600.

100
TITLE: Oil-Free Compressed Air System
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REVISIONS:
YOUR COMPANY
VALIDATION STANDARD OPERATING PROCEDURE
SOP No. Val. 600.100 Effective date: mm/dd/yyyy
Approved by:
No. Section Pages Initials/Date
2002 by CRC Press LLC
SUBJECT: Oil-Free Compressed Air System
PURPOSE
To describe guideline for the validation of the oil-free compressed air system
RESPONSIBILITY
It is the responsibility of the technical service manager to follow the procedure. The
quality assurance manager is responsible for SOP compliance.
PROCEDURE
1. Types of Compressed Air Systems
Two types of compressed air systems are found in an aseptic manufacturing facility:
An instrument air system normally consists of conventional oil-lubricated
compressors and is used for operating instruments and machinery where
no contact with the product or product environment exists.
An oil-free compressed air system is normally used in aseptic areas and
often may be involved with product contact.
The system consists of an oil-free compressor, drier, storage tank, and distri-
bution system. The validation process consists of installation qualification, opera-
tional qualifications, and actual validation testing of the operational system.
2. Installation Qualification of Oil-Free Compressor
Verify and document specifications on purchase order against actual deliv-
ery.
Check and document that no oil or other lubricant is used in the compres-
sor.
Verify and document that all required utilities are connected properly.
Verify prestartup procedures.
Document calibration performed.
SOP No. Val. 600.100 Effective date: mm/dd/yyyy
Approved by:
2002 by CRC Press LLC
3. Installation Qualification of Compressed Air Storage Tank
Check and document that the materials of construction are as specified.
Check storage tank for adequate capacity.
Perform and document pressure hold test to determine that the leak rate
is within specification.
Perform and document the cleaning procedures after installation.
Check and document all pressure ratings.
Calibrate all critical pressure gauges and control sensors on the storage tank.
4. Installation Qualification Distribution System
Check and document that the materials of construction are as specified.
Follow the drawings of the system to trace the actual constructed system
and make an as built drawing.
Pressure test the system and document.
Clean the system with detergent or solvent and document the procedures.
Label all piping and components.
5. Operational qualification
5.1 Chemical investigation
Sampling procedure
Materials: Gas bag, 3.8 liter capacity (rubber bladder), with stopcock
Rubber tubing of appropriate size
Aluminium foil squares (10 10 cm)
Sampling: Use method as recommended by the manufacturer with all safety
precautions.
6. Identification
Procedure
Use gas chromatograph for the identification of compressed air. For comparison,
an air standard should be used.
SOP No. Val. 600.100 Effective date: mm/dd/yyyy
Approved by:
2002 by CRC Press LLC
Requirements
The identity test for oil-free compressed air must show a chromatogram with no
additional peaks other than those obtained with the air standard.
Frequency
Initial validation: once at all critical supply points
Revalidation: once at all critical supply points
7. Moisture Content
Procedure
Use dew-point meter to determine moisture content from critical supply point
Requirements
Moisture content measurements at supply point should not be greater than in-
house specification
Frequency
Initial validation: one test per day for the first 30 days of the operation of the
system from a different location each day. The test program should cover all critical
supply points.
Revalidation: one test from each critical supply point per month.
8. Oil Content
Procedure
Use oil indicators.
Requirements
Oil content of oil-free compressed air should be not more than 0.01 ppm.
Frequency
Initial validation: one test per day for the first 30 days of the operation of the
system from all critical supply point locations each day.
SOP No. Val. 600.100 Effective date: mm/dd/yyyy
Approved by:
2002 by CRC Press LLC
Revalidation: one test from each critical supply point
9. Nonviable Particle Count
Procedure
The outlet of the supply point is opened and purged for 5 min. Adjust to a volume
flow of about 30 l/min. The particle counter is connected to the outlet; at the
maintained flow a minimum volume of 90 liters is monitored. Each supply point
should be investigated in the same way.
Requirements
No requirements; for information only
Frequency
Initial validation: once for each supply point.
Revalidation: every 3 months
9.1 System supply reliability test
Document the system pressure twice a day over a period of about 30 working days.
The data generated should be compared with the specifications of the system.
10. Certification
The system can be certified after successful execution and documentation of above
tests.
REASONS FOR REVISION
Effective date: mm/dd/yyyy
First time issued for your company, affiliates, and contract manufacturers
SOP No. Val. 600.100 Effective date: mm/dd/yyyy
Approved by:
2002 by CRC Press LLC