Installation qualification protocol for air handling unit & air distribution system

Installation qualification protocol for air handling unit & air distribution system

  • OBJECTIVE
  • The objective of this protocol is to provide an outline for the inspection of static attributes, written procedure and  guidelines and respective acceptance criteria for the Installation and Operational Qualification of Air handling unit .
  • The Air-Handling unit caters to:-
AREA DETAILS
Sr. No Name of the area Area (SQFT) Height (FT)

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 –        __________ 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 chilled water coil (CH W) coil & 2 rows deep Hot water (H W) 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 .
  • Checking the protocol for adequacy and accuracy prior to the approval.
  • Providing guidance, wherever required to the related departments.
  • Quality Assurance Department
  • Providing guidance and check the protocol document.
  • Head Operations
  • Checking the protocol for adequacy and accuracy.
  • Providing required details to the Engineering / Maintenance.
  • Collection of data and preparation of final design.
  • Execution of the protocol and preparation of IQ summary report.
  • User  department
  • Approval of protocol.
  • 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
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
  • 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
  • The following components were checked if they are according to the design specification:
  • Design Verification
  • Room Data Sheet
  • Floor Plan Drawing
  • 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, 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.
  • The following drawings were compared on site to the existing installation:
  • 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
  • Remarks____________________________________________
  • Component: Fresh air Pre Filter
Feature Specification = Acceptance Criteria Acceptance

criteria fulfilled
YES / NO

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
  • Remarks__________________________________________________
  • 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
  • Remarks____________________________________________
  • 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
  • Remarks__________________________________________________
  • 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
  • Remarks______________________________________________
  • 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
  • Remarks_______________________________________________
  • 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
  • Remarks__________________________________________
  • Component: Damper
Feature Specification =
Acceptance
Criteria
Acceptance
criteria fulfilled
YES / NO
How verified
Location Supply, Return, Fresh & Bleed air damper Visual Inspection
Model / Type Opposed blade low leakage GI damper
  • Remarks_________________________________________
  • 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
  •  Remarks__________________________________________
  • 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
  • Remarks_____________________________________
  • 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.: ______________________
Deviation
Observed by:                                                                                       Date:
Assessment and Action
Conducted by:                                                                                      Date:
Action taken
Executed by:                                                                                          Date:
Verified by:                                                                                             Date:
  • IQ SUMMARY AND CONCLUSION:
  • SUMMARY —————————————————-
  • CONCLUSION————————————————————————–
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, User Departments
  • History
    Date Revision Number Reason for Revision
    00 New

 

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