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

No. AHU24

Function Process area Sampling

Servicing areas Granulation, Covers A-638 Material Airlock, A-640 Personal Airlock, A-636 Granulation room, A-642 Emergency Shower. Zone 2

Rooms A 820, A 821, A 822, A823, A 824

4

4.1

Procedures

Sequence of Existing Systems Start-up

All the HVAC systems are continuously running, 24hours/day, except the AHU 9.0 system for the Sampling Room (see SOP-000213 Operation and Cleaning for Sampling Cabin (R907) in Warehouse ) and future Sampling Cabin served by AHU 25. In case of maintenance activities requirements or system failure, the system can be shut down in accordance with the SOP-000328.

The room Pressure status Representation (Image 1) shows the pressure cascade of the production area. In principle, The HVAC systems should be started-up from the higher pressure area to the lower pressure area to ensure the correct air flow direction, which defines the HVAC and the related production area start-up sequence.

The PCU1 and PCU2 units are always in operation, because they supply with pre-conditioned air to the Air Handling Units in all buildings (e.g. existing and New Extension Production Building 12A, 13, etc.). The adjustments for the various air volume amounts is controlled automatically by the DDC system. No further activities are necessary. Start up sequence:

Step 1: 40Pa’s areas, including

AHU 2.3 (Emugel Processing Area) AHU 2.2 (Emugel Filling Area)

Step 2: 39Pa’s areas including

AHU12 (Clean Room Corridors A 600 & A 700)

AHU 11 (serving rooms on 39 Pa level: materials airlock A 320, dispensed batch store A 918, dispensary store A 924 plus rooms on lower pressure level) 30Pa’s areas, including

HVAC system 1.1 (Clean Room corridors A 300 & A 500 plus Production Rooms on lower pressure level)