INSTALLATION QUALIFICATION PROTOCOL AIR COMPRESSOR

INSTALLATION QUALIFICATION PROTOCOL AIR COMPRESSOR

PROTOCOL APPROVAL

THE IQ PROTOCOL FOR AIR COMPRESSORS, HAS BEEN REVIEWED AND APPROVED FOR IMPLEMENTATION BY AUTHORISED PERSONNEL FROM THE FOLLOWING DEPARTMENTSPrepared by:

CONTENTS

INSTALLATION QUALIFICATION
1.    OBJECTIVE / PURPOSE
2.    EQUIPMENT DESCRIPTION, IDENTIFICATION, AND CHECKS
3.    MAJOR COMPONENTS
4.    EQUIPMENT CONTROL SYSTEM
5.    SAFETY QUALIFICATION
6.    UTILITIES AND SERVICES REQUIRED
7.    LIST OF SPARE PARTS
8.    INSTALLATION VERIFICATION
9.    DESCRIPTION OF NON CONFORMANCE
10.  INSTALLATION QUALIFICATIONS – DISCUSSIONS   AND RECOMMENDATIONS

TYPE: RECIPROCATING,2 STAGE,NON LUBRICATE, CAPACITY: 500 CFM

LOCATION  : FORMULATIONS UNIT, SERVICE BLOCK

OBJECTIVE / PURPOSE

INSTALLATION QUALIFICATION:

To establish documented evidence that the AIR COMPRESSOR  is installed as per the Design specifications, Manufacturer’s recommendations and Process requirements, complies with standard operating procedures and cGMP requirements at Pharmaceutical company.

ACCEPTANCE OF INSTALLATION INCLUDES,

  • Installation of the equipment with suitable utility connections.
  • Equipment meets the current Good Manufacturing Practice (cGMP) requirements.
  • Installation of the equipment compliance with Design specifications and safety considerations.
  • Installation of Auxiliary equipment with suitable Utility connections.

EQUIPMENT DESCRIPTION AND IDENTIFICATION:

DESCRIPTION – ASSEMBLY:

Air compressor with LP& HP Cylinders: It is responsible for handling the air concerning the receival of fresh air (after filtration), compression of first stage in LP cylinder and second stage compression in HP cylinder, cooling and distribution to the respective areas.

Air compressor Inter Cooler Section: The air is passed through intercooler section where air temperature will be reduced & moisture shall condensate .

Air compressor After Cooler Section: The air passed through a aftercooler section where air  temperature will be reduced & moisture will be  condensates.

Air compressor Receiver tank: It provides momentary reserve capacity, to improve regulation and to ensure a smooth flow through out the system.

Air Dryer: It removes the moisture content (water vapor) present in the air prior sending to respective areas.

Air compressor Electrical Section: The total Air compressor system is operated from electrical control panel.

Air Distribution piping, valves and filters: This is involved in the distribution of the processed filtered air to the specified areas. It also provide a mechanism of controlling the air volume as per the requirement of the areas during the normal run.

MAJOR COMPONENTS

Sr. No.Description
1.Air compressor with LP& HP cylinders
2.Inter cooler, section
3.After cooler section
4.Receiver tank
5.Electrical control section
6.Air dryer
7.Air distribution – piping, valves, and filters

MAJOR COMPONENTS

Name of the component:  Compressor with LP& HP cylinders 

DescriptionSpecified
Motor
MakeCrompton Greaves
Sr. No.
KW/HP75/100
RPM1480
Pulley size12”
Full load Amps.123 A
Insulation ClassF

 

Installation Consideration
Status (Yes/No)
Properly mounted, supported & connected
Properly labeled / Identified

( To be verified with PI- diagram)

 

Documentation
Attached (Yes/No)
Component Data / P.O Specifications for basic unit
Test Certificates

Name of the component: Compressor  

DescriptionSpecifiedActual
MakeIngersoll-rand
CFM500
LocationUtility block
CYLINDER (LOW  PRESSURE)
TYPENON LUBRICATED
CAPACITY1.8 KG /SQ CM
CYLINDER (HIGH PRESSURE)
TYPENON LUBRICATED
CAPACITY7.5 KG /SQ CM
FLY WHEEL SIZE28”

 

Installation Consideration
Status (Yes/No)
Properly mounted, supported & connected
Properly labeled / Identified

( To be verified with PI- diagram)

 

Documentation
Attached (Yes/No)
Component Data / P.O Specifications for basic unit
Test Certificates

 Name of the component: Inter cooler & after cooler Section 

DescriptionSpecified
Inter cooler Section
MakeIngersoll-rand
CapacityShell-8.08 kg/sq cm

tube-4.21 kg/sq cm

Code noA-129/aeh-99056/36
TypeShell &air tube

 

Installation Consideration
Status (Yes/No)
Properly mounted, supported & connected
Properly labeled / Identified ( To be verified with PI- diagram)

 

Documentation
Attached (Yes/No)
Component Data / P.O Specifications for basic unit
Test Certificates

Name of the component: Inter cooler & after cooler Section 

DescriptionSpecified
After cooler Section
MakeAERO-ENGINEERS
CapacityShell-6 kg/sq cm tube-12 kg/sq cm
Code noRIN 7699T6
Serial noAE:6073
TypeShell &air tube

 

Installation Consideration
Status (Yes/No)
Properly mounted, supported & connected
Properly labeled  / Identified ( To be verified with PI- diagram)

 

Documentation
Attached (Yes/No)
Component Data / P.O Specifications for basic unit
Test Certificates

