HVAC validation protocol

Please let me know how to perform a complete HVAC validation? requirements, protocol, report, etc
I need a sample of HVAC validation protocol

Hi
Farzan
For qualifying HVAC system you need have Complete URS (User Requirement Specification)
Then DQ,IQ,OQ and PQ shall be performed.
Design qualification should cover not limited to below mentioned
SCOPE
REASON FOR DESIGN QUALIFICATION
ABBREVIATIONS
OVERVIEW
RESPONSIBILITY
EQUIPMENT DETAILS
EXECUTION TEAM MEMBERS
DESIGN QUALIFICATION PREREQUISITES
EQUIPMENT DESIGN AND PRINCIPLE OF WORKING
DESIGN QUALIFICATION SPECIFICATION
DEFICIENCY AND CORRECTIVE ACTION REPORT
IMPACT ASSESSMENT
GxP ASSESSMENT AND GAMP CATEGORIZATION
EQUIPMENT VALIDATION REQUIREMENTS
FACTORY ACCEPTANCE TEST
SUMMARY AND CONCLUSION
APPROVAL
ATTACHMENTS

Installation Qualification should include

1.0 REVISION HISTORY
2.0 PRE-APPROVAL
3.0 PURPOSE
4.0 SCOPE
5.0 REASON FOR INSTALLATION QUALIFICATION
6.0 ABBREVIATIONS
7.0 OVERVIEW
8.0 RESPONSIBILITY
9.0 EQUIPMENT DETAILS
10.0 INSTALLATION QUALIFICATION PREREQUISITES
11.0 PHYSICAL VERIFICATION OF EQUIPMENT ON RECEIPT
12.0 PHYSICAL VERIFICATION OF AREA
13.0 VERIFICATION OF MOC AND SURFACE FINISH OF MATERIALS (IF ANY)
14.0 SOFTWARE VERIFICATION
15.0 IDENTIFICATION AND VERIFICATION OF PLC / COMPUTER / MICRO PROCESSOR
16.0 IDENTIFICATION AND VERIFICATION OF MAJOR COMPONENTS AND ACCESSORIES
17.0 DISABLEMENT OF THE DAY LIGHT SAVING TIME [DST]
18.0 IDENTIFICATION OF INSTRUMENTS REQUIRING CALIBRATION OR TESTING
19.0 VERIFICATION OF REQUIRED CHANGE PARTS
20.0 IDENTIFICATION AND VERIFICATION OF SUPPORTING UTILITIES
21.0 IDENTIFICATION OF STANDARD OPERATING PROCEDURES
22.0 PLC TIME SETTING
23.0 QRM RECOMMENDATIONS AND COMPLIANCE
24.0 DEFICIENCY AND CORRECTIVE ACTION REPORT
25.0 SUMMARY AND CONCLUSION FOR INSTALLATION QUALIFICATION:
26.0 POST APPROVAL
27.0 ATTACHMENTS

Operational Qualification shall include:

KEY FUNCTIONALITY, SAFETY FEATURES AND EMERGENCY STOP FEATURES OF HVAC UNIT
Sl. No. Key Function/ Safety
feature Function / Verification Procedure Acceptance Criteria Complies
Yes No
1 Main Panel “ON” Turn ON the main panel MCB switch for respective AHU system. Power is supplied to the AHU System, Incoming lights L1, L2, L3 glows and stop red indicator light glows on the AHU MCC or VSD panel.  
2 MCC or VSD Panel Isolator switch and green VSD Run button. Turn the isolator knob towards “MANUAL” operation mode and press the RUN button on the VSD HMI. AHU starts operations only when it is activated in BMS… Green indicator light glows.  
Turn the isolator knob towards “AUTO” operation mode and press the green RUN button on the VSD HMI AHU starts operations only when it is activated in BMS. Green indicator light glows.  
Turn OFF the isolator knob during manual or auto operation. AHU Stops operation and red indicator light glows.  
3 STOP/RESET Press Red Indicator Button. Red indicator light glows Motor “OFF”  
4 Main Panel “OFF” Turn OFF the main panel isolator switch. Power supply to the system is stopped and incoming power light doesn’t glow.  
Blower Functionality:
1 Direction of rotation Turn ON the main panel, feeder button and press green indicator push button. Clockwise / Anticlockwise  
2 Vibration Normal  
3 Noise level Should not be abnormal  
Pressure drop across filters (For information purpose only)
1 Pre Filter Observed Reading:__________________  
2 Fine/Medium Filter Observed Reading:__________________  

