对非无菌药物制造产品接触表面的微生物控制:海报在2025年PDA周发布
1STERIS Corporation, Dublin, Ireland antonio_ortiz@steris.com.
PDA journal of pharmaceutical science and technology
|August 1, 2025
概括
对于非无菌药物制造,清洗后可能不需要单独的消毒步骤. 通过风险评估和数据支持的有效清洁过程,可以控制设备表面的微生物污染.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 控制和控制微生物污染
- 过程验证 过程验证
背景情况:
- 消毒处理清洁侧重于灭菌前的交叉污染和生物负担减轻.
- 对于非无菌产品接触面的生物负担限值存在有限的指导.
- 这种差距引发了对非无菌制造设备清洗后消毒的必要性的问题.
研究的目的:
- 评估非无菌药物制造设备清洗后是否需要单独的消毒或消毒步骤.
- 探索风险评估和过程控制在管理微生物污染中的作用.
- 为了确定有效的清洁过程是否可以消除对额外消毒步骤的需求.
主要方法:
- 审查监管指导,特别是USP <1115>,关于微生物限制和基于风险的方法.
- 分析影响有效清洁过程设计的因素.
- 评估证明清洁工艺在控制微生物污染方面的有效性数据.
主要成果:
- USP<1115>建议基于风险评估和产品特定控制的微生物限制和清洁过程设计.
- 解决产品残留和微生物污染的综合清洁过程是有益的.
- 在清洁过程中进行适当的控制可能会消除对单独消毒步骤的需求.
结论:
- 对于非无菌药物制造设备,如果清洁过程是稳健的和经过验证的,可能不需要单独的消毒或消毒步骤.
- 通过清洁来有效控制微生物污染的数据至关重要.
- 基于风险的方法和全面的工艺设计是确保产品安全和质量的关键.
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