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PERFORMANCE QUALIFICATOIN PROTOCOL PROTOCOL No.:

FOR
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COMPRESSED AIR GENERATION AND DISTRIBUTION SYSTEM
PAGE No.: 1 of 20

PERFORMANCE QUALIFICATION
PROTOCOL
FOR
COMPRESSED AIR GENERATION AND
DISTRIBUTION SYSTEM

EQUIPMENT ID. No.

LOCATION Utility Block

DATE OF QUALIFICATION

SUPERSEDES PROTOCOL No. NIL

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PAGE No.: 2 of 20

CONTENTS

S.No. TITLE PAGE No.

1.0 Protocol Approval 3

2.0 Objective 4

3.0 Scope 4

4.0 Responsibility 5

5.0 Equipment Details 6

6.0 System Description 6

7.0 Site of Study 8

8.0 Frequency of Qualification 8

9.0 Pre-Qualification Requirements 8

10.0 Tests & Checks 9

11.0 References 13

12.0 Documents to be Attached 14

13.0 Non Compliance 14

14.0 Deviation From Pre–Defined Specification, If Any 14

15.0 Change Control, If Any 14

16.0 Abbreviations 15

17.0 Annexure-I List of critical and non-critical user points 16

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1.0 PROTOCOL APPROVAL:
INITIATED BY:

DESIGNATION NAME SIGNATURE DATE

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(PRODUCTION)
HEAD
(QUALITY CONTROL)
HEAD
(ENGINEERING)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)
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PAGE No.: 4 of 20
2.0 OBJECTIVE:
 To provide documented evidence that the Compressed Air System is performing consistently,
repeatedly and reproducibly within its established operating range and the results of all the test
parameters meet the pre-defined acceptance criteria.
 To confirm the suitability of the Standard Operating Procedures for all routine activities associated
with the system.

3.0 SCOPE:
 The Protocol covers all aspects of Performance Qualification for the Compressed Air System
(Make- Chicago Pneumatics) installed in the Utility Block at …………..
 This Protocol will define the methods and documentation used to qualify the Compressed Air
System for PQ.
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4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following departments, shall be
responsible for the overall compliance of this Protocol cum Report:

DEPARTMENTS RESPONSIBILITIES

 Preparation, Authorization, Approval and Compilation of the Performance

Qualification.
Quality Assurance  Co-ordination with Quality Control, Production and Engineering to
carryout Performance Qualification Activity.
 Monitoring of Performance Qualification.
 Review of Protocol.
Production
 To co-ordinate and support Performance Qualification Activity.
 Review of Protocol.
Quality Control
 Analytical Support (Microbiological Testing/Analysis)
 Reviewing of qualification protocol for correctness, completeness and
technical excellence
Engineering
 Responsible for trouble shooting (if occurred during execution).
 Maintenance & preventive maintenance as per schedule.
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PERFORMANCE QUALIFICATOIN PROTOCOL PROTOCOL No.:

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5.0 EQUIPMENT DETAILS:
Equipment Name Compressed Air System
Equipment
Manufacturer’s Name Chicago Pneumatics
Model GMP Model
Supplier’s Name Chicago Pneumatics
Location of Installation Utility Block

6.0 SYSTEM DESCRIPTION:

Air compressor unit has an air unit system which is responsible for delivering quality compressed air at
the outlet. It starts from the suction filter of the compressor and ends at the final service valve of the
unit. Air compressor provides a filter of superior grade at the suction of the compressor to avoid any
ingress of solid particles. The compressor cylinder, during suction stroke, aspires atmospheric air
through the filer and compresses it to the delivery pressure.

The delivery pressure is achieved by compressing the air in stages. Between successive stages a highly
efficient heat exchanger is provided to remove the heat of compression. Air, before passing to the next
stage is cooled to near about atmospheric temperature in the heat exchanger. This helps in reducing the
final air discharge temperature as well as the power consumption of the compressor.

