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. No	Name of the area	Area (SQFT)	Height (FT)
1	Sampling	148	9.84
2	Wash	41	9.84
3	Change Room	59	9.84
4	Sampling	149	9.84
5	Air lock	77	9.84
6	Sifting	162	9.84

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 Equipment	Purpose	Calibration Required	Done on	Due on	Calibration Confirmed By
Magnehelic Gauge	For checking the Pressure Drop across the AHU Filters	Yes
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 Equipment	Location	Calibration Done on	Calibration Due on	Calibrated 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 Particulars		Specified Function	Observations		Checked By
1		Primary Checks
1.1		Check for the Supply Blower and Motor of Air Handling Unit
1.1.1		Check 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.
1.1.2		Check the motor shaft rotation, manually.		Motor shaft should rotate smoothly when rotated manually.
1.1.3		Check the Blower rotation, manually.		Blower should rotate smoothly when rotated manually.
1.1.4		Check the motor shaft key and hub screws.		Motor should be tightened with shaft key and hub screws.
1.1.5		Check 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
1.2.1		Open 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.
	1.2.2		Open 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 Particulars		Specified Function	Observations	Checked By
2  Operational Checks
2.1  Check for the Power supply
2.1.1	Switch on the main power supply to the control panel Located at Ground Floor.	Power supply indicator should glow in the control panel
2.1.2	Switch on the control panel power supply to the Air Handling Unit	Air Handling Unit blower motor should start.
2.2 Check for the Supply Air Blower
2.2.1	Check the supply air blower for any abnormal sound	There should not be any abnormal sound in the supply air blower.
2.2.2	Check 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
2.3.1	Check the differential pressure of the 10+5 m filters	Differential pressure of the filters should be between   4-12mm of wc
2.3.2	Check the differential pressure of the 3 m filters	Differential 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.

Checks	Observations	Checked by
Whether the acceptance criteria of the protocol and specific checkpoints are met.

SUMMARY AND CONCLUSION

Appendix

6.1          ABBREVIATIONS:-

 

Sr. No.	Term	Explanation
1	AHU	Air Handling Unit
2	DQ	Design Qualification.
3	IQ	Installation Qualification
4	OQ	Operational Qualification
5	GI	Galvanized Iron
6	SS	Stainless Steel.
7	Temp	Temperature
8	RH	Relative Humidity
9	ACPH	Air Changes per Hour.
10	CFM	Cubic Feet per minute
11	MOC	Material of construction
12	Cont.	Continued
13	WC	Water column
14	SOP	Standard Operating Procedures
15	0C	Degree centigrade
16	m	Micron
17	cGMP	Current Good manufacturing practices
18	Min	Minimum
19	Max	Maximum
20	NMT	Not more than
21	NLT	Not less than
22	NA	Not Applicable
23	EPS	Expanded polystyrene
24	DX	Direct Expansion
25	HEPA	High efficiency particulate air.

ABBREVIATIONS (CONTD.):-

Sr. No.	Term	Explanation
26	FPI	Fins per Inch.
27	ADP	Apparatus dew point
28	ISO	International Organization for Standardization.
29	URS	User requirement specification
30	Q. A. Head	Quality Assurance Head
31	VCD	Volume Control Damper.
32	GSS	Galvanized sheet steel
33	AL.	Aluminium
34	NR	Not Required
35	DIDW	Double Inlet Double Width
36	DB	Dry Bulb
37	FLP	Flame Proof
38	KW	Kilo Watt
39	HP	Horse Power
40	Ph	Phase
41	Sq. Cg.	Squirrel Cage
42	Pa	Pascal

CERTIFICATION FOR OPERATIONAL QUALIFICATION

 

The system is now ready FOR PERFORMANCE QUALIFICATION