VALIDATION

OF

COMPRESSED AIR

Arvind Kumar Srivastava

Asst. Manager QA , Beta Drugs limited , Baddi
Mobile No. 9817039581
Email ID : arvindsri82@gmail.com
 CONTENT
❖ Introduction

❖ How Compressed Air System(CAS) works?

❖ Test functions and Acceptance criteria

❖ Validation protocol :

✓ Installation Qualification (IQ)

✓ Operational Qualification (OQ)

✓ Performance Qualification (PQ)

❖ Applications

❖ How to gain efficiencies and power savings?

❖ References
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 Introduction

What is Compressed Air?

❖ Commonly called Industry's Fourth Utility

❖ Air that is condensed and contained at a pressure that is greater

than the atmosphere

❖ The process takes a given mass of air, which occupies a given

volume of space, and reduces it into a smaller space. In that space,
greater air mass produces greater pressure. The pressure comes
from this air trying to return to its original volume

❖ It is used in many different manufacturing operations. A typical

compressed air system operating at 100 psig (7 bar) will compress
the air down to 1/8 of its original volume. (figure CA1-1)

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 Compressed air is an important component of pharmaceutical
manufacturing facilities

 It provides many of the air types necessary for a manufacturing

facility to function, including: breathing air , motive air for machines
, process air , analytical air and Product Direct Impact , or "cGMP" air

 The application for which the compressed air will be used will dictate
the level of air quality that is appropriate for use

 There are two main categories of applications: Direct Impact

Systems and Indirect Impact System

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Direct Impact Systems :

 The systems will have direct contact with the product

 The system will provide an excipient, or produce an ingredient or

solvent

 The system will be used in cleaning or sterilizing

 The system will preserve product status

 The system will produce data which is used to accept or reject the
product

 The system will be a process control system that can affect product
quality and there will be no system for independent verification of
control system performance
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Indirect Impact or No Impact Systems :

 The system will not contact the product or materials that ultimately
become part of the product

 The systems are generally site or building systems and are not
tailored specifically to aseptic manufacturing facilities

 The systems will deal with a side activity of the manufacturing

process (such as waste disposal)

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How the Compressed Air System(CAS) works?

 Each component in a typical system helps to deliver clean, dry,

compressed air that’s free of pressure fluctuations at its point of
use

 If any component is working inefficiently, the system’s

performance suffers and operating costs rise

 Like any high-pressure system, they are prone to leaks or other

failures that can result in lower performance

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Components of the CAS system

 Inlet filter:

Removes particles from the air entering the compressor

 Compressor :

Compresses air to a small volume, increasing the pressure

(Reciprocating compressors are frequently used)

 Motor : Drives the compressor

 Compressor Controller :

Directs the compressor’s output and it may be microprocessor,

electromechanical or pneumatically based

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 Aftercooler :

Compression leaves the air hot and wet. The aftercooler lowers
the temperature of the air leaving the compressor and removes
water that condenses as the air cools

 Separator : Removes liquids from the compressed air

 Receiver : Stores a large reserve of compressed air to maintain a

smooth flow to the plant

 Air line Filter :

Removes solids and liquids from the compressed air stream. Can
be placed throughout the system

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• Dryer :

❖ Helps to eliminate any remaining moisture in the compressed air by

using either a refrigerated condenser or a desiccant

❖ Refrigerated condensers cool the air to condense water vapours

into a liquid that is then drained from the system. Desiccants are
powders or gels that remove water by absorbing it

• Condensate Trap :

Collects and discharges liquid that condenses out of the air stream
Integral part of aftercoolers, dryers and separators

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 Distribution Piping :

Links the components. It distributes the air from a main header to

branch lines and sub headers to drop points connected to
individual tools

 Pressure Regulator :

Controls air pressure and flow at individual points of use

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Test Functions :
1. Perform Installation Qualification

2. Perform general operational controls verification testing

3. Operate system throughout the range of operating design

specifications or range of intended use

4. Verify that the compressed air system is capable of supplying

pressurized compressed air to all use points. Perform an
operational test of the distribution system and pressure
regulators by monitoring the pressure output at the respective
use points

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5. Perform a capacity test to verify that the system is capable of
supplying the required gas, pressure, and flow rate at each use
point

