VALIDATION OF HVAC SYSTEM
INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM
TABLE OF CONTENTS
| Sr. No | Description | Page No. |
| 1 | Objective | |
| 2 | System / Equipment Description | |
| 3 | Responsibility | |
| 4 | Execution Team | |
| 5 | Installation Verification | |
| 6 | Installation Check | |
| 7 | Documentation Requirement | |
| 8 | Deviation Report | |
| 9 | Installation Qualification Summary & Conclusion | |
| 10 | Abbreviations | |
| 11 | Certification for Installation Qualification |
1. OBJECTIVE
The objective of this protocol is to provide an outline for the inspection of static attributes, written procedure and / or guidelines and respective acceptance criteria for the Installation & Operational Qualification of Air handling unit manufactured by Citizen Industries Ltd. and supplied by __________________.
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 |
| 7 | PM Sampling | 81 | 9.84 |
Installation Qualification
- Each installed components and sub component complies with the engineering design and manufacture recommendations.
- To ensure that appropriate interconnections are made for utilities / equipment that all the features are defined before the start up of operational qualification.
- The system meets the current good manufacturing practice requirements.
- To prepare tentative standard operating procedures.
- Calibration of instruments
- Functional keys.
- Design parameters
- Alarms & interlock systems
- Verification of standard operating procedures.
- Sequential operation
- Effect of power failure on the equipment
SYSTEM / EQUIPMENT DESCRIPTION
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
- RH — NMT 60 %
Description:
Air handling unit is a recirculation system, in double skin modular construction. AHU will have extruded aluminium frame with sandwiched panel of G.I. sheet duly pre coated from outside & 43 mm thick PUF filled in between.
Fresh air enters through 10µ fresh air filter. Air then passes through mixing section with (10 +5) µ pre filter, 6 rows deep CHW coil & 2 rows deep HW coil is placed on condensate tray, Sandwiched type in SS-304 construction with proper drain point. The air will then pass through 3µ fine filter installed in AHU supply plenum.
FA damper are provide with 10µ G-4 pre filter, EA damper are provide with (0.3µ)H-13 HEPA filter.
Filtered air after 3µ filter will be supplied to the room via leak proof GSS Ducting through ceiling mounted Supply air Hepa (0.3 µ) H-13 and air will return through return air Riser via return duct to mixing chamber.
Both ends of the GI ducts will have flanges & flanges will have neoprene gasket. GI ducts will be thermally insulated by Polyethylene foam insulation. Air volume control dampers shall be installed at (fresh, return) air inlet, (supply, bleed) air outlet of AHU and Supply air Hepa & Risers. Fire damper should be installed on supply & return air duct near to AHU.
RESPONSIBILITY
Engineering and Maintenance Department
- Preparation of the IQ protocol in conjunction with user and R&D if required.
- Checking the protocol for adequacy and accuracy prior to the approval.
- Collection of data and preparation of final design.
- Execution of the protocol and preparation of IQ summary report.
User / R & D department
- Providing required details to the Engineering / Maintenance.
- Checking the protocol for adequacy and accuracy.
Head Operations
- Providing guidance and check the protocol document.
Quality Assurance Department
- Providing guidance, wherever required to the related departments.
- Approval of protocol.
EXECUTION TEAM
| Department | Responsibility | Name | Designation | Signature / Date |
| Quality Assurance | Monitoring and reviewing the validation activities | |||
| Engineering | Execute the validation activity and provide necessary support for the proper installation of the equipment | |||
| Production | Participate and provide necessary support for the validation activity |
INSTALLATION VERIFICATION
It was checked and proved that the Air Handling unit and the documentation correspond to the order. In addition, changes and supplements were identified and documented. This review is the basis for further functional reviews, maintenance and modification control.
The IQ protocol defines test procedures, acceptance criteria and the documents that are necessary to prove that the Air Handling unit was installed correctly and corresponds to the specifications of the manufacturers as well as client and that it is suitable for the planned application. The completely executed and finally approved protocol confirms that the Air Handling system is corresponds to all acceptance criteria.
The Installation-Qualification is valid as documented evidence, that the Air Handling Unit corresponds with all checkpoints of design plans, all components of manufacturer’s documentation, rules of technique and the defined requests of M/s. ____________________, The basis for the installation qualification was the detailed design, room tables and the technical Manufacturers documentation.
The following appendices, in the qualification protocol attached, were used for execution of the installation qualification to prove the Air Handling Unit corresponds with the defined requests of M/s. _____________.
The following drawings were compared on site to the existing installation:
- Floor Plan Drawing
- Room Data Sheet
Design Verification
The following components were checked if they are according to the design specification:
- Fresh air filter (G-4)
- Pre Filter (G-4 +F-5 ) Combo
- Fine Filter (F-7)
- Bleed Air Filter (H-13)
- Supply Blower – Motor
- Cooling coil
- Heating Coil
- Supply/Return Air dampers
- Fire Dampers
- Duct work
INSTALLATION CHECK
The listed drawings shall be compared on site to the existing installed and any discrepancy shall be marked by redlining in the drawing. After the completion of the walk down, the checked drawings have to be signed with date and signature and have to be attached to these protocols.
