OPERATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT

OPERATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM

TABLE OF CONTENTS

  • Pre-Approval
  • Overview
    • Purpose
    • Requalification
    • System Distribution
    • System Description
  • Operational Qualification Procedure
    • Pre Requisite for OQ Test
      • Test Equipments
      • Qualification of Execution Team
    • Inspection Checklist
    • Operational Qualification
      • Instrument Calibration
      • Key Functionality
      • Operational Checks
      • SOP verification
      • Deficiency, if any and Corrective Action Report
    • Acceptance Criteria
    • Summary and Conclusion
    • Appendix
      • Abbreviations
    • Certification for Operational Qualification

Pre-Approval

Signing of this Approval page of Operational Qualification for AHU indicates agreement with the Operational Qualification approach described in this document. If any Modifications become necessary, an addendum will be attached.

Overview

Purpose:

The purpose of this protocol is:

  • To verify the operational attributes of the Heating Ventilation and Air Conditioning system, critical to serve the intended purpose.
  • To establish the suitability of the draft SOP prepared for the operation of System.
  • To document the observations for future reference.

Re-qualification:

Operational Qualification to be repeated in case of:

  • Replacement of any major component / instrument.
  • Major modification in the existing equipment.
  • During monitoring if equipment is found to be malfunctioning (Broken or not working properly).
  • Shifting of the equipment from one location to another location.

System Description

The Air Handling Unit  consists of:

  1. Air Circulation System
  2. Air Cooling System
  • Air Distribution Network
  1. Air Filtration System
  2. Control System
  3. Safety System

FUNCTION: The AHU is designed to circulate the air in the area after passing it over cooling coils to maintain the required environmental conditions and passing it through the series of filters to maintain desired cleanliness level in the area. The air in-take and out-take of the system is designed to maintain certain degree of pressure gradient, temperature and Relative Humidity in the area as per the requirement.

The major components of the air-handling unit are briefly described as below:

Air Circulation System

Blower: – Blower is provided in the unit to supply air in the working area. This blower is direct driven by a motor. The blower takes the air from the atmosphere and / or from the rooms as return air and delivers it to the working areas through air distribution network

Air Cooling and Heating System

Cooling Coil: –The air Temperature and RH should be controlled by cooling coil. It has Coated Al.fins and Chilled water circulated through coil by copper tubes. The Dry air passing through coil before entering in room via ducting system.

Hot water Coil: –The air Temperature and RH should be controlled by HW coils. It has Coated Al.fins and Chilled water circulated through coil by copper tubes. The Dry air passing through coil before entering in room via ducting system.

Air Distribution System

Air Distribution Network An air distribution network is provided to supply the air, delivered by the blowers, into the working areas. By using the same network, return air flows back to the air handling unit to maintain certain pressure gradient and other parameters like Temperature & RH.

AIR FILTRATION SYSTEM

10 micron Pre Filters: – Fresh air filters having filtration efficiency upto 90% down to 10m are provided in the Fresh air intake of the AHU to filter out dust particles from the service area air.

0.3 micron HEPA Filters: – HEPA filters having filtration efficiency up to 99.99% down to 0.3m are provided in the Air Handling Unit for bleed air.

10+5 micron combo Pre Filters: –Combo pre filters having filtration efficiency up to (90% down to 10 m + 95% down to 5m) are provided before cooling coil in the return air of the Air Handling Unit to filter out the dust particles.

3 micron Fine Filters: – Fine filters having filtration efficiency up to 99% down to 3m are provided after the cooling coil and blower to remove fine particles from the treated air.

CONTROL SYSTEM

Instrumentation and Control System: – For the purpose of controlling of various parameters, Proportional thermostat have been provided.

The Air-Handling unit caters to:-

AREA DETAILS 
Sr. NoName of the areaArea (SQFT)Height (FT)
1Sampling1489.84
2Wash419.84
3Change Room599.84
4Sampling1499.84
5Air lock779.84
6Sifting1629.84

The Air Handling unit is designed to provide and maintain the following conditions in the area where it caters

  • AHU Capacity of air filtration —          2718 CFM.
  • Temperature —          NMT 25 ºC
  • R H                      —        NMT 60 %
  • Operational Qualification Procedure

Pre Requisite of OQ Test

  • Equipment should be installed properly as defined in Installation Qualification Protocol of the equipment.
  • Utilities should be provided to the equipment.
  • Required identification tags should be available at site in appropriate place.

Test Equipment

Following test equipments are required for Operational Qualification Test.

Test EquipmentPurposeCalibration RequiredDone onDue onCalibration Confirmed By
Magnehelic GaugeFor checking the Pressure Drop across the AHU FiltersYes
Multi Meter / Clamp Meter.For checking the Electrical Supply and Current rating of the motors.Yes
  • Inspection checklist
  • The SOP shall be drafted and verified for operation during Operational Qualification testing. If any changes / modifications are found SOP shall be revised considering all changes.
  • Prior to the Qualification test, the Personnel shall be trained by the competent Engineer from the supplier / user on the operational features of the equipment / system and method of qualification protocol. This training shall be recorded.
  • The trained personnel shall carry out the Operational Qualification following the Procedures mentioned  for key functionality and safety features. Record the observations in the individual test data sheets. Checkpoints designed for the purpose of OQ are also aimed at verification of existing and drafted SOPs.
  • Report the deficiency from the specified function, if any in the protocol.
  • Operational Qualification
    • Instrument Calibration
S. No.Name of the EquipmentLocationCalibration Done onCalibration Due onCalibrated By
Magnehelic gauges

Key Functionality

The critical components of the Air Handling System shall be checked to ensure that these are operating to meet the desired design specification, as given by the supplier.