Sterilizing grade 0.2 micron hydrophobic filter shall be fixed at critical user points to deliver sterilized
compressed air supply, wherever required and filters with sufficient particulate and microbial retention
efficiency may also be installed at the user points to improve the purity of supplied air. The oil-free
compressed air system consists of an oil-free compressor, storage tank and refrigerant dryer and
distribution system.

Air compressor is double acting horizontal cross head type, it consists two cylinders each cylinder is
fitted with suction and delivery valves. The suction air filter is connected at the middle of cylinders, so
that air can enter, at both ends of the piston during the forward and backward strokes. Quantity of air
sucked at the front side is compressed up to approx 2 Kg/cm2 pressure.
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After compression, the air from the first stage cylinder, passes through the delivery valves to the inter
cooler provided between the first and second stage. There it is cooled approx 30  50C temperature and
is sucked by the 2nd stage through the suction valves. In the next stage the compressed air up to the 8.0 
0.5 Kg/cm2 pressure enters to the delivery header connected to the cooler and finally to the receiver.

PRESSURE
VESSEL-02
AIR SUCTION
PUMP
PRESSURE
VESSEL-03
SAFETY GUARD FOR
INDUCTION MOTOR

RADIATOR
ASSEMBLY

INDUCTION MOTOR

COMPRESSOR
PISTON
ASSEMBLY

Fig. 01: Key Components of Compressed Air System

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COOLANT
SUPPLY DUCT

CONTROL
PANEL

PRESSURE RADIATOR
VESSEL-04 ASSEMBLY

PRESSURE
VESSEL-01

Fig. 02: Key Components of Compressed Air System

RADIATOR FAN
ASSEMBLY

CONTROL
PANEL

COOLANT
SUPPLY DUCT
COOLANT
FLOW LIMIT
SWITCH

COOLANT
SUPPLY
MOTOR

Fig. 03: Key Components of Compressed Air System

 PHARMA DEVILS
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PERFORMANCE QUALIFICATOIN PROTOCOL PROTOCOL No.:

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PAGE No.: 9 of 20
7.0 SITE OF STUDY:
Utility Block

8.0 FREQUENCY OF QUALIFICATION:

 Once in every two years time period.
 After any major breakdown or after major modification.
 After Change of Location.

9.0 PRE – QUALIFICATION REQUIREMENTS:

The below mentioned activities should be completed prior to commencing the performance qualification
activity:
 Completion of design qualification activity
 Completion of installation qualification activity
 Completion of operational qualification activity
 Preparation of SOP for Operating & Cleaning of Compressed Air System.

10.0 TESTS AND CHECKS:

A. Document Verification.
B. Verification of Calibration of test instruments.
C. Performance Qualification Testing:
Performance Qualification study shall be carried out using following tests:
 Determination of Oil Content in Compressed Air
 Determination of Moisture Content in Compressed Air
 Viable Particle Count
 System Supply Reliability Test
List critical and non-critical user point all mentioned in the annexure-I of this protocol. Testing for
performance qualification activity shall be performed on the critical & non-critical compressed air
supply points which are in use as applicable and all new introduced supply points shall be enclosed as
addendum to the PQ report.
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PAGE No.: 10 of 20
Acceptance Criteria:
 DQ, IQ & OQ activity should be completed and executed, approved qualification report should be
available prior to commencing the performance qualification activity.
 Calibration of all components of system should be completed prior to commencing the
performance qualification activity.
 Compressed air should meet the specifications for oil content, water content, viable particle count
and system supply reliability test.
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PAGE No.: 11 of 20
10.1 Determination of Oil Content in Compressed Air:
Objective:
The objective of this test is to ensure that, the compressed air that is used for various processes is free
from oil contaminants or such contaminants is removed up to acceptable level from compressed air
during air drying and filtration stage.

Principle:
The test is performed to determine the oil content in the compressed air. Test is carried out using the
Gastec tubes (Oil Mist Airtec Tubes No. 109AD).

