Design Qualification of AHU (DQ)

OBJECTIVE for Design Qualification of AHU:

• To prepare the Design Qualification of AHU on basis of system specification design requirement of area and information given by supplier.
• To ensure that all critical aspects of process/product requirement cGMP and safety have been considered in designing the systems and properly documented.

CONTENTS

Title

Protocol Pre-Approval

Objective

Scope

Responsibility

Project Requirements

Brief System Description

System Specifications

Critical Variables to be Met

AHU Parameters

Utility Requirements/ Location Suitability

Technical Specification/ Key Design Features

Safety

Documents to Be Attached

Review (Inclusive of Follow up action if any)

Any Changes Made Against Formally Agreed Parameters

Recommendation

Abbreviations

Protocol Post Approval

PROTOCOL PRE – APPROVAL:

PROTOCOL PREPARED BY:

Department	Name	Signature	Date
Quality Assurance (Officer/Executive)

PROTOCOL REVIEWED BY:

Department	Name	Signature	Date
Quality Assurance (Executive/Manager)
Engineering (Executive/Manager)

PROTOCOL APPROVED BY:

Department	Name	Signature	Date
Quality Assurance (Head)

SCOPE for Design Qualification of AHU:

• The scope of this qualification document is limited to the Design Qualification for Air Handling Unit.
• The protocol will define the methods and documentation used to qualify the HVAC System for IQ.
• The Drawings and GA Drawings provided by vendor shall be verified during Design Qualification.

RESPONSIBILITY:

Departments	Responsibilities
Quality Assurance	Initiation, Preparation, Review and Approval of the Protocol cum Report.Verify critical Process Parameters, Drawings as per the specifications.Co-Ordination with Production and Engineering to carryout Design Qualification Protocol Cum Report.Review of Design Qualification Protocol cum Report after Execution.
Quality Control	Review of Design Qualification Protocol cum Report.Assist in the Verification of Critical Process Parameters Drawing as Per the Specification.
Engineering	Assist in the preparation of Design Qualification protocol cum report.To co-ordinate and support the qualification activity.To assist in verification of Critical Process Parameters, Drawings, as per Requirement.GA DrawingSpecification of the Subordinate/ bought out Items their make model and Quantity.Details of Utilities.Identification of components for Calibration.Material of Construction of all components.Brief process Description.Safety features and Alarms.Pre Installation Requirements.

PROJECT REQUIREMENTS:

To confirm the safe Delivery of the Equipment/System from the Supplier site. To ensure that no Un-authorized or unrecorded design modification shall take place. If at any point of time any change is desired in the mutually agreed design, change control procedure shall be followed and documented. Air Handling Unit is used for maintaining the area as per cGMP requirement.

BRIEF SYSTEM DESCRIPTION for Design Qualification of AHU:

The purpose of Air Handling Unit is to provide a clean and controlled Environment by two levels filtration followed by HEPA filter is provided for supply air system. The HVAC system for third floor comprises of following units:

• AHU – Air Handling Unit
• Air Distribution System

Parameters	Description
AHU Details	It Comprises of AHU PlenumPanel insulation materialHousingAHU BlowerAHU MotorCHW CoilHW CoilChilled Water Circulation ManifoldHot Water Circulation ManifoldAHU Filters – Fresh air pre filter                      – Pre filter                      – Fine Filter                      – HEPA Filter Electrical Starter Panel
Air Distribution System	It Comprises of Terminal filterReturn Air RiserReturn Air VCDFresh air VCDExhaust air VCDChilled water manifoldHot water manifoldDucting             Supply air ducting             Return air ducting Insulation                 Supply air duct insulation                 Return air duct insulation                 Manifold insulation Supply Air VCDFire DamperTerminal filter boxRoom Magnehelic Gauge Chilled water pressure gauzeHot water pressure gauze Temperature and RH controllerAHU Magnehelic Gauge
Environmental Conditions : Temperature & Relative Humidity	23±2 °C & 50±5 %
Quantity of Air Circulation	Total Air Quantity 1278 CFM Recirculation of Air

SYSTEM SPECIFICATIONS for Design Qualification of AHU:

System specification is a document provided by company to manufacturer for HVAC system as per the system specification, Design Requirement of area and Information given by Supplier.

