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INSTALLATION QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT

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

 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 Vendor and supplied by Client.

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 (AHU-GF-02) 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.

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. Client, 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. Client.

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 =
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

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 Physical Inspection along with Unit Drawing
Location
Filter Class /
Separation Efficiency
Model / Type
Dimensions (mm)
Number of Filters
Pressure difference measuring
Installation

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 =
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

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 and  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).

IQ SUMMARY AND 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.

 

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

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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