附录1无菌药品扎盖条款的理解

残伤

无菌附录：（2）根据已压塞产品的密封性、轧盖设备的设计、铝盖的特性等因素，轧盖操作可选择在C级或D级背景下的A级送风环境中进行。A级送风环境应当至少符合A级区的静态要求。
轧盖背景级别的设置要从已压塞产品的密封性、轧盖设备的设计、铝盖的特性等因素出发，分别指的哪些方面？

2643649441

轧盖设备得有除铝屑的装置

1009889281

请参考PIC/S对欧盟GMP附件一的解释。
Section 120:
New text: Vial capping can be undertaken as an aseptic process using sterilized caps or as a clean process outside the aseptic core. Where this latter approach is adopted, vials should be protected by grade A conditions up to the point of leaving the aseptic processing area, and thereafter stoppered vials should be protected with a grade A air supply until the cap has been crimped.
Interpretation: For lyophilized products: product transfer from filling machine to freeze dryer should be done under grade A conditions (e.g. laminar air flow mobile unit) with grade B surroundings. Transfer to the crimp-capping machine should be done under grade A air supply. For liquid products and powders: transfer from the aseptic processing area to the crimp capping machine should be done under grade A air supply. For all products: Crimp capping should be done under grade A air supply. Sterilization of crimp caps is only mandatory, when crimp capping is performed in the aseptic core.
The new revision of Annex 1 mentions a new term, Grade A air supply, but no definition of this new term is given in the revised Annex. Inspectors and Industry therefore need an interpretation of this term, especially as a provision of a grade A air supply is one of the most significant changes in Annex 1.
The term grade A air supply is specifically used to describe a supply of air which is HEPA filtered, and at the point of supply meets when tested, the non-viable particulate requirements of a grade A area, as defined in paragraph 4 of the revised Annex 1. It is important to differentiate between the terms grade A air supply and grade A area. A grade A air supply should be qualified and monitored as follows:
Qualification requirements:
• Qualification is done only under at rest conditions: For the crimp-capping machine the at-rest state is achieved when the air supply is switched on, the crimp-capping machine is operating (feeding of vials and crimp caps is not considered necessary) and there is no interference by operators. For the conveyor tunnel for liquid products the at-rest state is achieved when the air supply is switched on, the conveyor belt is switched on and there is no interference by operators.
• Non-viable particles should be measured and are expected to meet grade A requirements. The probe should be located at the point of supply of the filtered air.
• Smoke studies should be performed. Whilst unidirectional air flow is not required, efficient protection of the vials should be demonstrated and the
absence of air entrainment from the surrounding room should be demonstrated.
• Limits for air velocity should be in place and justified.
Monitoring requirements:
• Monitoring requirements for non-viable particles and microbiological contamination should be defined by the company following a risk assessment.

残伤

1009889281 发表于 2013-5-25 15:19
请参考PIC/S对欧盟GMP附件一的解释。
Section 120:
New text: Vial capping can be undertaken as an ase ...

谢谢  不过英语水平有点低

1009889281

残伤 发表于 2013-5-25 15:21
谢谢  不过英语水平有点低

您是冻干产品，轧盖是D级背景A级就可以。
A级供风指静态条件下A级，要监测粒子数、气流流型。
悬浮粒子数和微生物监测要以风险评估为基础。

yuansoul

1009889281 发表于 2013-5-25 15:19
请参考PIC/S对欧盟GMP附件一的解释。
Section 120:
New text: Vial capping can be undertaken as an ase ...

好像和他问的。。。。差异比较大

四叶花

A/B省事，虽然运营成本稍高些，安全！

1009889281

Chinagmp 老徐的翻译。
http://www.chinagmp.net/forum.php?mod=viewthread&action=printable&tid=31239

残伤

yuansoul 发表于 2013-5-25 15:37
好像和他问的。。。。差异比较大

请楼主解释一下噻   谢谢

残伤

四叶花 发表于 2013-5-25 15:37
A/B省事，虽然运营成本稍高些，安全！

我们设计就是B+A, 今天又看条款有次一问

1009889281

yuansoul 发表于 2013-5-25 15:37
好像和他问的。。。。差异比较大

感谢提醒。
轧盖背景级别的设置要从已压塞产品的密封性、轧盖设备的设计、铝盖的特性等因素出发，分别指的哪些方面？
其实如果再轧盖前不能将缺塞或没有盖好塞子的瓶子剔除掉，不管是C或D都是风险很大的。我们是自动剔除，所以轧盖操作不会有认为干扰。

轧盖设备的设计、铝盖的特性等因素出发 还请继续讨论。

yuansoul

1009889281 发表于 2013-5-25 15:46
感谢提醒。
轧盖背景级别的设置要从已压塞产品的密封性、轧盖设备的设计、铝盖的特性等因素出发，分别指 ...

目前欧盟推荐C+A

yuansoul

残伤 发表于 2013-5-25 15:41
请楼主解释一下噻   谢谢

你提问我一定要认真喷水的，谦虚谨慎、不骄不躁、温度适中、相对湿度符合一贯作风、长期稳定性极好：

“轧盖背景级别的设置要从已压塞产品的密封性“，很多胶塞可以免洗、有的也不需要硅化，但是有的需要自己洗，然后硅化，所以这个摩擦力差异很大。容易跳塞、或者胶塞不平。。。也有的胶塞本身有脱落物，也有的本身靠清洗也洗不掉的纤维、毛团、毛点。所以如果气流结构不好、或则洁净级别不适合、或者气流速度不够，都可能造成可见异物、不溶微粒超标、或者超趋势。
”轧盖设备的设计“目前国内铝盖产品质量不稳定，脱落物很多，并且灌装机、压盖机，很多企业没有实际的”接地“而造成运转过程中静电效应，铝盖脱落物被吸附、吹散。。。。
”铝盖的特性“铝盖特性参考上一条

liuqygood2005

多谢分享。

残伤

yuansoul 发表于 2013-5-25 18:10
你提问我一定要认真喷水的，谦虚谨慎、不骄不躁、温度适中、相对湿度符合一贯作风、长期稳定性极好：

...

谢谢楼主了

残伤

liuqygood2005 发表于 2013-5-25 18:18
多谢分享。

分享啥呢

yuansoul

残伤 发表于 2013-5-26 07:24
谢谢楼主了

貌似你是楼主啊

残伤

yuansoul 发表于 2013-5-26 07:38
貌似你是楼主啊

哈哈  不好意思

残伤

zmjxlp932 发表于 2013-5-26 08:09
C+A

轧盖背景级别的设置要从已压塞产品的密封性、轧盖设备的设计、铝盖的特性等因素出发，分别指的哪些方面？

追风者

yuansoul 发表于 2013-5-25 18:10
你提问我一定要认真喷水的，谦虚谨慎、不骄不躁、温度适中、相对湿度符合一贯作风、长期稳定性极好：

...

同意看法！