CRITICAL VARIABLES TO BE MET:

AHU PARAMETERS

CRITICAL VARIABLES	ACCEPTANCE CRITERIA	REFERENCES
Working: Working of Air Handling Unit	Should be free from vibration and no sound / particles is produced by the Air Handling Unit	Design Requirement
Electrical Control Panel: (Switch Panel)	The system should have Electrical Control panel (Switch Panel)	Design Requirement

UTILITY REQUIREMENTS/LOCATION SUITABILITY for Design Qualification of AHU:

CRITICAL VARIABLES	ACCEPTANCE CRITERIA	REFERENCES
Utility connections should be available as per the manufacturer’s Specification
Electrical Supply	3 Phase plus Earthing 4 Wire line up to panel board terminal Voltage: 415±10% V Frequency: 50±3% Hz	Design Requirement
Room Conditions	Should be able to meet required controlled environmental conditions 23±2 °C 50±5 %	Design Requirement
Chilled Water piping/Temperature	50 mm / 7 – 12 °C	Design Requirement
Electrical Motor	2.2 KW / 2 Pole	Design Requirement

TECHNICAL SPECIFICATIONS / KEY DESIGN FEATURES for Design Qualification of AHU:

CRITICAL VARIABLES			ACCEPTANCE CRITERIA				REFERENCES
AHU Plenum:
Make			As per requirement				Design Requirement
Panel Construction			Double Skin type				Design Requirement
Type			Floor Mounted cabinet type				Design Requirement
AHU Dimension (L x W x H) (mm)			4120 X 800 X 800				Design Requirement
Panel External skin			0.8 mm pre Coated GI sheet				Design Requirement
Panel Internal skin			0.8 mm Plain GI sheet				Design Requirement
Thickness of panel			50±2 mm thick				Design Requirement
Profile			Thermal Break				Design Requirement
Unit Color			RAL-7047 (TELE GREY)				Design Requirement
Panel Insulation Material:
Insulation Material			CFC free PUF				Design Requirement
Density			38±2 kg/m3				Design Requirement
AHU Blower:
Make			As per requirement				Design Requirement
CFM			1406				Design Requirement
Fan diameter			RH 31C				Design Requirement
Type			Plug type, Balanced centrifugal Impeller				Design Requirement
RPM			4245				Design Requirement
AHU Motor:
Make			As per requirement				Design Requirement
Capacity			2.2 KW				Design Requirement
Efficiency Class			IE-2				Design Requirement
Type			3 Phase				Design Requirement
RPM			2835				Design Requirement
Pole			02				Design Requirement
AHU Coil
Chilled Water Coil
Quantity			01				Design Requirement
Type			Chilled water coil				Design Requirement
Dehumidified CFM			1263				Design Requirement
No. of Rows of the cooling coil			6 Rows				Design Requirement
Fins Material			Aluminum				Design Requirement
Tube Material			Copper				Design Requirement
Fins per Inch			12 FPI				Design Requirement
Output Data
Coil Area (sq Ft)			2.34				Design Requirement
Fin Height x Fin Length (mm)			508 x 462				Design Requirement
Chilled Water Circulation Manifold
Pressure Gauge
Make			As per requirement				Design Requirement
Type			Stainless steel				Design Requirement
Dial size			100 mm				Design Requirement
Range			0-10 kg/cm2				Design Requirement
Location			Chilled water Pipe inlet & outlet				Design Requirement
Quantity			2				Design Requirement
Temperature Gauge
Make			As per requirement				Design Requirement
Type			Stainless steel				Design Requirement
Dial size			100 mm				Design Requirement
Range			0 – 100 °C				Design Requirement
Location			Chilled water Pipe inlet & outlet				Design Requirement
Quantity			02				Design Requirement
Piping
Make			As per requirement				Design Requirement
MOC			Mild steel				Design Requirement
Size			50 mm				Design Requirement
2 – way control Valve
Make			As per requirement			Design Requirement
Type			2 way Valve			Design Requirement
MOC			Grey Iron			Design Requirement
Quantity			01			Design Requirement
Actuator Model			AME 435			Design Requirement
Movement			Linear			Design Requirement
Size			32 mm			Design Requirement
Air Vent
Make			As per requirement			Design Requirement
Size			15mm			Design Requirement
Quantity			01			Design Requirement
Drain Valve
Make				As per requirement		Design Requirement
Size				15 mm		Design Requirement
Quantity				01 No.		Design Requirement
Insulation MOC				Nitrile Rubber		Design Requirement
Insulation thickness				13 mm		Design Requirement
Hot Water Coil
Quantity				01		Design Requirement
Type				Hot water coil		Design Requirement
Dehumidified CFM				1263		Design Requirement
No. of Rows of the cooling coil				2 Rows		Design Requirement
Fins Material				Aluminum		Design Requirement
Tube Material				Copper		Design Requirement
Fins per Inch				12		Design Requirement
Output Data
