洁净空调系统验计划(英文版).doc

Qualification Plan for AHU11 System Project Name Extension of Film Facility HuaiRou Project No. BJMCFP201003 Plant / Building Huai Rou / PCM2 Unit HVAC Equipment AHU11 Document Code BJMC_02_01_AHU11_QP_1.0 Revision 1.0 Name Signature Reason Function/Department Date Signature Mark Hu Author Project Manager Li Xiao sheng Approval Technology Manager Chen Hui zhong Approval Construction Manager Su jingge Approval Construction Supervisor Reason for Change Revision Date Author Remarks 1.0 2010 03 27 Mark Hu New document Short Description of Project / Facility / System Project Description This Qualification Plan defines the qualification activities, procedures, and responsibilities for the HVAC System AHU11, as part of the overall qualification effort for the “Extension of Film Facility Huai Rou” of Beijing Austar Pharma Packaging Material Ltd., BJMC. For general information, see the following documents in its current version: BJMC_MRS_HVAC_AHU11/12_URS_1.0 Functional Description The film blow workshop is classified as a cleanliness room of ISO level 7 ,Class 10,000 compliance with China GMP , which comprise the following rooms: The first floor of Extrusion Room1 Roller Room2 Cutting Room3 AHU11 is supplied with fresh air from outside, first recirculation air is used to air mix section, second recirculation air is used after cooling coil, and further air treatments within the AHU11 are in the following way: Primary filter G4 AHU Cooling coil AHU Electric Heating AHU Humidifier AHU Fan AHU Silencer AHU Filter F7 AHU For the return air from AHU11 will be treated in the following way: First recirculation air AHU Second recirculation air AHU Outside For detail information, refer to AHU11 PID Doc. No. BJMC_02_01_AHU11_PID and Function Specification Doc. No. BJMC_02_01_AHU11_FS in its currents version. Main Emphasis on Quality Critical Issues GMP Risk Assessment In the URS for HVAC System Doc. No. BJMC_MRS_HVAC_AHU11/12_URS_1.0 , each re