PDA新文件中对于无菌手套监控的问答

稚子

Topic A: Glove Monitoring
Topic A: 手套监控
Problem Statement 问题描述
When and under what conditions should gloves be monitored or changed?
何时并且在什么条件下应该对手套进行监测或者更换？
Recommendation 建议
The monitoring and changing of sterile gloves should be based upon the evaluation of the risk to products, product components, and product contact surfaces and based upon the specific process.
对无菌手套的监控和更换应该基于对产品、产品组分和产品接触表面的风险，并基于特殊的工艺特点。
NOTE: Isolator/RABS gloves are not within the scope of this topic. 注意：隔离器/RABS手套不在此话题范围内。
Monitoring (microbiological sampling): 监控（微生物取样）：
• After an intervention where inappropriate contact with product contact surfaces may have occurred, such as a failure to adhere to first-air requirements or contact with gloves instead of an approved tool or device 在不适当的接触产品表面造成干扰的时候，例如没有满足first-air要求或者戴手套接触而不是用批准的工具或设备。
• Periodically, as defined by internal procedures 定期监控，如公司内部程序规定的
• Monitoring of gloves should not occur immediately after sanitization
• Upon exiting from the sterile area 从无菌区域退出的时候
• As deemed necessary based upon a specific process risk 基于特定的工艺风险而被认为是必要的情况
Change: 更换
• Sterile gloves should be changed when there are indications of tears/rips/ or gaps. 当有裂缝、缺口的时候无菌手套应该更换。
• Note that torn and ripped gloves during cleanroom operations should be recorded in the batch record. 应注意在洁净室操作过程中撕裂的手套应该记录在批记录中。
• After an intervention or contact that may compromise the cleanliness of a glove and sanitization might not return the glove to the proper conditions 在干涉或者接触手套后，可能对手套的清洁造成危害，而且清洁处理无法使手套恢复到合适的状态。
• After all finger-impression plating 在手指进行压过表面皿后
• As deemed necessary based upon a specific process risk基于特定的工艺风险而被认为是必要的情况
Rationale for Recommendation 推荐的理由
The primary source of microbial contamination of aseptic processing areas is personnel. Sterile gloves are used to prevent transfer of contamination. 无菌区域微生物污染的主要来源是人员。无菌手套是用于阻止污染的转移。
Glove changing and sanitization are key components of the contamination-control program. The purpose of monitoring is to assess the condition of the gloves after use.
Sanitization of gloves directly before monitoring may compromise the validity of this test by killing microorganisms which may be present. Therefore, procedures should specify acceptable timing to allow a meaningful evaluation of glove contamination. Both contact and evaporation are important in sanitization with alcohol. 更换手套和消毒是进行污染控制的关键内容。监控的目的是为了评价使用后的手套的状态。监控前进行手套消毒可能杀灭可能存在的微生物从而降低了此项测试的有效性。因此，程序要明确可接受的时机以便于对手套污染实现有意义额评估。在用酒精消毒的时候，接触和蒸发都很重要。

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