Coil Area (sq Ft)				2.34		Design Requirement
Fin Height x Fin Length (mm)				508 x 462		Design Requirement
Coil Face Velocity				500 FPM Approx		Design Requirement
Hot Water Circulation Manifold
Pressure Gauge
Make				As per requirement		Design Requirement
Type				Stainless steel		Design Requirement
Dial size				100 mm		Design Requirement
Range				0-10 kg/cm2		Design Requirement
Location				HW Manifold		Design Requirement
Quantity				02		Design Requirement
Temperature Gauge
Make				As per requirement		Design Requirement
Type				Stainless steel		Design Requirement
Dial size				100 mm		Design Requirement
Range				0 – 100 °C		Design Requirement
Location				Hot water Pipe inlet & outlet		Design Requirement
Quantity				02		Design Requirement
Piping
Make				As per requirement
MOC				Mild steel		Design Requirement
Size				25 mm		Design Requirement
3 – way control Valve
Make				As per requirement		Design Requirement
Type				3 way Valve		Design Requirement
Quantity				1		Design Requirement
MOC				Grey Iron		Design Requirement
Actuator Model				AME 435		Design Requirement
Movement				Linear		Design Requirement
Size				25 mm		Design Requirement
Air Vent
Make				Anergy		Design Requirement
Size				15 mm		Design Requirement
Quantity				01 No.		Design Requirement
Drain valve
Make				As per requirement		Design Requirement
Size				15 mm		Design Requirement
Quantity				01 No.		Design Requirement
Insulation MOC				Nitrile Rubber		Design Requirement
Insulation thickness				13 mm		Design Requirement
MOC				Cast Iron		Design Requirement
AHU Filters
Fresh Air Pre Filter	Make			As per requirement		Design Requirement
	Type			Flange		Design Requirement
	Filtration level			G – 4		Design Requirement
	Efficiency			90% down to 10 micron		Design Requirement
	MOC of frame			Aluminum		Design Requirement
	Filter Media			Non-Woven Synthetic		Design Requirement
	Sealant			Epoxy Resin		Design Requirement
	Air Flow CFM			1000		Design Requirement
	Size (mm) / Quantity			305 x 610 x 50/01 No.		Design Requirement
	Filter Face Area(Ft2)			2		Design Requirement
	Initial Pressure drop at rated capacity (mmwg)			5 mm		Design Requirement
	Final pressure drop at rated capacity (mmwg)			10 mm		Design Requirement
Pre-Filter	Make			As per requirement		Design Requirement
	Type			Flange		Design Requirement
	Filtration level			F – 5		Design Requirement
	Efficiency			99 % down to 5 micron		Design Requirement
	MOC of frame			Aluminum		Design Requirement
	Filter Media			Non-Woven Synthetic		Design Requirement
	Sealant			Epoxy Resin		Design Requirement
	Air Flow CFM			1500		Design Requirement
	Size (mm) / Quantity			460 x 610 x 300 -01 No.		Design Requirement
	Filter Face Area(Ft2)			3		Design Requirement
	Initial Pressure drop at rated capacity (mmwg)			6.5 mm		Design Requirement
	Final pressure drop at rated capacity (mmwg)			20 mm		Design Requirement
Fine Filter	Make			As per requirement		Design Requirement
	Type			Flange		Design Requirement
	Filtration Level			F – 7		Design Requirement
	Efficiency			99 % down to 3 micron		Design Requirement
	MOC of frame			Aluminum		Design Requirement
	Filter media			Non woven Synthetic		Design Requirement
	Sealant			Epoxy Resin		Design Requirement
	Air Flow CFM			1500		Design Requirement
	Size (mm) / Quantity			460 x 610 x 300 -01 No.		Design Requirement
	Filter Face Area(Ft2)			3		Design Requirement
	Initial Pressure drop at rated capacity (mmwg)			8 mm		Design Requirement
	Final pressure drop at rated capacity (mmwg)			25 mm		Design Requirement
HEPA Filter	Make			As per requirement		Design Requirement
	Type			Flange		Design Requirement
	Filtration Level			H – 13		Design Requirement
	Efficiency			99.97% down to 0.3 micron		Design Requirement
	MOC of frame			Aluminum		Design Requirement
	Filter media			Micro Fiber  Glass		Design Requirement
	Sealant			Silicon Gel		Design Requirement
	Air Flow CFM			500		Design Requirement
	Filter Face Area(Ft2)			1		Design Requirement
	Size(mm) / Quantity			305 x 305 x 300/ 01 No.		Design Requirement
	Initial Pressure drop at rated capacity (mmwg)			25 mm		Design Requirement
	Final pressure drop at rated capacity (mmwg)			75 mm		Design Requirement
Supply Terminal (HEPA Filter)	Make			As per requirement		Design Requirement
	Filtration Level			H– 14		Design Requirement
	Type			Box		Design Requirement
	Efficiency			99.95 % down to 0.3 µ		Design Requirement
	Casing MOC			Aluminum Extrusion		Design Requirement
	Filter media			Sub Micronics Glass Fiber		Design Requirement
