无菌制剂生产环境甲醛熏蒸灭菌的验证

目的:探讨无菌制剂生产环境甲醛熏蒸灭菌的验证方法。方法:对一定量甲醛气体在不同灭菌时间的环境取样进行无菌测定,且在不同时间排风后测定甲醛浓度以确定甲醛熏蒸最佳灭菌时间及排风时间。结果:最终确定了甲醛熏蒸灭菌在≥12 h时,灭菌效果最好;排风≥5h对人身健康及产品安全最佳。结论:上述甲醛熏蒸时间及排风时间仅适用于本企业粉针车间,因各制药企业空调等设备系统不尽相同,可以采用本文提示的方法进行验证后确定具体时间。

Validation method of formaldehyde suffocating sterilizationin sterile formulation production environment

Object: To investigate the validation method of formaldehyde suffocating sterilization in sterile formulation production environment.Methods: The certain amount of formaldehyde was used for sterilization.The sterile determining was conducted at different times and the concentration of formaldehyde at different exhausting times was also determined to confirm the fumigation time and the exhausting time.Results: The effective fumigation time was longer than 12 h.It was good and safe for people health and products quality when the exhaust time was longer than 5 h.Conclusion: The data in the article was only applicable to our factory.The air-condition system of each company is different,so the validation method established can also be adopted,but the time of effective fumigation and exhaustion should be further confirmed.