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A Seminar 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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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 4 . process air . analytical air and Product Direct Impact .• 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 .

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 5 .Direct Impact Systems : • The systems will have direct contact with the product • The system will provide an excipient.

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) 6 .

How the Compressed Air System(CAS) works? • Each component in a typical system helps to deliver clean. they are prone to leaks or other failures that can result in lower performance 7 . compressed air that’s free of pressure fluctuations at its point of use • If any component is working inefficiently. dry. the system’s performance suffers and operating costs rise • Like any high-pressure system.

Typical Compressed Air System Layout : 8 .

9 electromechanical or pneumatically based . increasing the pressure (Reciprocating compressors are frequently used) • Motor : Drives the compressor • Compressor Controller : Directs the compressor’s output and it may be microprocessor.Components of the CAS system • Inlet filter: Removes particles from the air entering the compressor • Compressor : Compresses air to a small volume.

• 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 10 .

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.Integral part of aftercoolers.• Dryer : . dryers and separators 11 .Collects and discharges liquid that condenses out of the air stream . Desiccants are powders or gels that remove water by absorbing it • Condensate Trap : .

• 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 12 .

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 13 respective use points . Perform general operational controls verification testing 3. Perform Installation Qualification 2.Test Functions : 1.

microbiological at critical use points after sterile filters (refer to Federal Standard 209E) 14 . Verify that in-line filters are integrity tested. pressure. Perform dew point measurement Perform hydrocarbon content measurement Perform viable particulate count. 9.5. 8. Perform a capacity test to verify that the system is capable of supplying the required gas. and flow rate at each use point 6. Confirm that all documentation clearly indicates acceptable test results 7.

etc.10. Record the range of all process or equipment parameters (set points.) verified during Operational and Performance Qualifications testing 15 . Identification of oxygen content 11. concentrations. timing sequences. flow rates.

identified. The compressed air distribution system must consistently deliver pressurized compressed air to the use points at the design pressure as specified 16 . General controls. manufacturer recommendations and cGMPs. Instruments are calibrated. alarms.Acceptance Criteria : 1. The system is installed in accordance with design specifications. The system operates in accordance with design specifications throughout the operating range or range of intended use 4. and interlocks operate in accordance with design specifications 3. and entered into the calibration program 2.

Dew point must be <0° or lower 7.5μ or larger at all critical use points 17 . Hydrocarbon content must be ≤ 1 ppm 8. Viable particulate must be ≤ 1.5. Nonviable particulate counts must be ≤ 100/ft3 of 0.0 cfu/10 ft3 9. All in-line filters are integrity tested and qualify per manufacturer’s operating specifications 6.

Test methods for solid particle content by mass concentration Part 9 .Contaminants and Purity classes Part 2 .Test methods for liquid water content 18 .Test methods for the measurement of humidity Part 4 .Test methods for gaseous contaminant content Part 7 .Determination of oil vapor and organic solvent content Part 6 .Test methods for aerosol oil content Part 3 .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 .Test method for viable microbiological contaminant content Part 8 .Test methods for solid particle content Part 5 .

Validation Protocol : • It includes :     Installation Qualification Operational Qualification Performance Qualification Final Report 19 .

labeled. and sloped to drain completely 20 . the following are required for Distribution systems • The piping should be supported.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.

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 21 .

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 22 .

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 23 .

dew point. and purity analysis • Each point of use will be tested at least three times over 10 working days. hydrocarbon analysis. Every use point of the system must be tested several times over the course of the study. 24 .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.

Contd… • Hydrocarbon Monitoring should show less than 0. tests may fail. or group of tests.03 CFU/ft3 or less than 1 CFU/m3 • Since the gas is field sampled under non-sterile conditions. a few sporadic.2 mg/m3 (25 mg/125 liters) detected. Persistent test failures with any individual test. individual. will indicate a system failure 25 . (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.

0% Oxygen by volume.0% nitrogen by volume.001% Carbon Monoxide. Not more than 0. No appreciable odor • Identity and Purity (Oxygen) Not less than 99. No appreciable odor 26 . or less than the lowest temperature to which the system is exposed • Identity and Purity (Nitrogen) Not less than 99.Contd… • The dew point of compressed air less than or equal to -10°C.

OQ and PQ data final report is made and that will indicate whether your system is validated or not 27 .Final Report • Depending on IQ .

Sand Blasting.67° to 10°C) pressure dew point. Pneumatic Control Systems (Dryer and Air line filter) 28 .Applications : Level of application • Shop air (Filtered centrifugal separator) Function • Removes solids 3 microns & larger. 99% of water droplets. removes 70% of oil • Air Tools. & 40% of oil aerosol • Removes moisture producing a 35° to 50°F (1.

and all particles . removes 99. Laboratories (Dryer . Food Industry.999% of oil aerosols.025 microns and larger. all particles . Dairy Industry. Paint Spraying.025 microns and larger • Removes moisture & produces a 35° to 50°F (1. oily vapor. Packing Machines (Dryer.67° to 10°C) pressure dew point.Contd… Level of Application • Instrument Air. & oily taste 29 . Powder Coating.67° to 10°C) pressure dew point. removes 99. oily smell.999% of oil aerosols. Oil remover filter) • Indoor Applications. Filter and Oil vapour absorber) Function • Removes moisture & produces a 35° to 50°F (1.

Contd… Level of Application • Breathing Air (continuous or portable) Function • Removes harmful compressed air contaminants and will produce Grade D breathing air 30 .

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 31 .

GMP and GLP compliance  Syed Imtiaz Haider. Third edition  Syed Imitiaz Haider. Carleton J.html  http://validationworld.References  Agalloco James.com  http://www.com 32 .validationwhat.2nd Edition  www. The ultimate guide to FDA . Fredric “Validation of Pharmaceutical Processes”. “Validation Standard Operating Procedure”. Pharmaceutical Master Validation Plan.usvalidation.com/compressed-air-quality.

THANK YOU 33 .