Specifications for Oil Mist (Mineral Oils) Airtec Tubes No. 109AD are as follows:
S. No. Parameter Specification
1. Measuring Range 0.2 to 5.0 mg/m3
2. Sampling Volume 20000 ml
3. Sampling Rate 1 Liter per minute
4. Sampling Time 20 minutes
5. Colour Change Pale Red Pale Blue
6. Reaction Principle Oil Mist + Cr6+ (Pale Red Color) Cr3+ (Pale Blue Color)

Measuring Procedure:
1. Attach a pressure reducer with gauze and flow meter to a cylinder, compressor or compressed air
line and adjust the pressure between 2.0 – 2.5 kg/cm2 for supply of compressed air to the flow meter
assembly.
2. Adjust the flow rate by setting knob of flow meter assembly to set the flow rate of 1000 ml per
minute.
3. Stop supply of compressed air to the test unit.
4. Break tips of Gastec tube using tube tip breaker.
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5. Attach the Gastec Tube to the assembly keeping the arrow showing the flow direction of air towards
the flow meter side (Side A shown in the picture).
6. Start supply of compressed air to the test assembly.
7. If required adjust the flow rate by setting knob of flow meter.
8. Record the time.
9. On completion of 20 minutes stop supply of compressed air to test assembly.
10. Record the reading for oil content shown on the scale by pale blue color.
11. Detach Gastec tube from the test assembly.

Acceptance Criteria:
Oil Content should be below 1 mg/m3.

Frequency:
Initially from Critical User Points.

10.2 Determination of Water Vapor Content in Compressed Air:

Objective:
The objective of this test is to ensure that, the compressed air that is used for various processes is free
from water vapor or water vapor is removed up to acceptable level from compressed air during air
drying and filtration stage.
Principle:
The test is performed to determine the moisture content in the compressed air. Test is carried out using
the Gastec tubes (Water Vapour Airtec Tubes No. 6Ag).

Specifications for Water Vapour Airtec Tubes No. 6Ag are as follows:
S. No. Parameter Specification
1. Measuring Range 150 to 3000 mg/m3
2. Sampling Volume 300 ml
3. Sampling Rate 300 ml per minute
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4. Sampling Time 1 minutes

5. Colour Change Green Purple
6. Reaction Principle H2O + Mg(ClO4)2 (Green Color) Mg(ClO4)2 (Purple Color)

Measuring Procedure:
1. Attach a pressure reducer with gauze and flow meter to a cylinder, compressor or compressed air
line and adjust the pressure between 2.0 – 2.5 kg/cm2 for supply of compressed air to the flow meter
assembly.
2. Adjust the flow rate by setting knob of flow meter assembly to set the flow rate of 300 ml per
minute.
3. Stop supply of compressed air to the test unit.
4. Break tips of Gastec tube using tube tip breaker.
5. Attach the Gastec Tube to the assembly keeping the arrow showing the flow direction of air towards
the flow meter side (Side A shown in the picture).
6. Start supply of compressed air to the test assembly.
7. If required adjust the flow rate by setting knob of flow meter.
8. Record the time.
9. On completion of 1 minute stop supply of compressed air to test assembly.
10. Record the reading for moisture content shown on the scale by purple color.
11. Detach Gastec tube from the test assembly.

Acceptance Criteria:
Water Vapor Content should be below 500 mg/m3.

Frequency:
Initially from Critical User Points.

10.3 Viable Particle Count:

Objective:
Objective of this test is to ensure that, the Viable Particle Count of compressed air that is used in various
user points is within the permissible limit of Not More Than 100 CFU/1000 ml of air.
Methodology:
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 Connect compressed air test assembly to the compressed air supply point.
 Adjust knob of assembly to set pressure of 2.0 kg/cm2.
 Adjust knob of flow regulator to set flow rate of 500 ml per minute.
 Stop supply of compressed air to the unit.
 Remove cotton plug of flask containing nutrient media and immerge tube of assembly in the media.
 Start supply of compressed air to the unit to start purging of compressed air in the nutrient media.
 Perform purging of compressed air through nutrient media for 2 minutes.
 On completion of purging time stop supply of compressed air and close the flask containing nutrient
media with cotton plug and seal by wrapping with aluminum foil.

