验证自动发放系统用于随后的不同放射性核素剂量发放
T T Cao1,2, E A Aalbersberg1, M M Geluk-Jonker1,3
1Department of Nuclear Medicine, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
EJNMMI radiopharmacy and chemistry
|February 12, 2024
概括
放射性药物的自动化分发系统 (ADS) 确保准确的剂量和减少辐射暴露. PT459R2 ADS符合GMP和GRPP指导方针,用于放射性药房的安全和有效使用.
科学领域:
- 核医学是一种核医学.
- 放射药房运营 放射药房运营
- 质量保证 质量保证 质量保证
背景情况:
- 放射性药物的自动化分发系统 (ADS) 对于最大限度地减少人员的辐射暴露,提高剂量准确性和防止微生物污染至关重要.
- 在实施之前,系统验证至关重要,以确保安全和质量,遵守良好的制造实践 (GMP) 和良好的辐射保护实践 (GRPP) 准则.
研究的目的:
- 介绍Lynax s.r.o.的PT459R2自动化剂量系统 (ADS) 的选择,验证和实施的指导协议.
- 根据GMP和GRPP指南验证ADS,重点关注内部探测器的准确性,精度和无菌分发能力.
主要方法:
- 验证包括评估内部闪探测器在各种同位素 (-177,-89,-68,-18) 的线性,准确性和精度.
- 进行了微生物学验证,以确保无菌分发程序.
- 进行了性能合格 (PQ) 评估,以评估系统是否适合常规使用.
主要成果:
- 在多个同位素的特定范围内,ADS证明了准确的剂量分配,最大偏差为2.35%和变化系数为3.03%,符合<5%的接受标准.
- 该系统在层状空气流柜内保持了GMP A 级环境,并进行了无菌分剂.
- 证实了可接受的辐射暴露水平和保存的数据完整性.
结论:
- PT459R2 ADS成功满足了所有性能合格要求,证实了其适用于日常放射性药房操作的适用性.
- 提出的验证方法作为一个有价值的指导协议,用于ADS在放射药房的性能资格,与GMP和GRPP标准保持一致.
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