ABCD级的换气次数最低分别是多少？参照什么标准？

linux407

ABCD级的换气次数最低分别是多少？参照什么标准？

崔云龙521

A级只有风速要求。

制药企业小菜鸟

FDA行业指南
无菌工艺生产的无菌药品cGMP（2004）
说D级每小时达到20次是可以接受的

linux407

没人回答吗

Empty丶

2010年 药品GMP指南：厂房与设备 P377

linux407

怎么现在有人说B级最低50，C级最低25，D级最低15？

尼古拉斯-赵四

linux407 发表于 2019-8-20 12:54
怎么现在有人说B级最低50，C级最低25，D级最低15？

说又不犯法，随便怎么说都可以啊！关键是他们拿不出证据

山顶洞人

linux407 发表于 2019-08-20 12:54
怎么现在有人说B级最低50，C级最低25，D级最低15？

谁说的谁出来解释！

来自安卓APP客户端

wpnman

Much has been made of the importance of “air change rate” (volume of air/hour ÷ room
volume) or “ventilation rate”, the number of times in an hour that the air volume of a room is
replaced. Little is said about the relationship between these rates and the classification of the
space, recovery rates and the more important issue of total volume of ventilation.
When considering the design of classified space, designers will often first consider the
requirement for 20 Air Changes/hour (AC/hr), expressed in the 1987 FDA Sterile Guide. In
lieu of calculating the airflow required by the process, many will default to “rules of thumb”
for ventilation rate by the class of space, typically in the ranges:
z 15-20 AC/hr for Controlled, Not Classified (CNC) spaces
z 20-40 AC/hr for Grade 8 (EU Grade C)
z 40-60 AC/hr for Grade 7 (EU Grade B)
z 300-600 AC/hr for Grade 5 (EU Grade A)
出自ISPE HVAC 2.3.6 Total Airflow Volume and Ventilation Rate

1622579739

参照国家标准制定自己的标准，但标准必须高于等于国家标准

依然星期三

崔云龙521 发表于 2019-8-20 12:17
A级只有风速要求。

有理有据，令人信服

来了就好

B级40,C级25 ,D级15

马穆路

有理有据，令人信服

SpringShi

顶一下，又有没有大师更新？

平凡的人生

。。。。。。。。。。

Serenity

YY 0033-2000 无菌医疗器具生产管理规范

1433240751

D级，部分房间≥6合理吗？

新手小白1

1433240751 发表于 2022-7-7 17:17
D级，部分房间≥6合理吗？

至少是15次

九五二七

linux407 发表于 2019-8-20 12:54
怎么现在有人说B级最低50，C级最低25，D级最低15？

验收指南的要求  平时不是

九九emj

When considering the design of classified space, designers will often first consider the
requirement for 20 Air Changes/hour (AC/hr), expressed in the 1987 FDA Sterile Guide. In
lieu of calculating the airflow required by the process, many will default to “rules of thumb”
for ventilation rate by the class of space, typically in the ranges:
 15-20 AC/hr for Controlled, Not Classified (CNC) spaces
 20-40 AC/hr for Grade 8 (EU Grade C)
 40-60 AC/hr for Grade 7 (EU Grade B)
 300-600 AC/hr for Grade 5 (EU Grade A)