瑞士诺华制药为世界制药行业领导者,2013年排名全球第一。本文为北京诺华制药洁净空调操作规程,通过GMP、FDA、TGA审计,供同行借鉴参考学习。

空调系统操作程序

Step 3: Low pressure production areas (26Pa), including

AHU 14 (serving Blending & Storage)

AHU 15 (serving Clean corridor A 612 and compression rooms on lower pressure level) AHU 16 (serving Coating)

AHU 17 (serving Zone 2 change lockers) AHU 18 (serving Primary packaging) AHU 22 (serving new wash bay area)

.AHU 24 (serving granulation air locks A 638 & A 640 and granulation room on lower pressure level)

Low pressure production areas (25Pa)

AHU 2.1 (serving locker A 507 and capsule filling room at lower pressure level)

Low pressure production areas (20Pa)

AHU 8.0 (serving Room A 302 and A 304)

AHU 10.0 (serving Material Air lock A 910 & A 306)

AHU 13.0 (serving room A316 and washing area at lower pressure level)

Low pressure production areas (13Pa) AHU19 (Secondary packaging area)

Low pressure production areas (10Pa) AHU 10.0 (material lock)

AHU 3.0 (secondary packaging area)

Notes:

In case of HVAC systems start-up, all the room related Spot Suction systems

(e.g. dispensing room, granulation room, compressing rooms, primary packaging rooms, etc.) must be in operation at the same time.

After any HVAC is stopped the time interval from re-starting the HVAC system

supplying room air into GMP Zones 2 for production re-start should be at least 30 minutes to ensure clean rooms recovery conditions.