6. Verify that in-line filters are integrity tested. Confirm that all
documentation clearly indicates acceptable test results

7. Perform dew point measurement

8. Perform hydrocarbon content measurement

9. Perform viable particulate count, microbiological at critical use

points after sterile filters (refer to Federal Standard 209E)
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10. Identification of oxygen content

11. Record the range of all process or equipment parameters (set

points, flow rates, timing sequences, concentrations, etc.)
verified during Operational and Performance Qualifications
testing

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Acceptance Criteria :

1. The system is installed in accordance with design specifications,

manufacturer recommendations and cGMPs. Instruments are
calibrated, identified, and entered into the calibration program

2. General controls, alarms, and interlocks operate in accordance

with design specifications

3. The system operates in accordance with design specifications

throughout the operating range or range of intended use

4. The compressed air distribution system must consistently deliver

pressurized compressed air to the use points at the design
pressure as specified
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5. All in-line filters are integrity tested and qualify per manufacturer’s
operating specifications

6. Dew point must be <0° or lower

7. Hydrocarbon content must be ≤ 1 ppm

8. Viable particulate must be ≤ 1.0 cfu/10 ft3

9. Nonviable particulate counts must be ≤ 100/ft3 of 0.5μ or larger at

all critical use points

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Method for Dew Point and Oil Content

 As per Air Quality Standards ISO 8573 and Filter Standard ISO 12500 for
compressed air there are nine part to it as follows :

❖ Part 1 - Contaminants and Purity classes

❖ Part 2 - Test methods for aerosol oil content

❖ Part 3 - Test methods for the measurement of humidity

❖ Part 4 - Test methods for solid particle content

❖ Part 5 - Determination of oil vapor and organic solvent content

❖ Part 6 - Test methods for gaseous contaminant content

❖ Part 7 - Test method for viable microbiological contaminant content

❖ Part 8 - Test methods for solid particle content by mass concentration

❖ Part 9 - Test methods for liquid water content

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Validation Protocol :
 It includes :
✓ Installation Qualification
✓ Operational Qualification
✓ Performance Qualification
✓ Final Report

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Installation Qualification (IQ)

 This section establishes documented verification that key

aspects of equipment adhere to approve design intentions and
recommendation of manufacturer have been suitably consider

 In addition to the common requirements outlined in the

"General" section, the following are required for Distribution
systems

 The piping should be supported, labeled, and sloped to drain

completely

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Contd…

 Materials of construction will vary with gas type, and must agree
with specification

 Verify that in-line filters can be integrity tested

 Verify that the systems have been thoroughly cleaned and dried
before operation

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Operational Qualification

 This section Establishes that there is a documented verification

that the installed system functions as a specified and that there is
a sufficient documentary evidence to demonstrate this

 The OQ protocol will outline tests to study capacity and pressure

during estimated minimum and maximum use

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Contd…

 All use points supply the specified pressure prior to any pressure
reducing valves or equipment

 All use point supply the volume of gas as specified

 Each peak load use point as specified by use or equipment

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Performance Qualification

 This section gives documented verification that the

equipment performance in its normal operating environment
is consistently exactly as specified in User Requirement
Specification (URS)

 Testing will include viable and total particulate counts, dew

point, hydrocarbon analysis, and purity analysis

 Each point of use will be tested at least three times over 10

working days. Every use point of the system must be tested
several times over the course of the study.

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Contd…

• Hydrocarbon Monitoring should show less than 0.2 mg/m3 (25

mg/125 liters) detected. (the lower limit of a Dragger tube)

• The highest total particulate count from the five one-minute runs
must meet class 100 or EC Class A criteria

• Viable Monitoring (not needed of integrity tested final filter is in

place) less than 0.03 CFU/ft3 or less than 1 CFU/m3

• Since the gas is field sampled under non-sterile conditions, a few

sporadic, individual, tests may fail. Persistent test failures with
any individual test, or group of tests, will indicate a system
failure

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Contd…

 The dew point of compressed air less than or equal to -10°C, or

less than the lowest temperature to which the system is
exposed

 Identity and Purity (Nitrogen) Not less than 99.0% nitrogen by

volume. Not more than 0.001% Carbon Monoxide. No
appreciable odor

 Identity and Purity (Oxygen) Not less than 99.0% Oxygen by

volume. No appreciable odor

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