Introduction: The European Pharmacopoeia (Ph. Eur.) provides principles for microbiological testing of tissue preparations. According to the Ph. Eur., tests should be performed at different temperatures for detection of aerobic bacteria and fungi (20–25°C) vs. anaerobic bacteria (30–35°C). Semiautomated systems using blood culture bottles are already widely used and they are adequate for growth detection. Resin-containing bottles and the addition of penicillinase permit testing of culture media containing antibiotics. Materials and Methods: At 3 temperatures (21, 30, and 35°C) cornea culture media with and without dextran (CM II and CM I) and thermal disinfected femoral head medium (FH) were spiked with the 6 reference strains recommended by the Ph. Eur. (additionally: Enterococcus faecalis, Staphylococcus epidermidis, and Cutibacterium acnes). Microbial growth was monitored with the BACTEC^TM FX unit or visually at 21°C. Results: Growth for all strains was detected with each medium at all 3 temperatures, except for C. acnes at 21°C (all media) and 30°C with FH. C. acnes had the highest times to detection, requiring test durations of 14 days. Microbial growth was faster at 30 and 35°C compared to 21°C. Conclusion: The requirements according to the Ph. Eur. for a successful method suitability test could be fulfilled for the semiautomated blood culture bottle system with the BACTEC^TM FX unit for the media and microorganisms used. In the presented validation study 35°C was shown to be the incubation temperature with the fastest growth, of the majority of the test strains used, and complete detection within 14 days.
Transfus Med Hemother

中文翻译：

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不同培养温度下组织制剂微生物学检测的验证

简介：欧洲药典 (Ph. Eur.) 提供了组织制剂微生物学检测的原则。根据 Ph. Eur.，应在不同温度下进行测试，以检测需氧细菌和真菌（20-25°C）与厌氧细菌（30-35°C）。使用血培养瓶的半自动化系统已经被广泛使用，它们足以用于生长检测。含有树脂的瓶子和添加青霉素酶允许测试含有抗生素的培养基。材料和方法：在 3 种温度（21、30 和 35°C）下，在含有和不含葡聚糖（CM II 和 CM I）和热消毒股骨头培养基 (FH) 的角膜培养基中加入 6 种参考菌株。欧元博士。（此外：粪肠球菌、表皮葡萄球菌和痤疮角质杆菌）。^{使用 BACTEC TM} FX 装置或在 21°C 下目测监测微生物生长。结果：除了21°C（所有培养基）和 30°C FH的痤疮丙酸杆菌外，在所有 3 个温度下，每种培养基都检测到所有菌株的生长。痤疮丙酸杆菌的检测时间最长，需要 14 天的测试时间。与 21°C 相比，30°C 和 35°C 的微生物生长速度更快。结论：根据Ph. Eur的要求。^{使用 BACTEC TM}的半自动血培养瓶系统可以成功地完成方法适用性测试用于所用培养基和微生物的 FX 单元。在提出的验证研究中，35°C 被证明是大多数使用的测试菌株中生长最快的孵化温度，并且在 14 天内完成检测。
Transfus Med Hemother