ASeminar onVALIDATION OF COMPRESSED AIR

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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*

IntroductionWhat is compressed air? Commonly called Industry's Fourth UtilityAir that is condensed and contained at a pressure that is greater than the atmosphereThe 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 volumeIt 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 productThe system will provide an excipient, or produce an ingredient or solventThe system will be used in cleaning or sterilizingThe system will preserve product statusThe system will produce data which is used to accept or reject the productThe 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 thats free of pressure fluctuations at its point of use

If any component is working inefficiently, the systems 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*

Typical Compressed Air System Layout :*

Components of the CAS systemInlet 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 compressors output and it may be microprocessor, electromechanical or pneumatically based *

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*

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*

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*

Test Functions :Perform Installation Qualification

Perform general operational controls verification testing

Operate system throughout the range of operating design specifications or range of intended use

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*

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

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

Perform dew point measurement

Perform hydrocarbon content measurement

Perform viable particulate count, microbiological at critical use points after sterile filters (refer to Federal Standard 209E)*

Identification of oxygen content

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 :The system is installed in accordance with design specifications, manufacturer recommendations and cGMPs. Instruments are calibrated, identified, and entered into the calibration program

General controls, alarms, and interlocks operate in accordance with design specifications

The system operates in accordance with design specifications throughout the operating range or range of intended use

The compressed air distribution system must consistently deliver pressurized compressed air to the use points at the design pressure as specified*

All in-line filters are integrity tested and qualify per manufacturers operating specifications

Dew point must be

Method for Dew point and Oil contentAs 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 *

Validation Protocol :It includes :

Installation Qualification Operational Qualification Performance Qualification Final Report*

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*

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 QualificationThis 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 *

ContdAll 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 QualificationThis 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*

Contd

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

Applications :Level of applicationShop air (Filtered centrifugal separator)

Air Tools, Sand Blasting, Pneumatic Control Systems (Dryer and Air line filter)FunctionRemoves solids 3 microns & larger, 99% of water droplets, & 40% of oil aerosol

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

ContdLevel of ApplicationInstrument Air, Paint Spraying, Powder Coating, Packing Machines (Dryer, Oil remover filter)

Indoor Applications, Food Industry, Dairy Industry, Laboratories (Dryer , Filter and Oil vapour absorber)FunctionRemoves moisture & produces a 35 to 50F (-1.67 to 10C) pressure dew point, removes 99.999% of oil aerosols, and all particles .025 microns and larger

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

ContdLevel of Application Breathing Air (continuous or portable)FunctionRemoves harmful compressed air contaminants and will produce Grade D breathing air*

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 editionSyed Imitiaz Haider, Pharmaceutical Master Validation Plan, The ultimate guide to FDA , GMP and GLP complianceSyed Imtiaz Haider, Validation Standard Operating Procedure,2nd Editionwww.usvalidation.comhttp://www.validationwhat.com/compressed-air-quality.htmlhttp://validationworld.com

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THANK YOU*