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. 9.0 10.0 13.0 20 21 PCU1 AIC 1 PCU2 AIC 2 ------

Function packaging Sampling Material lock Washing New Warehouse

New Conditioned Storage Area Inlet to AHU Air Inlet Inlet to AHU Air Inlet Canteen

Servicing areas

Sampling Cabin A-907 with Personnel Lockers 905, 906 Material Entry A-910 Material Air-Lock A-306

Washing Area A-314.1, Equipment storage room A-314, PW Plant Room A-316

Receiving/Dispatch Area A-804, High Rack Storage Area A-806 New Conditioned Storage Area 932

Central fresh-air pre-conditioning unit Fresh-air Inlet Chamber 1

Central fresh-air pre-conditioning unit Fresh-air Inlet Chamber 2 Canteen

A-320 Airlock, A-322 Clean store, ,A-324 Dirty Equipment,A-326 Washing,A-328 Drying,A-330 Breached material store, A-332 Emergency Shower,A-334 Change room, A-918 Dispensed batch store, A-921 Dispensing room 1, A-922 Dispensing room 2,A-924 Dispensary material store,A-928 Pallet transfer.

New HVAC system is used for production area step by step A-602 Blending room,A-604Storage,

Covers Corridor A-612 Compression corridor,A-608 Compression room 1,A-610 Compression room A-616 , Compression room A-618

Covers A-628 Coating, A-628.1 PersonalAirlock, A-630 Control room, A-632 Printing, A-634 Bulk storage.

Clean Stair1 A-238, Clean Stair 2 A-240 : operated zone 2 Shoe Change A-238 : operated zone 2 Clean Change A-232 : operated zone 4* Rooms A-230, A-234 : operated zone 4* Rooms A-222, A-226 : operated none zone** Rooms A-224, A-228, A-228.1 : operated none zone Note:

*: AHU17 is designed for Zone 2(A-232, A-234, A-230), the operation

mode of the rooms are defined as listed above.

**: AHU17 is designed for Zone 3(A-222, A-226), the operation mode of

the rooms are defined as listed above. Clean Stair1 A-140 : operated zone 2 Shoe Change A-136 : operated zone 2 Clean Change A-132 : operated zone 4* Rooms A-130, A-134 : operated zone 4* Rooms A-122, A-126 : operated none zone** Rooms A-124, A-128, A-128.1 : operated none zone Note:

*: AHU17 is designed for Zone 2(A-132, A-134, A-130), the operation

mode of the rooms are defined as listed above.

**: AHU17 is designed for Zone 3(A-122, A-126), the operation mode of

the rooms are defined as listed above.

Zone 2 Zone 4 Zone 3 Zone 2 Zone 4 Zone 4 N/A N/A N/A N/A N/A

AHU11 Dispensary Zone 2

AHU12 AHU14 AHU15 AHU16

Clean corridor Granulation Suite Compression

suite Coating,

Zone 2 Zone 2 Zone 2 Zone 2

AHU17 Clean Change Zone 2

Primary

Primary packaging room A-710, A-720, A-730, A-740.

packaging area Secondary

AHU19 Packaging Area, A-407, Packaging Waste Air Lock, A-409.

packaging area

AHU20 Warehouse

AHU21

Warehouse Conditioned Storage, A-932.

New wash bay, Rooms A-624 Equipment drying room, A-620 Dirty

AHU22

Process area equipment room.

AHU18

Zone 2 Zone 3 Zone 4 Zone 4 Zone 2