The following attributes are considered as critical

  • Primary Checks of Blower and Motor Assembly
  • Operation of Blower Motor Assembly
  • Operation of Cooling and Heating system
  • Flow of air through filters
  • Safety Function

Operational Checks

S. No.Test ParticularsSpecified FunctionObservationsChecked By
1Primary Checks
1.1   Check for the Supply Blower and Motor of Air Handling Unit
1.1.1Check the Supply Blower and Motor assembly for proper fitment on base frame.Blower and Motor should be properly fitted on base frame and tightened with bolts and nuts.
1.1.2Check the motor shaft rotation, manually.Motor shaft should rotate smoothly when rotated manually.
1.1.3Check the Blower rotation, manually.Blower should rotate smoothly when rotated manually.
1.1.4Check the motor shaft key and hub screws.Motor should be tightened with shaft key and hub screws.
1.1.5Check the Blower shaft key and hub screws.Blower should be tightened with shaft key and hub screws.
1.2 Check for Air Handling Unit Dampers
1.2.1Open and close the Fresh Air damper of the Air Handling Unit for its operation, manually.

Note: Adjust the damper in full open condition after the checking.

Damper should open and close smoothly.
1.2.2Open and close the supply air Volume control Damper of the Air Handling Unit for its operation, manually.

Note: Adjust the damper in full open condition after the checking.

 

Damper should open and close smoothly.

 

S. No.Test ParticularsSpecified FunctionObservationsChecked By
2  Operational Checks
2.1  Check for the Power supply
2.1.1Switch on the main power supply to the control panel Located at Ground Floor.Power supply indicator should glow in the control panel
2.1.2Switch on the control panel power supply to the Air Handling UnitAir Handling Unit blower motor should start.
2.2 Check for the Supply Air Blower
2.2.1Check the supply air blower for any abnormal soundThere should not be any abnormal sound in the supply air blower.
2.2.2Check the direction of the rotation of the blower.Blower should rotate as per the arrow mark indicated on the blower.
2.3 Check for the AHU Filtration System
2.3.1Check the differential pressure of the 10+5 m filtersDifferential pressure of the filters should be between   4-12mm of wc
2.3.2Check the differential pressure of the 3 m filtersDifferential pressure of the filters should be between  12-15mm of wc

SOP VERIFICATION

SOP No.          : _____________________

Title                 : _____________________

The System was operated as per the SOP and details are recorded as under:

Operated By:   _____________________________________

Checked By:    _____________________________________

Changes required in draft SOP (If any): ____________________

SOP to be corrected (Yes/No)            : ____________________

Verified By                             : ____________________

Date                                        : ____________________

Acceptance Criteria  

Operational Qualification shall be considered acceptable when all the conditions specified in various above test data sheets  have been met.

Any deviation from the acceptance criteria of the specific checkpoint shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment / component.

ChecksObservationsChecked by
Whether the acceptance criteria of the protocol and specific checkpoints are met.

SUMMARY AND CONCLUSION

Appendix

6.1          ABBREVIATIONS:-

 

Sr. No.TermExplanation
1AHUAir Handling Unit
2DQDesign Qualification.
3IQInstallation Qualification
4OQOperational Qualification
5GIGalvanized Iron
6SSStainless Steel.
7TempTemperature
8RHRelative Humidity
9ACPHAir Changes per Hour.
10CFMCubic Feet per minute
11MOCMaterial of construction
12Cont.Continued
13WCWater column
14SOPStandard Operating Procedures
150CDegree centigrade
16mMicron
17cGMPCurrent Good manufacturing practices
18MinMinimum
19MaxMaximum
20NMTNot more than
21NLTNot less than
22NANot Applicable
23EPSExpanded polystyrene
24DXDirect Expansion
25HEPAHigh efficiency particulate air.

ABBREVIATIONS (CONTD.):-

Sr. No.TermExplanation
26FPIFins per Inch.
27ADPApparatus dew point
28ISOInternational Organization for Standardization.
29URSUser requirement specification
30Q. A. HeadQuality Assurance Head
31VCDVolume Control Damper.
32GSSGalvanized sheet steel
33AL.Aluminium
34NRNot Required
35DIDWDouble Inlet Double Width
36DBDry Bulb
37FLPFlame Proof
38KWKilo Watt
39HPHorse Power
40PhPhase
41Sq. Cg.Squirrel Cage
42PaPascal

CERTIFICATION FOR OPERATIONAL QUALIFICATION

 

The system is now ready FOR PERFORMANCE QUALIFICATION