洁净区物品传递(特别是向A/B级传递物品),除欧盟GMP附录1第4章有部分描述外,其他还有哪个法规或指南有详细描述(不包括中国GMP指南无菌附录)?
QA生产管理其他无菌制剂分册

洁净区物品传递(特别是向A/B级传递物品),除欧盟GMP附录1第4章有部分描述外,其他还有哪个法规或技术指南有详细描述(不包括中国GMP指南无菌分册)?

2023-02-09 11:47 Sumei     
1个回答

     关于洁净区物品传递其它相关指南可参考以下:

1.  PDA TR.70---无菌生产设施的清洁消毒程序原理:关于厂房设施无菌工艺区域(APA)内物品的引入内容

     Items entering the APA should be exposed to the highest level of decontamination that the material can withstand. If an item can be physically sterilized, it must be. The two most widely used methods of sterilizing items entering the APA are autoclaving and gamma irradiation. For items that are gamma irradiated, a number of wraps, barriers, or layers that can be removed when passing to a more stringent grade are normally used. This concept of usingmultiple outer layers can also be applied to items that are autoclaved, if the autoclave does not directly open into the APA. Items that cannot withstand the temperatures of autoclaving or rigors of irradiation should be introduced using a decontamination process (VPHP, for example) within a pass-through or a manual disinfection (i.e., spraying or wiping) using a sporicidal agent. Ultraviolet (UV) pass-through systems can also be used to reducebioburden of items but should not be considered a sterilization method.

2. Guidance for Industry: Sterile Drug Products Producedby Aseptic Processing—Current Good ManufacturingPractices; U.S. Food and Drug Administration,2004:FDA无菌药品生产行业指南--提到物品/消耗品传递

    .......Multiple material transfers are generally made during the processing of a batch. Frequently,transfers are performed via direct interface with manufacturing equipment. Properly maintainedand operated rapid transfer ports (RTPs) are an effective transfer mechanism for aseptic transferof materials into and out of isolators.......

3. ISPE baseline vol 3 Sterile Product Manufacturing Facilities 2011

   4.6 Transfer Zones等章节均有描述。

2023-02-09 18:54 空空如也