ASeminar on

VALIDATION OF COMPRESSED AIR

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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Typical Compressed Air System Layout :

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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 13

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)14

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 16

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 classesPart 2 - Test methods for aerosol oil contentPart 3 - Test methods for the measurement of humidityPart 4 - Test methods for solid particle contentPart 5 - Determination of oil vapor and organic solvent

contentPart 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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Final Report

• Depending on IQ , OQ and PQ data final report is made and

that will indicate whether your system is validated or not

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Applications :

Level of application• Shop air

(Filtered centrifugal separator)

• Air Tools, Sand Blasting, Pneumatic Control Systems

(Dryer and Air line filter)

Function• Removes solids 3 microns

& larger, 99% of water droplets, & 40% of oil aerosol

• Removes moisture producing a 35° to 50°F (-1.67° to 10°C) pressure dew point, removes 70% of oil

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Contd…Level of Application

• Instrument Air, Paint Spraying, Powder Coating, Packing Machines

(Dryer, Oil remover filter)

• Indoor Applications, Food Industry, Dairy Industry, Laboratories

(Dryer , Filter and Oil vapour absorber)

Function• Removes moisture &

produces a 35° to 50°F (-1.67° to 10°C) pressure dew point, removes 99.999% of oil aerosols, and all particles .025 microns and larger

• Removes moisture & produces a 35° to 50°F (-1.67° to 10°C) pressure dew point, removes 99.999% of oil aerosols, all particles .025 microns and larger, oily vapor, oily smell, & oily taste

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Contd…

Level of Application

• Breathing Air (continuous or

portable)

Function

• Removes harmful compressed air contaminants and will produce Grade D breathing air

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How to get efficiency and power savings?

• Establish regular maintenance programme

• Hunt for air leaks

• Educate your plant staff and emphasizing the importance of monitoring the line

• Check system operating pressure

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References

Agalloco James, Carleton J. Fredric “Validation of Pharmaceutical Processes”; Third edition

Syed Imitiaz Haider, Pharmaceutical Master Validation Plan, The ultimate guide to FDA , GMP and GLP compliance

Syed Imtiaz Haider, “Validation Standard Operating Procedure”,2nd Edition

www.usvalidation.com http://www.validationwhat.com/compressed-air-quality.html http://validationworld.com

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THANK YOU

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