A Seminar on VALIDATION OF COMPRESSED AIR

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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

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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 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

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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 compressors 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

• 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

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• 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)

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• 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

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• All in-line filters are integrity tested and
  qualify per manufacturers operating
  specifications
• Dew point must be lt0 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

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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 -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

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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 50F (-1.67
  to 10C) pressure dew point, removes 70 of oil

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Contd

• Function

• Level of Application

• Removes 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

• 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)

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Contd

• Level of Application

• Function

• Breathing Air
• (continuous or portable)

• 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-quali
  ty.html
• http//validationworld.com

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• THANK YOU