跨国制药企业HVAC系统IQ方案

INSTALLATION QUALIFICATION PAGE 1 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 INSTALLATION QUALIFICATION OF THE LINE 9 AHU 20 20A HVAC SYSTEM ZYDIS PRODUCTION FACILITY No 2 Compiled by R Sanders Scope This protocol details the IQ work required to validate the new HVAC system for Line 9 Zydis production facility No 2 ApprovalsSignatureDate Validation Quality INSTALLATION QUALIFICATION PAGE 2 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 1SYSTEM DESCRIPTION HVAC system 9 is a fixed fresh air recirculating type system has been installed as part of the Line 9 in the Zydis Production Facility No 2 and serves the production areas indicated in the table below Note This line is also referred to in some documentation as Xtraline HVAC System 9 AHU 20 20A Room AreaTitle G380Production Corridor G381Airlock G384Freeze Dryer Plantroom Airlock G382Freeze Dryer Load Unload G385Production Area G386Airlock G387Warehouse Production Airlock Make up air is drawn into the primary Air Handling Units AHU passing through an electric pre heater bag Filter EU4 pre cooling coil and bag filter EU8 before passing on to the de humidifier unit and secondary AHU The de humidifier unit is installed on a fixed flow bypass ducting off the main ductwork between the primary and secondary AHUs and processes only a proportion of the main air flow In the secondary AHU the air passes through a further electrical heater a cooling coil a pleated filter EU8 and attenuator before final distribution through ductwork and dampers into the rooms Extract air from the rooms passes through an attenuator before re entering the primary AHU to be re circulated around the system The production area is also served by two independent room extracts for the seal station and the freeze tunnel which discharge outside the building INSTALLATION QUALIFICATION PAGE 3 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 2SPECIFICATION Collate together all documents which relate to specifying and procuring this equipment This will normally include some or all of the following documents Quotation from supplier Order to supplier Acknowledgment from supplier Variations to the order and any acknowledgments Tender documents Work packages etc Attach the documents listed as appendices where practical For documents which are not attached give the reason below the table and a reference as to where the document is available TYPE OF DOCUMENTREFERENCE OF DOCUMENT DATE OF DOCUMENT APPENDIX NO Comments Completed byDate INSTALLATION QUALIFICATION PAGE 4 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 3PRE QUALIFICATION HISTORY List below all tests modifications made to the equipment or its design during and as a result of installation and commissioning Record the reason for each modification and define the updated technical data drawings specifications etc TESTS MODIFICATIONSREASON Comments Completed byDate INSTALLATION QUALIFICATION PAGE 5 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 4SAFETY List in the table below all safety features e g interlocks emergency stops etc incorporated into the HVAC System FEATUREFUNCTIONLOCATION Comments Completed byDate INSTALLATION QUALIFICATION PAGE 6 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 5 SYSTEM SPECIFICATION 5 1Inspect the system installation and confirm that the following specified requirements have been met Specification Requirement Complies with spec Signature Date Comments Ductwork Supply and recirculation ductwork insulated Yes No Insulation Circular ducts up to 350mm diameter Rigid phenolic foam sections with factory applied aluminium facing foil Yes No Insulation all other duct sizes Rigid phenolic foam laminate board with reinforced aluminium foil facing Yes No Flexible ductwork insulated with mineral fibre Yes No The dehumidifier process exhaust ductwork installed in stainless steel Yes No All rigid ductwork shall be made from hot dip galvanized sheet Yes No Access covers shall be located adjacent to all fire dampers volume control dampers heating cooling coils and filters Yes No Completed byDate INSTALLATION QUALIFICATION PAGE 7 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 5 1System Specification continued Specification Requirement Complies with spec Signature Date Comments Test holes sealed with removable resealable plugs Yes No Flexible ducts used to join rigid ductwork to terminals Yes No Internal duct work clean Yes No All manually set dampers have a lockable visual blade position indicator Yes No Dampers installed for balancing or control shall be galvanized steel Yes No Ductwork correctly labelled with direction of flow Ductwork colour coding Fresh air Green triangle with FA notation black on triangle Supply air Red Blue triangle with SA notation black on triangle Recirc air Grey triangle with RA notation black on triangle Exhaust air Brown triangle with EA notation black on triangle Yes No Yes No Yes No Yes No Completed byDate INSTALLATION QUALIFICATION PAGE 8 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 5 1System Specification continued Specification Requirement Complies with spec Signature Date Comments Air Handling Units AHU AHUs Modular frame construction with double skinned thermally insulated panels Each section labelled with engraved traffoylte nameplate of unique reference Yes No AHUs fitted with readily removable panels to provide internal access to the unit with key operated positive latches Large panels hinge mounted Yes No Primary filters in AHU mounted on slide rails to allow side withdrawal with suitable access upstream and downstream as required Yes No Each filter bank fitted with 0 500pa magnahelic gauge Yes No3 filter banks in total Bottom of cooling coil case fitted with water tight drip tray in stainless steel with drain connection Yes No Cooling coil casing bolted to full width diaphragm plate and slide rail mounted for ease of withdrawal and distortion Yes No Cooling coils fitted with binder type test point on inlet and outlet high level air vent and low level draincock on pipework connections Yes No Cooling coil pressure test certificates available Yes No Completed byDate INSTALLATION QUALIFICATION PAGE 9 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 5 1System Specification continued Specification Requirement Complies with spec Signature