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INSTALLATION QUALIFICATION PROTOCOL AIR COMPRESSOR

PROTOCOL APPROVAL

THE IQ PROTOCOL FOR AIR COMPRESSOR, HAS BEEN REVIEWED AND APPROVED FOR IMPLEMENTATION BY AUTHORISED PERSONNEL FROM THE FOLLOWING DEPARTMENTS

Prepared by:

NAME SIGNATURE DATE

Approved by:

FUNCTION NAME SIGNATURE DATE
VALIDATION
PRODUCTION
SERVICES
QUALITY ASSURANCE

 

CONTENTS

INSTALLATION QUALIFICATION PAGE
1.    OBJECTIVE / PURPOSE
2.    EQUIPMENT DESCRITION, 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

MODEL : CTA-158

SERIAL  No.:: 14001

TYPE : RECIPROCATING,2 STAGE,NON LUBRICATE

CAPACITY : 500 CFM

EQUIPMENT CODE :

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 with respect to 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

 

Description Specified Actual Checked By
Motor
Make

 

Crompton Greaves
Sr. No.
KW/HP 75/100
RPM 1480
Pulley size 12”
Full load Amps. 123 A
Insulation Class F

 

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
  • Name of the component: Compressor  
Description Specified Actual Checked By
Make Ingersoll-rand
CFM 500
Location Utility block
CYLINDER (LOW  PRESSURE)
TYPE NON LUBRICATED
CAPACITY 1.8 KG /SQ CM
CYLINDER (HIGH PRESSURE)
TYPE NON LUBRICATED
CAPACITY 7.5 KG /SQ CM
FLY WHEEL SIZE 28”

 

Installation Consideration
Status

(Yes/No)

Checked By

 

Properly mounted, supported & connected
Properly labeled / Identified

( To be verified with PI- diagram)

 

Documentation
Attached

(Yes/No)

Checked By

 

Component Data / P.O Specifications for basic unit
Test Certificates

 Name of the component: Inter cooler & after cooler Section 

Description Specified Actual Checked By
Inter cooler Section
Make Ingersoll-rand
Capacity Shell-8.08 kg/sq cm

tube-4.21 kg/sq cm

Code no A-129/aeh-99056/36
Type Shell &air tube

 

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

Name of the component: Inter cooler & after cooler Section 

Description Specified Actual Checked By
After cooler Section
Make AERO-ENGINEERS
Capacity Shell-6 kg/sq cm tube-12 kg/sq cm
Code no RIN 7699T6
Serial no AE:6073
Type Shell &air tube

 

Installation Consideration
Status

(Yes/No)

Checked By

 

Properly mounted, supported & connected
Properly labeled  / Identified

( To be verified with PI- diagram)

 

Documentation
Attached

(Yes/No)

Checked By

 

Component Data / P.O Specifications for basic unit
Test Certificates

Name of the component: Air receiver tank 

Description

Specified

Actual Checked By
Make Premier engg.equip.
Type Vertical position.
MOC M .S
Total Nos. 1
Dimensions 30×93.5×6/8 mm
Working Pressure 150 PSIG
Capacity 1 cubic meter

 

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

Name of the component: Air dryer Section

Description Specified Actual Checked By
Make Sanpar
type Mechanical refrigeration
Capacity Dew point 2 –4 °c
Full load Amps 123 amps

 

Installation Consideration
Status

(Yes/No)

Checked By

 

Properly mounted, supported & connected
Properly labeled / Identified

( To be verified with PI- diagram)

 

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

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

Description Specified Actual Checked By
i) Supply Pipes
 MOC G.I
CLASS “C”
SIZE As per design specification
ii) Valves
MOC Cast iron
TYPE Ball valves
MAKE Aduco
iii) Supply Air Filters
MAKE Sanpar
MOC Sintered bronze
SIZE 5 micron
LOCATION Before air dryer
iv) Supply Air Filters
MOC Sintered bronze
MAKE Sanpar
SIZE 0.1 micron
LOCATION After air dryer.

 

Installation Consideration
Status

(Yes/No)

Checked By

 

Properly mounted, supported & connected
Properly labeled / Identified

( To be verified with PI- diagram)

 

Documentation
Attached

(Yes/No)

Checked By

 

Component Data / P.O Specifications for basic unit
Test Certificates

Name of the component: Filters

Description Specified Actual Checked By
i) Suction side filter
Make Ingersoll-rand.
Capacity 20 micron
Type Dry type  – 2 stage
MOC Paper-element
ii) Suction side filter
Make Ingersoll-rand.
Capacity 20 micron
Type Dry type  – 2 stage
MOC Paper-element

 

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

Name of the component: Electrical controls Section

Description Specified Actual Checked By
Make Allenbradely
Flame proofing Not applicable
Signal Indicators RYB
Full load Amps 123 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,

Description Specified Actual Checked By
Indicator for Main On Three R Y B Indicators
Auto /Manual selector switch To operate in Auto or Manual

SAFETY QUALIFICATION 

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

UTILITIES AND SERVICES REQUIRED 

 

Sr .No REQUIREMENTS SUPPLIERS SPECIFICATION VERIFICATION
1.  Electrical network

 

415 V/50 cs/3 Phase

AC supply through suitable isolator

2.  Electrical backup system Optional
3.  Lighting Not Specified
4. Cooling water  for inter Cooler , after cooler and

Cylinder jackets

From cooling tower.
5.  Lubrication To crank shaft, case, and internal moving parts.
6.  Log  Sheets Optional

LIST OF SPARE PARTS: 

S.No. Description of Spares Quantity
1. Air filter 1z
2. Piston rings 2
3. Wearing 1
4. Loading valve 1
5. Discharge valve 1
6. Servo 220 oil 100Ltrs
7. Auxiliary valve 1
1. Scrapper rings 1 set

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

INSTALLATION VERIFICATION:

 Installation Verification Check List 

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

Description Of Non- Conformance of related parts 

S. No. Specifications       Actual Probable reasons Checked by
1.
2.
3.
4.

Correction of Non Conformance

S. No. Correction  Done Done by Checked  by
1.  

 

2.  

 

3.  

 

4.  

 

 

9.2 Compliance Report

S. No. Description of conformance Checked by        Remarks
1.  

 

2.  

 

3.  

 

4.  

 

 

10.0 INSTALLATION QUALIFICATION 

10.1 Discussions:

10.2 Recommendations:

Team:

Department Name Signature Date
Validation
Production
Services
Quality Assurance

 

 

   

 

 

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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