洁净空调启停操作规程-诺华制药

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。

HVAC System Operation Procedure

SOP-000309 Version : 04

Effective from : 24.10.2008

空调系统操作程序

Approvals 批准: Name 姓名:

Date 日期:

Signature 签名

:

Approvers 批准人:

Final Approver 最终批准人:

Applicability: document applies for Beijing Novartis Pharma Ltd. 适用于：文件适用于北京诺华制药有限公司

All PlantProductionEngineeringother :

QCProcessingSCM

QAPackagingBPA

HR/Admin.Semi Solid

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。

HVAC System Operation Procedure

空调系统操作程序

Replaces No.: SOP-000309 version 02 Reason for Change: 1.

Integration of all HVAC Units of EPCP in operation.

1

Regulatory Basis and Reference Documents

Novartis Quality Manual: Module N6.2: Cleanliness Zoning

IGs N6.2.2: Cleanliness Zoning Policy for The Manufacture of Non-Sterile Drug

Products and the Respective Drug Substance

BNP SOPs:

SOP-000066: Filter Replacement for HVAC Installation

SOP-000192: Room Monitoring Cleanliness Zoning parameters P Pa, T℃, RH % SOP-000213: Operation and Cleaning for Sampling Cabin (R907) in Warehouse SOP-000217: Preventive Maintenance for HVAC Units

SOP-000328: General Operating Procedures in case of HVAC Shut Down SOP-000390: Cleanliness Zoning

SOP-000475 Room Condition Monitoring in case of RMS fails (none availability) NB. Upon approval of the RMS SOP these SOPs will be referenced to this SOP.

2 Purpose

To specify the general sequence of HVAC system start up and shut down. To specify the general instructions on how to operate the HVAC systems.

3

No. 1.1 2.1 2.2 2.3 3.0 4.0 5.0 6.0 8.0

Scope

This SOP is valid for all the following production related HVAC systems in Beijing Novartis Pharma. Ltd, ChangPing.

Function Production area Capsule filling Emugel filling Emugel processing Packaging N/A Lockers QC Alu-Alu

Servicing areas Dispensing A-308, Day storage Room A-310, Blending Room A-313, Intermediate Storage A-504, Granulation Room A-506, Compressing Rooms A-508.1, Compressing ante-room A-510, Capsule filling room A-Zone 2

508.2, Coating Room A-514, Coating drying room A-516, Corridors 300 and 500 etc.

Encapsulating A-511, Printing A-509 and locker 507 Zone 2 Cream/Ointments Filling A-505 and Personnel Lockers 505.1, 505.2,

Zone 2

505.3, 501.1

Cream/Ointments Processing A-503 and locker 501, Storage room 503.1 Secondary packaging A-405,Air locker 405.1 etc. N/A

Offices and Production Lockers QC Laboratories

Alu-Alu Blister Packing A-302, Compressing Room A-304

Zone 2 Zone 2 Zone 3 Zone 2 Zone 4 Zone 2

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

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)

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.

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