮用水 | 产气荚膜梭菌计数（含芽孢） | 膜过滤法 | PN-EN ISO 14189:2016 | |
| 33 | Purified water | Total aerobic microbial count (TAMC) | 膜过滤法 | Ph.Eur 12.1 wyd. 07.2025 Suplement 2024 do Farmakopei Polskiej XIII wyd. 2024 | |
| 34 | Purified water, Water intended for human consumption, | 微生物检测用样品采集 | PN-EN ISO 19458:2007 | ||
| 35 | Pharmaceutical preparations and cosmetics | Antimicrobial protection efficacy | Plate method (spread plate or pour plate) | Ph.Eur 12.1 wyd. 07.2025 Farmakopea Polska XIII wyd. 2023 | |
| 36 | 化妆品 | Antimicrobial protection efficacy | Plate method (spread plate or pour plate) | PN-EN ISO 11930:2019-03 +A1:2023-02 | |
引用标准 (19)
PB 13 wydanie 9 z dnia 20.12.2017
PB-06 wydanie 6 z dnia 20.12.2017
PN-EN ISO 11731:2017-08
PN-EN ISO 11731:2017-08/Ap1:2019-12
PN-EN ISO 11930:2019-03 +A1:2023-02
PN-EN ISO 14189:2016
PN-EN ISO 16212:2017-08 +A1:2023-01 z wyłączeniem punktu 9.3.2.2
PN-EN ISO 18416:2016-01 +A1:2023-03
PN-EN ISO 19458:2007
PN-EN ISO 21149:2017-07 +A1:2023-01 z wyłączeniem punktu 9.3.2.2 i 9.4
PN-EN ISO 21150:2016-01 +A1:2023-03
PN-EN ISO 22717:2016-01 +A1:2023-03
PN-EN ISO 22718:2016-01 +A1:2023-01
PN-EN ISO 6222:2004
PN-EN ISO 7899-2:2004
PN-EN ISO 9308-1:2014-12 +A1:2017-04
Ph.Eur 12.1 wyd. 07.2025 Farmakopea Polska XIII wyd. 2023
Ph.Eur 12.1 wyd. 07.2025 Farmakopea Polska XIII wyd. 2023 Suplement 2025 do Farmakopei Polskiej XIII
Ph.Eur 12.1 wyd. 07.2025 Suplement 2024 do Farmakopei Polskiej XIII wyd. 2024