制药验证文件-洁净空压机验证方案(英文版)

Qualification Protocol for New Air Compressor (COMP04)
1. Short Description of Project / Facility / System
1.1 Project Description
As part of the “Extension of Production Facility, ChangPing” Project (EPCP, No. CNPHCP200502), a new Air Compressor COMP04 will be installed in the existing utilities area for the complementary production of compressed air.
For general information, reference is made to:
EPCP_11_06_INFRA_URS (current version)
●INFRA URS,
EPCP_01_00_HLD_URS (current version)
●Project URS,
EPCP_01_00_HLD_QMP (current version)
●Project Qualification Master Plan,
EPCP_01_00_HLD_QNA (current version)
●Qualification Need Assessment,
●Functional Risk Assessment EPCP_11_03_CA_FRA_2.0
EPCP - CR 0238
●Change request (new compressor)
1.2 Functional Description for the ZT compressor with IMD dryer.
NB. For the complete functionality of the CA system refer to the functional specification EPCP_11_03_CA_FS in its current version.
Air drawn in through air filter (AF) and the open inlet valve of the unloader assembly (UA) is compressed in the low-pressure compressor element (El) and discharged to the intercooler (Ci).
The cooled air is further compressed in the high-pressure compressor element (Eh) and discharged through the pulsation damper (AS) and the after cooler (Ca).
A check valve (CV) is provided downstream of the pulsation damper (AS).
When the compressor switches to unload operation, the air trapped in the pulsation damper and the high-pressure element is blown off via the blow-off silencer (US).
The check valve (CV) prevents compressed air downstream the check valve to be blown off.
Flow diagram
AF Air filter (1) IMD bypass valve M4 Gear motor, IMD AS Pulsation damper (2) IMD air inlet valve EWD Electronic
CV Check valve drain, inlet air
US Blow-off silencer (3) Demister
Ca After cooler with integrated drain (4) Nozzle Car Regeneration air cooler, IMD collector (5) IMD outlet valve FN Fan, regeneration air IS Inlet silencer cooler to air outlet valve (customer’s
UA Unloader assembly installation)
EWDa Electronic drain, after cooler (6) Rotor, IMD
OP Oil pump (7) Regulating valve regeneration air
Ci Intercooler with integrated drain collector
GC Oil sump (gear casing)
EWDi Electronic drain, intercooler
Co Oil cooler
Eh High-pressure compressor element
OF Oil filter
El Low-pressure compressor element
FN1 Cooling fan (ZT)
1.3 Main emphasis on quality critical issues
1.3.1 GMP Risk Assessment
The air compressor installation will be in compliance with the valid Project Qualification Master Plan, Doc. No. EPCP_01_00_HLD_QMP, EPCP_11_03_CA_FRA in their current version.
1.3.2 Critical measurement instruments
Instruments for : Operating pressure, Dew point and Temperature.
1.3.3 Critical items/functions
Specification for construction material of operational parts.
Air drying process.
1.3.4 Qualification strategy
The air compressor qualification is covered by the following documents:
URS,
GMP and Functional Risk Assessment
Qualification Protocol (QP)
DQ, IQ & OQ
Qualification Report (QR).
Notes:
1. No separate CSV Qualification Protocol and Qualification Report are needed since it
is a Class 4 system.
2. A 21CFR Part 11 Risk Assessment is not requested because the control system is not
able to store any data.
3. The air compressor and its auxiliaries will be commissioned with the support of a
Vendor Engineer.
5. T he Qualification (DQ/IQ/OQ) will be prepared by BNP’s own Engineers, based on
this QP. The Qualification Documentation will be prepared by Luwa.
6. The calibration during IQ will be executed by the vendor technician supervised by
BNP R&M engineers.
7. The qualification strategy and tests scope will be based on the qualification of the
existing air compressor (same supplier, same type). No new GMP and Risk Assessment will be prepared.
2. Steps covered in this Protocol
For the Qualification of the air compressor, the present QP will be followed. The qualification documents for the air compressor will be created (DL and DQ, IQ, OQ) and will be filed with this qualification.
NB: This Qualification plan does not include interfacing utilities. For information about the qualification of the CA system, see EPCP_11_03_CA_QP in its current version.
Design Qualification (DQ): yes: no: NA: Commissioning (GEP) 1): yes: no: NA: Installations Qualification (IQ): yes: no: NA: Operational Qualification (OQ): yes: no: NA: Operational Qualification (PQ) 2): yes: no: NA:
1) Only FAT and correct installation before IQ (SAT)
2) PQ will be done by checking the Pressure and microbial test at the exhaust of the new air compressor. No water content testing will be made as the dryness and oil free status is certified by the manufacturer.
Copies of the certificates will be filed in the qualification binder.
3. Documentation
3.1 Qualification Documents List (GPE_FRM_511_0071)
Refer to “Qualification Document List for the air com pressor, EPCP_11_03_CA_COMP04_DL” in its current version.
3.2 Project Specific SOP’s
No project specific SOPs for the commissioning execution of this new air compressor.
3.3 Administration of Documents
The Documents are filed according to “Document Management Syst em:
Doc. No EPCP_01_00_HLD_DMS” in its current version.
4. Basics
4.1 Basic SOP’s
GPE_SOP_508_0484: Concept for Commissioning and Qualification
EPCP-SOP-001: Commissioning
GPE_SOP_511_0042: Specification, Execution and Deviation Resolution of Tests
GPE_SOP_511_0030 Handling of Changes (Engineering Projects)
4.2 Project Specific Agreements
Two types of training activities will be conducted one training for qualification execution and an other training for operation and maintenance.
Qualification execution training is mandatory for all persons taking part in the qualification work. The training will be conducted by Luwa, and each test person shall complete the training before the empowerment to execute qualification and commissioning activities. Operation and maintenance training will be conducted by the EPCP or the vendor. Luwa operators, engineers or technicians should complete the training based on the functional requirements.
Luwa Persoamal Training Record (FRM_000037) and Training Record (FRM_000039) will be used to document the training.
5. Qualification Activities (Action Plan)
5.1 Project Time Schedule
Refer to project time schedule in its current version.
5.2 Qualification Activities (included in Project Time Schedule)
All qualification activities are summarized in “Section 1.3 Main emphasis on quality critical issues”, “Section 3.1 Qualification Documents List”.
6. Organization / Responsibility
6.1 Qualification Organization
Refer to “Qualification Master Plan, EPCP_01_00_HLD_QMP” for responsibilities matrix. 6.2 Project Organization
The organization is within the current EPCP organization chart in PPM.
7. Attachments to Protocol
Attachment 1 Qualification Document List for air new compressor,
EPCP_11_03_CA_COMP04_DL in its current version.。