Oil-Free Compressed Air System

To describe guideline for the validation of the oil-free compressed air system 

It is the responsibility of the technical service manager to follow the procedure. The quality assurance manager is responsible for SOP compliance. 

Two types of compressed air systems are found in an aseptic manufacturing facility  

The system consists of an oil-free compressor, drier, storage tank, and distribution system. The validation process consists of installation qualification, operational qualifications, and actual validation testing of the operational system. 

Materials Gas bag, 3.8 liter capacity (rubber bladder), with stopcock Rubber tubing of appropriate size Aluminium foil squares (10 x 10 cm) 

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An oil-free compressed air system is normally used in aseptic areas and often may be involved with product contact. 

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