	Sealant			Silicon Gel		Design Requirement
	Air Flow CFM			500 & 250		Design Requirement
	Size(mm) / Quantity			610 x 610 x 81 / 02 Nos. 305 x 305 x 105 /03 Nos.		Design Requirement
	Filter Face Area(Ft2)			8 & 3		Design Requirement
	Initial Pressure drop at rated capacity (mmwg)			250 Pa		Design Requirement
	Final pressure drop at rated capacity (mmwg)			600 Pa		Design Requirement
Housing
Make		As per requirement			Design Requirement
Type		Bottom loading			Design Requirement
MOC		Aluminum anodized extrusion			Design Requirement
Perforated  Sheet		SS 304 18G			Design Requirement
Quantity		05 Nos.			Design Requirement
Return Air Riser
Make		As per requirement				Design Requirement
MOC		G.I. Powder coated				Design Requirement
Quantity Nos.		200 x 78/02 nos. 450 x 78/01 no.				Design Requirement
Return Air Riser Damper
Make		As per requirement				Design Requirement
Type		Manual operated				Design Requirement
MOC		Aluminum				Design Requirement
Quantity Nos.		03				Design Requirement
Supply Air Ducting
Make		As per requirement				Design Requirement
MOC		GI sheet				Design Requirement
Duct Flange		MS angle black painted with GI nut & bolts				Design Requirement
Sealant for Duct joint		RTV Food Grade Sealant				Design Requirement
Return Air Ducting
Make		As per requirement				Design Requirement
MOC		GI sheet				Design Requirement
Duct Flange		MS angle black painted with GI nut & bolts				Design Requirement
Sealant for Duct joint		RTV Food Grade Sealant				Design Requirement
Supply Air Duct Insulation
Make		As per requirement				Design Requirement
MOC		Cross linked polyethylene (XLPE)				Design Requirement
Insusheild Color		Aluminum foil				Design Requirement
Thickness		19 mm for supply duct				Design Requirement
Fire Performance		Class O (As per BS 476 Part 6 & 7)				Design Requirement
Density		25±3 kg/m3				Design Requirement
Location		Supply duct				Design Requirement
Return Air Duct Insulation
Make		As per requirement				Design Requirement
MOC		Cross linked polyethylene (XLPE)				Design Requirement
Insusheild Color		Aluminum foil				Design Requirement
Thickness		13 mm for supply duct				Design Requirement
Fire Performance		Class O (As per BS 476 Part 6 & 7)				Design Requirement
Density		25±3 kg/m3				Design Requirement
Location		Return duct				Design Requirement
Supply Air Volume Control Damper in AHU
Make		As per requirement				Design Requirement
MOC		Aluminum				Design Requirement
Type		Opposed blade				Design Requirement
Size (mm)		400 x300 mm				Design Requirement
Quantity		01				Design Requirement
Return Air Volume Control Damper in AHU
Make		As per requirement				Design Requirement
MOC		Aluminum				Design Requirement
Type		Opposed blade				Design Requirement
Size (mm)		400 x 250 mm				Design Requirement
Quantity		01				Design Requirement
Fresh Air Volume Control Damper in AHU
Make		As per requirement				Design Requirement
MOC		Aluminum				Design Requirement
Type		Opposed blade				Design Requirement
Size (mm)		560 x 255 mm				Design Requirement
Quantity		01				Design Requirement
Exhaust Air Volume Control Damper in AHU
Make		As per requirement				Design Requirement
MOC		Aluminum				Design Requirement
Type		Opposed blade				Design Requirement
Size (mm)		295 x 315 mm				Design Requirement
Quantity		01				Design Requirement
Fire Damper in AHU
Make		As per requirement					Design Requirement
MOC		GSS – Galvanized steel sheet					Design Requirement
Fire rating		90 Minute					Design Requirement
Type		Fusible Link  type with Limit Switch					Design Requirement
Finish		Natural GSS mill finish					Design Requirement
Operation		Manually					Design Requirement
Size		400 x 250					Design Requirement
Quantity		01 No.					Design Requirement
Electrical Panel
Make		As per requirement				Design Requirement
MCCB Rating		630A				Design Requirement
MCB Rating		16A				Design Requirement
Starter		VFD				Design Requirement
Push Button		ABB				Design Requirement
Indication Light LED		ABB				Design Requirement
VFD Rating		2.2KW				Design Requirement
Power Supply		415V AC, 3 Phase, 50 Hz Supply				Design Requirement
Temperature and RH Transmitter
Make		As per requirement				Design Requirement
Model		RHP3M22				Design Requirement
Display		Digital (LCD Display)				Design Requirement
Quantity (Nos.)		01				Design Requirement
AHU Magnehelic Gauges
Make		As per requirement				Design Requirement
Range		0-60 Pa				Design Requirement
Quantity		02				Design Requirement
Location		Across pre Filter & Across Fine Filter				Design Requirement

