600.100

TITLE: Oil-Free Compressed Air System

AUTHOR: ________________________________________Name/Title/Department

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CHECKED BY: ________________________________________Name/Title/Department

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APPROVED BY: ________________________________________Name/Title/Department

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REVISIONS:

YOUR COMPANYVALIDATION 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. Thequality 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-lubricatedcompressors and is used for operating instruments and machinery whereno contact with the product or product environment exists.

An oil-free compressed air system is normally used in aseptic areas andoften 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 stopcockRubber tubing of appropriate sizeAluminium foil squares (10 10 cm)

Sampling: Use method as recommended by the manufacturer with all safetyprecautions.

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 noadditional peaks other than those obtained with the air standard.

Frequency

Initial validation: once at all critical supply pointsRevalidation: 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 thesystem from a different location each day. The test program should cover all criticalsupply 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

SOP No. Val. 600.100 Effective date: mm/dd/yyyy

Approved by:Initial validation: one test per day for the first 30 days of the operation of thesystem from all critical supply point locations each day.

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 volumeflow of about 30 l/min. The particle counter is connected to the outlet; at themaintained flow a minimum volume of 90 liters is monitored. Each supply pointshould 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 abovetests.

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