Date Comments Fans and motors frame mounted incorporating anti vibration mountings Yes No Fan pulleys belts and motor drives mounted external to the fan unit appropriate flexible joints and isolation mounts Yes No Belt drives shall incorporate a minimum of 2 belts drive with motor position fully adjustable for belt tension All adjustments are separately lockable Yes No Fan motor local isolator fitted Yes No Equipment items taggedYes No Drain points installed for cooling coil condensate with air breaks Yes No Installation reports test sheets Fire Damper Installation test sheetsYes No Fan installation test sheets Yes No Magnahelic gauge test sheets and calibration certificates Yes No Filter installation test sheetsYes No Dehumidifier air leakage test sheets Yes No Ductwork air leakage test sheets Yes No AHU air leakage test sheets Yes No Completed byDate INSTALLATION QUALIFICATION PAGE 10 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 5 1System Specification continued Specification Requirement Section 2 parts A and B Complies with spec Signature Date Comments Installation reports test sheets BEMS Air Pressure Devices test sheet Yes No BEMS Air Temp and Humidity test sheet Yes No BEMS Control Valves test sheetYes No BEMS Motorised Damper Valves test sheet Yes No BEMS Air Temperature and Humidity Devices Calibration test sheet Yes No BEMS Air Pressure Devices Calibration test sheet Yes No Completed byDate INSTALLATION QUALIFICATION PAGE 11 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 5 1System Specification continued Specification Requirement Section 2 parts A and B Complies with spec Signature Date Comments Commissioning reports and test sheets Equipment manufacturers service commissioning reports Yes No Air Distribution Systems pre commissioning sheet Yes No Air Distribution Systems Fire Damper commissioning sheet Yes No Circular Duct air flow volume pitot traverse commissioning sheet Yes No Rectangular Duct air flow volume pitot traverse commissioning sheet Yes No Air Distribution Systems terminal device air flow volume commissioning sheet Yes No Air Distribution Systems Fan commissioning sheet Yes No Ductwork static pressure profile commissioning sheet Yes No Magnahelic gauge commissioning sheet Yes No HVAC systems summary commissioning sheet Yes No Completed byDate INSTALLATION QUALIFICATION PAGE 12 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 6SYSTEM FEATURES IDENTIFICATION AND CHECKS OF THE PRINCIPAL COMPONENTS OF THE EQUIPMENT Visual Inspection The following components will be given a full visual inspection to verify that they are present as specified are correctly documented and have been installed correctly Any deviations from the specification or documentation and incorrect installations must be commented on The details indicated will be recorded for the equipment as installed 6 1Dehumidifier Supplier Munters Model No Serial No SpecificationSpecifiedInstalled Max Flow rate7 757 m3 s De humidification capacity 2 11m3 s Humidity extract system silica gel Reactivation HeaterGas powered Comments Completed byDate INSTALLATION QUALIFICATION PAGE 13 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 6 2Air Handling Unit AHU 20 Supplier Air Handling Equipment Ltd Model No Serial No SpecificationSpecifiedInstalled Fan typeCentrifugal Fan duty7 757m3 s Motor rating18 5KW Drive typeInternal motor and belts Pre filter No 1EU4 short bag NBS 80 Dimensions Type Pre filter No 2EU8 long bag NBS 95 Dimensions Type Pre heating mediumElectric Pre cooling mediumChilled water Isolation damper typeBare shaft for actuator mounting Mixing box damperManually opposed Comments NBS American National Bureau of Standards Completed byDate INSTALLATION QUALIFICATION PAGE 14 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 6 2Air Handling Unit AHU 20A Supplier Air Handling Equipment Ltd Model No Serial No SpecificationSpecifiedInstalled Heating mediumElectric Cooling mediumChilled water Final filterPleated Rigid EU8 NBS 95 Dimensions Type Comments NBS American National Bureau of Standards Completed byDate INSTALLATION QUALIFICATION PAGE 15 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 7DRAWINGS CHECK Obtain prints of the component and services drawings identify these in the table below DRAWING No DRAWING TITLEREVISION No APPENDIX No G0386 M006Production Area HVAC Schematic G0386 M002Ceiling Void mechanical Services Production Area First Floor Plant Room Clearly identify all the following 1 All corrections 2 Details not verified and the reason for non verification 3 Discrepancies between the drawing and the installed equipment 4 Details verified Annotate each drawing with the words INSTALLATION QUALIFICATION DRAWING CHECK sign and date the marked up prints when the checks are complete Also write this protocol title and reference number and the appropriate appendix number on the print Attach the marked up prints to this protocol as an appendix Comments Completed byDate INSTALLATION QUALIFICATION PAGE 16 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 8SERVICES CONNECTION CHECK Complete the details of the as fitted service supplies and comment on any discrepancies between them and those recommended by the supplier SERVICERECOMMENDEDCONNECTED Electricity415v 3 phase Natural Gas Chilled Water Comments Completed byDate INSTALLATION QUALIFICATION PAGE 17 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 9INSTRUMENTATION InstrumentRange and Tolerance Category 1 2 3 Instrument Confirmed Present Manufacturer and Model Manufacturer s Serial Number Instrument Number Damper Motor3 Belimo SN21MS14001 00612 Coil Freeze Protection Thermostat 3 MS14002 00613 Air Differential Pressure Transmitter 0 1000 pa 3 MS14003 00614 Air Temperature Transmitter3 MS14004 00615 Air Differential Pressure Transmitter 0 1000 pa 3 MS14005 00616 Air Temperature and Humidity Transmitter 3 MS14006 00617 Air Differential Pressure Transmitter 0 1000 pa 3 MS14007 00618 Air Temperature Transmitter3 MS14008 00619 Air Differential Pressure Transmitter 0 1000 pa 3 MS14009 00620 Air Temperature and Humidity Transmitter 3 MS14010 00605 Completed byDate INSTALLATION QUALIFICATION PAGE 18 OF 21 Line 9 AHU 20 20A HVAC System IQ0348 InstrumentRange and Tolerance Category 1 2 3 Instrument Confirmed Present Manufacturer and Model Manufacturer s S