KEY FUNCTIONALITY, SAFETY FEATURES AND EMERGENCY STOP FEATURES OF HVAC UNIT

Sl. No. Key Function/ Safety
feature Function / Verification Procedure Acceptance Criteria Complies
Yes No
Functioning of Temperature indicator (For information purpose only)
1 Temperature indicator Limit………………(As per DQ)
Observed (…………………)  
2 Relative Humidity indicator Limit………………(As per DQ)
Observed (…………………)  
Safety Features
1 Overload Tripping
During operation of HVAC system, Simulate the overload tripping from relay When the system is overloaded it gets trip off  
2 Functioning of emergency push button & RUN Green push button at Panel / VSD Run the HVAC unit and press the emergency push button present at the Panel.
Release the Emergency button.
Press RUN Green push button provided at HMI of VSD Panel. • The HVAC system shall stop.
• The HVAC system shall not start without operator interference.
• HVAC system shall ON.

Verification of BMS Control Features
1 Start-up to BMS operation Switch ON to BMS computer and click on the login button on top right corner, enter correct user name and password. WinCC will Autostart after PC is logged in and BMS_CLIENT windows appears on entering correct username and password BMS main user screen appears with utility menu tab keys.  
2 AHU operations Click on the Air Handling Unit tab from the BMS main user screen. Air Handling unit catering to departments tab appear like tabs for Production, Warehouse, QC,
Electrical switch room and cafeteria appears.  
Click and select of the department. Tab button for AHU’s in the department gets displayed with AHU No and area name.  
Click on any of the tab button with AHU number and area name for which the AHU is catering. AHU main screen appears with complete display AHU operations in Auto mode or manual mode.
Ensure all the operating state of PID controller is in Auto mode operation and click on the START button indicated on the left bottom of the screen AHU Control AHU starts operation in Auto mode.  

KEY FUNCTIONALITY, SAFETY FEATURES AND EMERGENCY STOP FEATURES OF HVAC UNIT

Sl. No. Key Function/ Safety
feature Function / Verification Procedure Acceptance Criteria Complies
Yes No
Verification of BMS Control Features
3 Verification of temperature low warning and alarm. Simulate temperature low warning and alarm by increasing the set low temperature more than the actual. Warning and alarm gets displayed in the BMS system VSD activates to achieve the set temperature.
4 Verification of temperature high warning and alarm. Simulate temperature high warning and alarm by decreasing the set high temperature less than the actual. Warning and alarm gets displayed in the BMS system VSD activates to achieve the set temperature.
5 Verification of relative humidity low warning and alarm. Simulate relative humidity low warning and alarm by increasing the set low relative humidity more than the actual. Warning and alarm gets displayed in the BMS system VSD activates to achieve the set relative humidity.
6 Verification of relative humidity high warning and alarm. Simulate relative humidity high warning and alarm by decreasing the set high relative humidity less than the actual. Warning and alarm gets displayed in the BMS system VSD activates to achieve the set relative humidity.
7 Verification of differential pressure warning and alarm. Simulate differential pressure limit low warning and alarm by increasing the set low differential pressure value more than the actual. Warning and alarm gets displayed in the BMS system VSD activates to achieve the set differential pressure.  
8 Verification of differential pressure warning and alarm. Simulate differential pressure limit high warning and alarm by decreasing the set high differential pressure limit less than the actual. Warning and alarm gets displayed in the BMS system VSD activates to achieve the set differential pressure.  
KEY FUNCTIONALITY, SAFETY FEATURES AND EMERGENCY STOP FEATURES OF DE-HUMIDIFIER
Sl. No. Key Function/ Safety
feature Function / Verification Procedure Acceptance Criteria Complies
Yes No
1 Main Isolator “ON” Turn the main isolator to ON position. De humidifier gets power RH set value and present value get displayed.  
2 Green indicator reset OFF / ON knob Turn “ON” Green indicator reset knob Green Light glows
De Humidifier is ready for operation in manual or BMS mode.  
Turn “OFF” Green indicator reset knob De Humidifier is not ready for operation in any mode.  
3 Isolator knob for BMS / OFF / Local selection Turn isolator knob “LOCAL” position Green Light glows
De Humidifier is starts operation in manual mode.  
Turn isolator knob “OFF” position De Humidifier is not ready for operation in any mode.  
Turn isolator knob “BMS” position Green Light glows
De Humidifier is starts operation in auto mode only if BMS is logged in and is AHU is started with RH requirement.  

