运营商压力因素和细胞处理设施中的细胞污染风险:基于在线调查的分析分析
Yoshimi Sugahara1, Mitsuru Mizuno2, Noe Miyashita1
1Solution Development Department, Pharmaceutical & Biopharmaceuticals Engineering Division, Hitachi Plant Services Co., Ltd., 1-1, Higashi-ikebukuro 3-chome, Toshima-ku, Tokyo 170-6034, Japan.
Regenerative therapy
|April 25, 2025
概括
细胞加工经营者由于再生医学设施的污染风险而面临重大心理负担. 通过更好的实践来解决这些风险,可以提高操作员的福祉和细胞治疗产品的质量.
科学领域:
- 再生医学是一种再生医学.
- 细胞疗法制造业 细胞疗法制造业
- 职业心理学 职业心理学
背景情况:
- 再生医学正在进步,导致更多已批准的细胞疗法.
- 细胞处理设施 (CPF) 在很大程度上依赖于细胞处理运营商 (CPO) 的手动操作.
- 严格的无菌要求和复杂的细胞培养会给CPO带来心理压力,尤其是在污染方面.
研究的目的:
- 调查污染风险对细胞培养中的CPO的心理影响.
- 确定有关CPF污染的担忧和目前的缓解策略.
- 检查操作实践,如物料处理和生物安全柜 (BSC) 的使用.
主要方法:
- 在47个地点向CPO发放了一份在线调查.
- 该调查评估了污染问题,个人污染经验,并实施了风险减轻策略.
- 还检查了运营实践,包括物料处理和BSC利用.
主要成果:
- 72%的CPO表示担心污染,而18%的人直接经历过污染.
- 感知到的污染风险似乎高于报告的事件.
- 在设施之间观察到BSC利用和物料处理实践的显著差异.
结论:
- 实施特定地点的风险评估和基于证据的数据可以减轻污染风险.
- 解决这些运营挑战可以减少CPO的心理压力.
- 改善设施实践可以提高细胞疗法产品质量和CPO福祉.
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