医疗器械产品消毒剂要轮换使用防止耐药性 Disinfectants for medical device products

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《医疗器械生产质量管理规范》及其附录（中国GMP）

• 文件名称：原国家食品药品监督管理总局公告2014年第64号《医疗器械生产质量管理规范》及无菌、植入性医疗器械等附录。
• 相关条款：
  • 要求企业建立洁净室（区）环境监测程序，包括微生物监控。
  • 要求对消毒效果进行验证和定期再验证。
  • 虽未明说“轮换”，但要求验证消毒方法的持续有效性。如果长期使用单一消毒剂导致微生物产生适应性（耐受性），则原有验证失效，企业必须采取措施（如轮换）来保证消毒效果。
    
• 逻辑关联：为满足“持续有效消毒”的要求，轮换使用不同作用机制的消毒剂被视为一种有效的风险控制手段。
  

Good Manufacturing Practice for Medical Devices and its Appendix (China GMP)
Document Name: Announcement No. 64 of 2014 by the former State Food and Drug Administration, "Quality Management Standards for Medical Device Production" and its appendices on sterile and implantable medical devices.
Related terms:
Require enterprises to establish environmental monitoring procedures for clean rooms (areas), including microbiological monitoring.
Require validation and regular re validation of disinfection effectiveness.
Although it is not explicitly stated as' rotation ', it is required to verify the sustained effectiveness of the disinfection method. If the long-term use of a single disinfectant leads to microbial adaptation (tolerance), the original validation will be invalidated, and the enterprise must take measures (such as rotation) to ensure disinfection effectiveness.
Logical correlation: To meet the requirement of "continuous and effective disinfection", rotating the use of disinfectants with different mechanisms of action is considered an effective risk control measure.

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《中国药典》2020年版 四部

• 相关章节：通则《9205 消毒剂效力验证指导原则》（原《9207 洁净区环境监测》中相关内容已整合）。
• 关键内容：
  • 明确要求对消毒剂的效力进行验证，测试其对细菌、真菌、芽孢的杀灭能力。
  • 要求验证应能代表实际使用条件。
  • 虽然未强制要求轮换，但该指导原则的目的是确保消毒剂在实际使用中持续有效。长期使用单一消毒剂可能导致环境中出现耐受菌株，从而使验证结果失真或失效。
    
• 行业实践：为确保消毒剂效力验证的长期有效性，GMP检查员和企业普遍采纳轮换策略。
  

Chinese Pharmacopoeia 2020 Edition Volume Four
Related Chapters: General Principles for Validation of Disinfectant Efficacy in 9205 (Relevant content from the original 9207 Clean Area Environmental Monitoring has been integrated).
Key content:
It is explicitly required to verify the effectiveness of disinfectants and test their ability to kill bacteria, fungi, and spores.
Verification should be able to represent actual usage conditions.
Although rotation is not mandatory, the purpose of this guideline is to ensure that disinfectants remain effective in practical use. Long term use of a single disinfectant may lead to the emergence of tolerant strains in the environment, resulting in distorted or ineffective validation results.
Industry practice: To ensure the long-term effectiveness of disinfectant efficacy verification, GMP inspectors and enterprises generally adopt a rotation strategy.

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ISO 14644 系列标准（洁净室及相关受控环境）

• 国际标准，被中国广泛参考和采用。
• ISO 14644-3:2019 中提到，应定期评估和审查洁净室的清洁和消毒程序，以确保其有效性。
• 轮换消毒剂被视为一种降低微生物适应风险的推荐做法。
  

ISO 14644 series standards (cleanrooms and related controlled environments)
International standards are widely referenced and adopted by China.
ISO 14644-3:2019 states that the cleaning and disinfection procedures of cleanrooms should be regularly evaluated and reviewed to ensure their effectiveness.
Rotating disinfectants are considered a recommended practice to reduce the risk of microbial adaptation.

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为什么需要轮换消毒剂？

原因

说明

防止微生物适应/耐受性

长期暴露于同一种消毒剂，可能导致环境中出现对该消毒剂耐受的微生物菌株，降低消毒效果。

广谱覆盖

不同消毒剂对不同微生物（细菌、真菌、芽孢、病毒）的杀灭效果不同。轮换使用可确保更全面的微生物控制。

避免生物膜形成

某些消毒剂（如季铵盐类）长期使用可能促进生物膜形成。轮换可打破此风险。

满足验证要求

确保消毒剂效力验证（Disinfectant Efficacy Testing）结果的长期有效性。

Why is it necessary to rotate disinfectants?
Reason explanation
Preventing long-term exposure of microorganisms to the same disinfectant may lead to the emergence of microbial strains that are tolerant to the disinfectant in the environment, thereby reducing the effectiveness of disinfection.
The broad-spectrum coverage of different disinfectants has different killing effects on different microorganisms (bacteria, fungi, spores, viruses). Rotating use can ensure more comprehensive microbial control.
Avoid biofilm formation. Long term use of certain disinfectants (such as quaternary ammonium salts) may promote biofilm formation. Rotation can break this risk.
Meet the validation requirements to ensure the long-term effectiveness of disinfectant efficacy testing results.

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