Acceptance Criteria:
Less than 100 cfu / 1000 ml of air.

Frequency:
5 times from each Critical User Points on different days.

10.4 System Supply Reliability Test:

Objective:
The objective of this test is to ensure that, the pressure of compressed air at individual user point is
available as per the specified limit mentioned in the design specification.

Methodology:
Determine the compressed air pressure at individual user points.

Acceptance Criteria:
0.2 to 6.5 kg/cm2

Frequency:
5 times from all User Points on different days.
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PAGE No.: 15 of 20
11.0 REFERENCES:
The Principle Reference is the following:
 Validation Master Plan.
 Schedule-M – “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment
for Pharmaceutical Products.”
 WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol-2 – Good Manufacturing
Practices and Inspection.

The following references are used for addition guidance

 FDA/ISPE Baseline Pharmaceutical Engineering Guide-Volume 5:- Commissioning and
Qualification Guide, First Edition/March 2001.
 EU Guide to Good Manufacturing Practice, Part 4, 1997.
 European Commission’s working party on control of medicines and inspections document,
Validation Master Plan, Design Qualification, Installation & Operational Qualification, Non Sterile
Process Validation, Cleaning Validation, October 1999.

12.0 DOCUMENTS TO BE ATTACHED:

 Operation And Maintenance Manual
 Copy of Draft SOPs
 Any Other Relevant Documents

13.0 NON – COMPLIANCE:

All the Non-compliances of procedure, specifications, and sampling, analysis and documentation
activities shall be monitored & recorded.

14.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY:

 In case of any deviation observed during PQ, inform to Head QA for necessary action.
 Document the deviation detail in observed deviation section.
 The Head QA will study the impact of deviation. If deviation is acceptable and it does not have an
Impact on operation as well as on performance of the machine & prepare final conclusion.
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15.0 CHANGE CONTROL, IF ANY:

 If any change control is required during PQ, inform to Head QA for necessary action.
 Document the details observed.
 The Head QA will study the impact of change. If change is acceptable and it does not have an
Impact on operation as well as on performance of the machine & prepare final conclusion.

16.0 ABBREVIATIONS:
Sr. : Senior
Asst. : Assistant
No. : Number
WHO : World Health Organization
FDA : Food and Drug Administration
CFR : Code of Federal Regulations
cGMP : Current Good Manufacturing Practices
QA : Quality Assurance
CFU : Colony Forming Unit
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ANNEXURE-I
LIST OF CRITICAL AND NON-CRITICAL USER POINTS
Sampling
S.No. Area / Location ID. No. Critical / Non Critical
Points
Granulation 01
Paste room 01 Non-critical

