NorthStar Nuclear Medicine, LLC, Greensboro, NC 17429, USA.
Am J Health Syst Pharm. 2010 Feb 15;67(4):280-6. doi: 10.2146/ajhp090290.
An endotoxin testing program for high-risk-level compounded sterile preparations (CSPs) was verified for compliance with finished-preparation release test requirements of United States Pharmacopeia chapter 797 and implemented at an institutional compounding pharmacy.
An efficient bacterial endotoxins test (BET) was sought for finished-preparation testing of high-risk-level CSPs prepared in batches of > or =25 units. An automated photometric BET was selected that utilized dried, pre-calibrated Limulus amebocyte lysate cartridges rather than liquid reagents and standards. Endotoxin testing began after verifying test conditions for each CSP and approving a standard procedure for training BET analysts and maintaining uniform methodology. A pharmacopeial endotoxin limit and limit dilution were determined for each CSP. The majority of CSPs included patient-controlled analgesia solutions, epidural analgesia solutions, and cardioplegia solutions. BET conditions were verified by measuring the recovery of endotoxin positive controls in sterile water dilutions for each CSP. Cardioplegia solutions met an endotoxin limit of 0.5 EU/mL, and epidural bags had an intrathecal endotoxin limit of 0.05 EU/mL. All other CSPs had detection limits well within compendial requirements. All test results collected during the first year of implementation were pyrogen free, which provided compelling evidence of appropriate application of aseptic technique, appropriate selection of equipment and methods, and the nonpyrogenic quality of powders used in compounding at the pharmacy.
A photometric endotoxins test that met all requirements of the BET was verified and implemented for high-risk-level CSPs prepared in an institutional pharmacy.
为了符合美国药典第 797 章对成品制剂放行测试的要求，我们对高风险级别复方无菌制剂（CSP）的内毒素测试程序进行了验证，并在机构制剂药房实施。
我们寻求一种高效的细菌内毒素测试（BET）方法，用于测试批量>或=25 单位的高风险级别 CSP 的成品制剂。我们选择了一种自动化比色 BET 方法，该方法使用干燥、预校准的鲎试剂试剂盒，而不是液体试剂和标准品。在验证了每种 CSP 的测试条件并批准了培训 BET 分析员和保持统一方法的标准程序后，开始进行内毒素测试。我们为每种 CSP 确定了药典内毒素限度和限度稀释度。大多数 CSP 包括患者自控镇痛溶液、硬膜外镇痛溶液和心脏停搏液。通过测量每种 CSP 的无菌水稀释液中阳性对照内毒素的回收率，验证了 BET 条件。心脏停搏液符合 0.5EU/mL 的内毒素限度，硬膜外袋的鞘内内毒素限度为 0.05EU/mL。所有其他 CSP 的检测限均远低于药典要求。在实施的第一年中收集的所有测试结果均无热原，这为适当应用无菌技术、适当选择设备和方法以及药房制剂中使用的粉末无热原质量提供了有力证据。
我们验证并实施了一种符合 BET 所有要求的比色内毒素测试方法，用于制备机构药房的高风险级别 CSP。