- General Verification:-
| Title | Acceptance criteria | Acceptance criteria fulfilled YES / NO |
| Layout | The drawing reflects “as built” conditions | |
| Room Data Sheet | The drawing reflects “as built” conditions | |
| Grills Location Drawing | The drawing reflects “as built” conditions |
Component: Fresh air Pre Filter
| Feature | Specification = AcceptanceCriteria |
Acceptance
criteria fulfilled |
How verified |
| Manufacturer | Air Tech. | Physical Inspection along with Unit Drawing | |
| Location | AHU | ||
| Filter Class / Efficiency |
10 µ | ||
| Model / Type | Flange type | ||
| Dimensions of Filters(mm) | 305 x 305 x 50 mm | ||
| Number of Filters | 1 Nos | ||
| Installation | Installed in Fresh air Module |
Component: Pre Filter (Combo)
| Feature | Specification | Acceptance criteria fulfilled YES / NO |
How verified |
| Manufacturer | Air tech. | Physical Inspection along with Unit Drawing | |
| Location | Coil protection in mixing chamber | ||
| Filter Class / Separation Efficiency |
10 µ +5 µ | ||
| Model / Type | Flange type Filter | ||
| Dimensions (mm) | 610 x 610 x 380
305 x 610 x 380 |
||
| Number of Filters | 1 Nos Each | ||
| Pressure difference measuring | 4-5 mm | ||
| Installation | Installed in Return Plenum at clean condition |
Component: Fine Filter
| Feature | Specification | Acceptance criteria fulfilled YES / NO |
How verified |
| Manufacturer | Air tech. | Physical Inspection along with Unit Drawing | |
| Location | Supply Chamber in AHU | ||
| Filter Class / Separation Efficiency |
3 µ | ||
| Model / Type | Flange type Filter | ||
| Dimensions (mm) | 610 x 610 x 305
305 x 610 x 305 |
||
| Number of Filters | 1 Nos Each | ||
| Pressure difference measuring | 7.5-8.5 mm | ||
| Installation | Installed in Supply Plenum at clean condition |
Component: Bleed air Filter
| Feature | Specification | Acceptance criteria fulfilled YES / NO |
How verified |
| Manufacturer | Air Tech. | Physical Inspection along with Unit Drawing | |
| Location | AHU | ||
| Filter Class / Efficiency |
0.3 µ | ||
| Model / Type | Flange type | ||
| Dimensions of Filters(mm) | 305 x 305 x 305 mm | ||
| Number of Filters | 1 Nos | ||
| Installation | Installed in Exhaust air Module |
Component: HEPA Filter
| Feature | Specification | Acceptance criteria fulfilled YES / NO |
How verified |
| Manufacturer | NA | Physical Inspection along with Unit Drawing | |
| Location | NA | ||
| Filter Class / Separation Efficiency |
NA | ||
| Model / Type | NA | ||
| Dimensions (mm) | NA | ||
| Number of Filters | NA | ||
| Pressure difference measuring | NA | ||
| Installation | NA |
Component: Fan – Motor
| Feature | Specification | Acceptance criteria fulfilled YES / NO |
How verified |
| Make | Punker | ||
| Type | PLUG Type (non spark proof) | ||
| Capacity | 2718 cfm | ||
| Total Static Pressure | 115 mm of wc | ||
| Fan/ Blower speed(RPM) | 2754 | ||
| Motor | |||
| Make | CG / BBL / ABB / Siemens or equivalent make | ||
| Type | TEFC 3Ph / 4Pole | ||
| Rating | 3.7 kw,2 Pole EFF-2 | ||
Component: Damper
| Feature | Specification = AcceptanceCriteria |
Acceptance criteria fulfilled YES / NO |
How verified |
| Location | Supply, Return, Fresh & Bleed air damper | Visual Inspection | |
| Model / Type | Opposed blade low leakage GI damper | ||
Component: Ductwork
| Feature | Specification = Acceptance criteria |
Acceptance criteria fulfilled YES / NO |
How verified |
| Material | GI sheets | Ducting Layout & Visual Inspection | |
| Manufacturer of Sheets | Jindal / Tata | ||
| Zinc Coating Thickness | Coating of 120g/Sqmtr | ||
| Duct joints | All joints are with angle iron flanges and neoprene rubber gaskets. | ||
| Type of sealing at joints | Silicon sealant at all the longitudinal & transverse joints. | ||
| Sheet thickness | 20/22/24 SWG | ||
| Installation | Completed under clean condition |
Component: Outlet Terminal Box
| Feature | Specification = Acceptance criteria |
Acceptance criteria fulfilled YES / NO |
How verified |
| Manufacturer | MKP | Ducting Layout & Visual Inspection | |
| Type | Swirl Diffuser | ||
| Installation | Completed |
DOCUMENTATION REQUIREMENT
The purpose of documentation is to provide basis for further validation (OQ) and generated documented evidence that the equipment / system was manufactured as per the desired design criteria.
General : Purchase order
: System specification
Instrumentation calibration : Calibration certificate for the Magnehelic Gauge
Other certificates : Certification Manifold valves, Ducting, & Insulation
Lists : Equipment and instrument list with Component descriptions.
: Electrical component parts list with descriptions. Spare parts list.
DEVIATION REPORT
All discrepancies between specification and Acceptance criteria fulfilled yes / no on site concerning the installation equipment, piping, supply and supervision facilities which are discovered during the Acceptance criteria fulfilled yes / no of this protocol have to be documented in this divergence report.
This page may be copied (as often as you need it in case of more than one discovered divergence).
Deviation No.: ______________________
IQ SUMMARY AND CONCLUSION:
SUMMARY
CONCLUSION
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. |
| 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 INSTALLATION QUALIFICATION
This Installation qualification document is studied and approved by the Undersigned Authorized Personnel.
This approved Installation Qualification supersedes all the previously submitted documents and shall form the basis for installation of complete system and validation trials.