1. FBD 01 Non-critical
FBD 01 Non-critical
RMG 01 Critical
Granulation 02
Paste room 01 Non-critical
2.
FBD 01 Non-critical
RMG 01 Critical
3. Granulation 03
Paste room 01 Non-critical
FBD 01 Non-critical
RMG 01 Critical
4. Granulation 05
Paste room 01 Non-critical
FBD 01 Non-critical
RMG 01 Critical
5. Granulation 06
Paste room 01 Non-critical
FBD 01 Non-critical
FBD 01 Non-critical
RMG 01 Critical
Octagonal Blender 01 Non-critical
6. Granulation 07
Paste room 01 Non-critical
FBD 01 Non-critical
FBD 01 Non-critical
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Sampling
S.No. Area / Location ID. No. Critical / Non Critical
Points
RMG 01 Critical
Octagonal Blender 01 Non-critical
7. Granulation 10
FBD 01 Non-critical
8. Compression-01 01 Non-critical
9. Compression-02 01 Non-critical
10. Compression-03 01 Non-critical
11. Compression-04 01 Non-critical
12. Compression-05 01 Non-critical
13. Compression-06 01 Non-critical
14. Compression-07 01 Non-critical
15. Compression-08 01 Non-critical
16. Compression-09 01 Non-critical
17. Compression-10 01 Non-critical
18. Compression-11 01 Non-critical
19. Compression-12 01 Non-critical
20. Compression-13 01 Non-critical
21. Compression-14 01 Non-critical
22. Compression 15 01 Non-critical
23. Compression 16 01 Non-critical
24. Compression 17 01 Non-critical
25. Compression 18 01 Non-critical
26. Coating 01 01 Critical
27. Coating 02 01 Critical
28. Coating 03 01 Critical
29. Coating 04 01 Critical
30. Coating 05 01 Critical
31. Coating 06 01 Critical
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Sampling
S.No. Area / Location ID. No. Critical / Non Critical
Points
32. Coating 07 01 Critical
33. Coating 08 01 Critical
34. Coating 09 01 Critical
35. Coating 10 01 Critical
36. Coating 11 01 Critical
37. Coating 12 01 Critical
38. Coating 13 01 Critical
39. Capsule filling 01 01 Critical
40. Capsule filling 02 01 Critical
41. Capsule filling 03 01 Critical
42. Soft Gel Section 01 Critical
43. Soft Gel Section 01 Critical
44. Soft Gel Section 01 Critical
45. Soft Gel Section 01 Critical
46. Packing Line 01 (BLM) 01 Critical
47. Packing Line 02 (BLM) 01 Critical
48. Packing Line 03 (ABB) 01 Critical
49. Packing Line 04 (BLM) 01 Critical
50. Packing Line 05 (BLM) 01 Critical
51. Packing Line 06 (ABB) 01 Critical
52. Packing Line 07 (BLM) 01 Critical
53. Packing Line 08 (BLM) 01 Critical
54. Packing Line 09 (ABB) 01 Critical
55. Packing Line 10 (BLM) 01 Critical
56. Packing Line 11 (BLM) 01 Critical
57. Packing Line 12 (STP) 01 Critical
58. Packing Line 13 (BLM) 01 Critical
59. Packing Line 14 (STP) 01 Critical
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Sampling
S.No. Area / Location ID. No. Critical / Non Critical
Points
60. Packing Line 15 (STP) 01 Critical
61. Packing Line 16 (STP) 01 Critical
62. Packing Line 17 (ABB) 01 Critical
63. Packing Line 18 (ABB) 01 Critical
64. Packing Line 19 (STP) 01 Critical
65. Packing Line 20 (STP) 01 Critical
66. Packing Line 21 (BLM) 01 Critical
67. Packing Line 22 (BLM) 01 Critical
68. Packing Line 23 (BLM) 01 Critical
69. Packing Line 24 (FFS) 01 Critical
70. Packing Line 25 (PFM) 01 Critical
71. Packing Line 26 (BLM) 01 Critical
72. Packing Line 27 (BLM) 01 Critical
73. RM Liquid 01 Critical
74. Filter Cleaning 01 Non-critical
75. Softgel section capsule 01 critical
polishing
76. Water System 01 Non-critical
Water System 01 Non-critical

Note:
 Critical Points: Is defined as point where the compressed air being supplied by the point is carried to
direct contact with the product and has impact on the product.
 Non-Critical Points: Is defined as point where the compressed air being supplied by the point does not
come in contact with the product but used in the operating system to run the equipment.
 Identification Tags for compressed air supply points of RMG, FBD & Auto Coater shall be placed on
the compressed air distribution control panel of equipments located at the service floor and sampling
shall be performed from the point installed in the equipment specially where the air is coming in
direct contact with the product.