A级层流和A级送风的区别是什么

一般坏而已

如题：A级层流和送风的区别是什么  ，要说到点上哦

andysky

有两种情况：1、A级层流按A级送风，A级管理；2、A级层流按A级送风，B/C/D级管理，根据工艺级风险评估来定。

一般坏而已

andysky 发表于 2019-3-25 12:10
有两种情况：1、A级层流按A级送风，A级管理；2、A级层流按A级送风，B/C/D级管理，根据工艺级风险评估来定。 ...

不是，我是说A级层流和A级送风本质区别在哪里，你这个理解也是对的 我想知道怎么来区分的，点在哪里

一般坏而已

一般坏而已 发表于 2019-3-25 12:14
不是，我是说A级层流和A级送风本质区别在哪里，你这个理解也是对的 我想知道怎么来区分的，点在哪里

还有一个是层流，一个是送分，你说的都是层流呀

zj3801033

A级层流：指的是A级洁净级别的单向流，A级送风：是指有区域需要A级洁净风保护，最常见的BFS的灌装区，A级风保护。

jiangbj

PI 032_2 GMP Annex 1 Revision 2008, Interpretation Of Most Important Changes for the Manufacture Of Sterile Medicinal Products

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-cappingmachine 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.

ning_zilv

jiangbj 发表于 2019-03-25 12:28
PI 032_2 GMP Annex 1 Revision 2008, Interpretation Of Most Important Changes for the Manufacture Of Sterile Medicinal Products

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-cappingmachine 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.

什么文件，文件名称发一下，学习学习该文件

来自安卓APP客户端

liliang810804

A级层流是指A级环境单向流，静态、动态都应符合A级标准；
A级送风是指松A级洁净风保护局部环境，不是单向流，静态符合A级动态不一定符合。比如“老鼠洞口”

ptq518

一个A级层流要求动态符合A级,A级送风静态符合A级即可

jiangbj

ning_zilv 发表于 2019-3-25 12:43
什么文件，文件名称发一下，学习学习该文件

PICS 指南 ，自己到PICS网站上去下载吧

PI 032_2 GMP Annex 1 Revision 2008, Interpretation Of Most Important Changes for the Manufacture Of Sterile Medicinal Products

ning_zilv

谢谢，我去查一下文件

旮旯小风

（转自公众号“全球药事”）A级送风（Grade A air supply）和A级（Grade A）是两个不同的概念，通常一旦提到A级，就会有B级作为背景，比如灌装、分装、压塞、过滤药液（无法除菌）的配制、已灭菌物品（未完全密封）的转移，无菌原料药的粉碎、过筛、混合等，而例外情况是Isolator内部属于A级，但它的周围可以是C级甚至D级；但提到A级送风，通常它的背景是C级或D级，比如轧盖区域、待灭菌物品的整理、称量的层流等等。

早期，一些企业没有将两个概念区分开，对A级送风和A级进行同样的管理。后来，在药品生产质量管理规范（2010年修订）的附录1 《无菌药品》中第十三条提到了“A级送风”的概念，要求A级送风的环境应当至少符合A级区的静态要求。对于动态并没有要求。

其实，PIC/S（Pharmaceutical Inspection Co-operation Scheme）国际药品认证合作组织在《PIC/S 032-1 2008年GMP修订版附件1，无菌药品制造的最重要变更解释》中对A级送风进行了定义，并对确认、监测进行了要求。该内容更有指导意义。

A级送风的定义
专门用于描述空气经HEPA过滤后，在送风处能够达到欧盟附录1中规定的悬浮粒子的要求。

A级送风的确认（qualification）：
1. 只在静态条件下测试就可以。比如，轧盖机的静态是指HEPA送风开启、轧盖机运行（但不需要放入小瓶和瓶盖）、没有操作人员干扰。
2. 必须测试悬浮粒子是否符合A级要求。探头位于HEPA后的送风处。
3. 烟雾测试必须进行。但不要求是层流状态，但必须证明背景区域（C级）的空气不能进入到A级送风区域内，从而证明小瓶是受到有效保护的。
4. 风速的标准限度应当规定，并说明理由。

A级送风的日常监测（monitoring）：
悬浮粒子和微生物的日常监测应当根据公司的风险评估确定。

梦缘

学习了，谢谢楼主，很详细