4 Emergency Push Button During operation press the emergency push button provided in the DHU panel.
Release the emergency push button. DH unit stops operation with all the indicators OFF.
Green Light glows
De Humidifier is starts operation in manual or auto mode.  
5 Main Isolator “OFF” Turn the main isolator to OFF position. De humidifier turns OFF.  

VERIFICATION OF POWER FAILURE & RECOVERY FEATURES
List down all the power failure & recovery features related to safety of product / person / equipment, identified during the design qualification of equipment and verify their operation.
Sl. No. Power failure/Recovery features Verification Procedure Acceptance Criteria Observation Complies
Yes No
1Run the HVAC unit and switch OFF the mains power after 2minute switch ON the main power.
Record the other observation in the remarks row. HVAC and De – Humidifier unit shall stop.
The HVAC and de-humidifier unit shall “ON” only with operator intervene.  
VERIFICATION OF OPERATOR INTERFACE, SECURITY LEVELS AND SEQUENTIAL OPERATION:
Sl.
No. Verification procedure Acceptance Criteria Observations Complies
Yes No
1.Turn ON the BMS with correct username and password for,

  1. Operator.
  2. Supervisor.
  3. Administrator/Engineer
    Try entering wrong password for the above levels. The equipment shall
     Accept correct username and password as per each level in SOP/Manual.
     Machine shall not accept the wrong username or password and shall prompt to re login.  
  4.  Run the AHU with in a normal operating range with minimum and maximum set parameters if applicable as defined in the SOP.	The AHU shall run smoothly as per the set parameters.		
    

Performance qualification to be carried out in two phases as follows
PHASE-1: All tests in rest condition shall be carried out in phase-1 these test includes Air flow velocity, ACPH, Filter system integrity, Differential pressure monitoring at rest condition for 1 day, Temperature and RH mapping at rest condition, NVPC, Recovery and viable count monitoring at rest condition only.
PHASE-2: Applicable tests at operation condition shall be carried out in this phase these tests include Viable monitoring at operational condition for 3 days, differential pressure and temperature / RH monitoring at operation condition for 3 day.
NOTE: After successful completion of Phase-1, area shall be released for carrying out Phase-2 activity and final approval shall be done after completion of Phase-2

If any concerns related to validation feel free to reply to [email protected]

Regards
Bhavani
 

With the above attachments which explined by sir and also Go through the ISO14644-1,&14644-3 for frequency of the procedure and for limitations,and frequency for PQ and Rq.

What to perform in HVAC Validation?
Than Answer is your User Requirement Specification, which includes requirement.
For the requirement you can refer WHO guideline : http://www.who.int/medicines/areas/quality_safety/quality_assurance/HVAC_Part2_QAS18-759-15022018.pdf?ua=1
above is under draft, but still you can find the requirement.
Test Methodology, Report and criteria , you can refer ISO 14644

Ideally Protocol should cover below requirement (But not limited to) :

  1. Objective
  2. Scope
  3. Responsibility
  4. Training Participation
  5. Instrument detail to be used for the Validation activity and their status
  6. SOP detail
  7. Acceptance criteria of the test
  8. Methodology/Procedure of the Test
  9. Reporting Result
  10. Non Compliance observed (if any)
  11. Summary and Conclusion
  12. Approval of the protocol

Some industries follow Pre Approval and Post Approval concept. but it may vary

Hi. I wonder whether we should operate all equipment 24/7 during phase-2 or not?

Thank you.


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