1. A Seminar on VALIDATION OF COMPRESSED AIR

2. 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

3. 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)

4. 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

5. 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

6. 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)

7. 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

8. Typical Compressed Air System Layout :

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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)

15. 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

16. 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

17. All in-line filters are integrity tested and qualify per manufacturer’s operating specifications
Dew point must be <0° or lower
Hydrocarbon content must be ≤ 1 ppm
Viable particulate must be ≤ 1.0 cfu/10 ft3
Nonviable particulate counts must be ≤ 100/ft3 of 0.5μ or larger at all critical use points

18. Method for Dew point and Oil content
As per Air Quality Standards ISO 8573 and Filter Standard ISO 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

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

20. 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

21. 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

22. 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

23. 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

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, 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.

25. 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

26. 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

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

28. Applications : Level of application Function Shop air
(Filtered centrifugal separator)
Air Tools, Sand Blasting, Pneumatic Control Systems
(Dryer and Air line filter)
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

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

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

31. 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

32. 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

33. THANK YOU