Professional Documents
Culture Documents
OF
COMPRESSED AIR
❖ Validation protocol :
❖ Applications
❖ References
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Introduction
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Compressed air is an important component of pharmaceutical
manufacturing facilities
The application for which the compressed air will be used will dictate
the level of air quality that is appropriate for use
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Direct Impact Systems :
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
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
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How the Compressed Air System(CAS) works?
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Components of the CAS system
Inlet filter:
Compressor :
Compressor Controller :
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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
9
• Dryer :
• 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 :
Pressure Regulator :
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Test Functions :
1. Perform Installation Qualification
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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
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Acceptance Criteria :
16
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 :
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Installation Qualification (IQ)
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Contd…
Materials of construction will vary with gas type, and must agree
with specification
Verify that the systems have been thoroughly cleaned and dried
before operation
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Operational Qualification
21
Contd…
All use points supply the specified pressure prior to any pressure
reducing valves or equipment
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Performance Qualification
23
Contd…
• The highest total particulate count from the five one-minute runs
must meet class 100 or EC Class A criteria
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Contd…
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