Name of the component: Air receiver tank 

Description

Specified

Actual
MakePremier engg.equip.
TypeVertical position.
MOCM .S
Total Nos.1
Dimensions30×93.5×6/8 mm
Working Pressure150 PSIG
Capacity1 cubic meter

 

Installation Consideration
Status (Yes/No)
Properly mounted, supported & connected
Properly labeled / Identified ( To be verified with PI- diagram)

 

Documentation
Attached (Yes/No)
Component Data / P.O Specifications for basic unit
Test Certificates

Name of the component: Air dryer Section

DescriptionSpecifiedActual
MakeSanpar
typeMechanical refrigeration
CapacityDew point 2 –4 °c
Full load Amps123 amps

 

Installation Consideration
Status (Yes/No)
Properly mounted, supported & connected
Properly labeled / Identified ( To be verified with PI- diagram)

 

Documentation
Attached (Yes/No)
Component Data / P.O Specifications for basic unit
Test Certificates

Name of the component: Air Distribution – Piping, Valves, & Filters

DescriptionSpecifiedActual
i) Supply Pipes
 MOCG.I
CLASS“C”
SIZEAs per design specification
ii) Valves
MOCCast iron
TYPEBall valves
MAKEAduco
iii) Supply Air Filters
MAKESanpar
MOCSintered bronze
SIZE5 micron
LOCATIONBefore air dryer
iv) Supply Air Filters
MOCSintered bronze
MAKESanpar
SIZE0.1 micron
LOCATIONAfter air dryer.

 

Installation Consideration
Status (Yes/No)
Properly mounted, supported & connected
Properly labeled / Identified( To be verified with PI- diagram)

 

Documentation
Attached (Yes/No)
Component Data / P.O Specifications for basic unit
Test Certificates

Name of the component: Filters

DescriptionSpecifiedChecked By
i) Suction side filter
MakeIngersoll-rand.
Capacity20 micron
TypeDry type  – 2 stage
MOCPaper-element
ii) Suction side filter
MakeIngersoll-rand.
Capacity20 micron
TypeDry type  – 2 stage
MOCPaper-element

 

Installation Consideration
Status (Yes/No)
Properly mounted, supported & connected
Properly labelled  / Identified ( To be verified with PI- diagram)

 

Documentation
Attached (Yes/No)
Component Data / P.O Specifications for basic unit
Test Certificates

Name of the component: Electrical controls Section

DescriptionSpecifiedActual
MakeAllenbradely
Flame proofingNot applicable
Signal IndicatorsRYB
Full load Amps123 amps

 

Installation Consideration
Status (Yes/No)
Checked By
Properly mounted, supported & connected
Properly labelled  / Identified

( To be verified with PI- diagram)

 

Documentation
Attached (Yes/No)
Checked By
Component Data / P.O Specifications for basic unit
Test Certificates

 

4.0 EQUIPMENT CONTROL SYSTEM: 

Equipment shall be controlled by independent electrical panels located near the Air Handling Unit.

Control panel consists of the following,

DescriptionSpecifiedActualChecked By
Indicator for Main OnThree R Y B Indicators
Auto /Manual selector switchTo operate in Auto or Manual

SAFETY QUALIFICATION 

S.NO.     CHECKOBSERVATION CHECKED BY
1.0LOCATION
2.0SAFETY  GUARDS  FOR MOVING  PARTS
3.0SAFETY INTERLOCKS
4.0EARTHING
5.0SERVICES
a.  ELECTRICITY
b. COOLING WATER
6.0NOISE
7.0VIBRATION
8.0LIGHTING
9.0SIGNS
10.0PRESSURE  TESTING
11.0SAFETY  ALARMS
12.0EMERGENCY  STOP  ACCESSIBLE

UTILITIES AND SERVICES REQUIRED 

 

Sr .NoREQUIREMENTSSUPPLIERS SPECIFICATIONVERIFICATION
1. Electrical network

 

415 V/50 cs/3 Phase

AC supply through suitable isolator

2. Electrical backup systemOptional
3. LightingNot Specified
4.Cooling water  for inter Cooler , after cooler and

Cylinder jackets

From cooling tower.
5. LubricationTo crank shaft, case, and internal moving parts.
6. Log  SheetsOptional

LIST OF SPARE PARTS: 

S.No.Description of SparesQuantity
1.Air filter1z
2.Piston rings2
3.Wearing1
4.Loading valve1
5.Discharge valve1
6.Servo 220 oil100Ltrs
7.Auxiliary valve1
1.Scrapper rings1 set

 Refer section supplier’s manual for code number of spares and other spares

INSTALLATION VERIFICATION:

 Installation Verification Check List 

S.No.ConsiderationActualChecked By
1Major components are securely anchored and protected from shock
2There is no observable physical damage
3Sufficient room for servicing provided.
4Electrical connections have been done according to the drawings and grounded.
5Equipment identification nameplate is visible.
6Units installed on foundation and secured in place as per manufacturer’s recommendations.
7The equipment is furnished with proper earthing arrangements.
8Air receiver tank installed with all necessary instruments
9Chilled water supply properly connected
10Safety valve is provided for air receiver

Description Of Non- Conformance of related parts 

S. No. Specifications      ActualProbable reasonsChecked by
1.

Correction of Non-Conformance

S. No. Correction  DoneDone byChecked  by
1.

 9.2 Compliance Report

S. No.Description of conformanceChecked by Remarks
1.

10.0 INSTALLATION QUALIFICATION 

10.1 Discussions:

10.2 Recommendations:

Team:

DepartmentNameSignatureDate
Validation
Production
Services
Quality Assurance

 

 

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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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