Braun Christian, Löwel Matthias, Heuer Miriam, Pruß Axel, Schulz Tino
Institute of Legal Medicine Munich (LMU), Nussbaumstrasse 26, 80336, Munich, Germany.
DIZG Deutsches Institut für Zell- Und Gewebeersatz gGmbH, Köpernicker Str. 325, 12555, Berlin, Germany.
Cell Tissue Bank. 2025 May 26;26(3):27. doi: 10.1007/s10561-025-10174-3.
To qualify for bone donation many criteria must be met. For procurement, two time intervals-a postmortem interval (PMI) of 6 h (hours) until cooling of the deceased and a maximum procurement time of tissues within 24/36 h postmortem are mandatory. Expanding the procurement to donors with a longer PMI would be helpful e.g. to have more time to contact relatives for consent for donation. A loss of biomechanical quality of bone tissues should not be expected in the PMI until procurement, but the question of microbiological contamination remains. Therefore, samples from the iliac crest were procured under standard procurement conditions between 48 and 54 h (n = 14, group 1) and 72-78 h (n = 7, group 2) postmortem (pm). Samples were immediately frozen after procurement at < - 18 °C and sent to the German Institute for Tissue and Cell Replacement (DIZG) for mechanical preparation. Additionally, chloroform treatment was performed at the tissue bank of the Charité Berlin. After each step the samples were refrozen and sent to a contracted microbiological lab for bioburden testing according to the European Pharmacopoeia. Samples were tested after procurement, preparation, and chloroform treatment respectively. As acceptance criterion a maximum amount of 9 × 10 colony forming units per gram (CFU/g) tissue was defined. All samples were within the defined limit with a maximum value of 2.5 × 10 CFU/g. These values are in the range of bone tissues procured under non-strict-aseptic procurement conditions within 24 or 36 h and are within the capacity of the peracetic acid sterilization process used by several tissue banks.
要符合骨捐赠的条件，必须满足许多标准。对于骨采集，有两个时间间隔是强制性的——从死者死亡到尸体冷却的6小时死后间隔（PMI），以及死后24/36小时内组织的最长采集时间。将采集范围扩大到PMI更长的捐赠者会有所帮助，例如有更多时间联系亲属以获得捐赠同意。在采集前的PMI期间，预计骨组织的生物力学质量不会丧失，但微生物污染问题仍然存在。因此，在死后48至54小时（n = 14，第1组）和72 - 78小时（n = 7，第2组）按照标准采集条件采集髂嵴样本。采集后样本立即在<-18°C下冷冻，并送往德国组织和细胞替代研究所（DIZG）进行机械制备。此外，在柏林夏里特医院的组织库进行氯仿处理。每一步之后，样本重新冷冻并送往一家签约的微生物实验室，根据欧洲药典进行生物负荷测试。分别在采集、制备和氯仿处理后对样本进行测试。定义的接受标准是每克组织最多9×10菌落形成单位（CFU/g）。所有样本均在规定限值内，最大值为2.5×10 CFU/g。这些值处于在24或36小时内非严格无菌采集条件下采集的骨组织范围内，并且在几个组织库使用的过氧乙酸灭菌工艺能力范围内。