SAFETY:

CRITICAL VARIABLES	ACCEPTANCE CRITERIA	REFERENCES
On/Off Switch	Should be provided	Design Requirement
Fire Damper	Should be provided	Design Requirement
Limit switch	Should be provided	Design Requirement

DOCUMENTS TO BE ATTACHED:

• GA Drawing of AHU
• Supply and return diffuser layout with room

CONCLUSION & RECOMMENDATION:

……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

ABBREVIATIONS:

HVAC                        : Heating Ventilation and Air Conditioning System

AHU               : Air Handling Unit

HEPA             : High Efficiency particulate Air Filter

Nos.                 : Numbers

CGMP             : Current Good Manufacturing Practices

GA                  : General Arrangement

Hz                   : Hertz

HP                   : Horse Power

KW                 : Kilo Watt

MOC               : Material of Construction

CFM                : Cubic feet per Minute

WC                  : Water Column

PUF                 : Poly Urethane Foam

GI                    : Galvanized Iron

FAD                : Fresh Air Damper

EAD                : Exhaust Air Damper

CHW               : Chilled Water

HW                 : Hot Water

Sq ft                : Square Feet

SS                    : Stainless Steel

RDH               : Rapid Displacement Heat

RPM                : Revolution per Minute

PCGI               : Powder coated Galvanized Iron

VCD               : Volume control Damper

GSS                 : Galvanized Steel Sheet

PROTOCOL POST APPROVAL for Design Qualification of AHU:

This is certified that Air Handling Unit is designed as per GMP requirement and the AHU designed fulfill the GMP Requirements.

APPROVED BY:

DEPARTMENT	NAME	SIGNATURE	DATE
Quality Assurance (Asst. Manager)
Engineering (Head)
Quality Assurance (Head)