Gerbig Engineering Company Cleanroom Solutions

Regular Testing Strongly Recommended for Compressed Air and Gas Used for Direct Contact with Medical Devices.

Compressed AirThe FDA expects medical device manufacturers to demonstrate that compressed air and gases do not contaminate their products. Gerbig can provide test solutions that meet this expectation. We recommend testing for quality on a regular basis, at a minimum annually, and that the following guidelines inform the acceptance criteria:

Particulate Levels. The number of particles sized 0.5 microns and larger must not exceed the room ISO 14644-1 classification limit. This is most often ISO class 7 but may be more or less stringent.
Particle Levels Chart
Moisture Levels.The amount of moisture should be minimized to prevent microbial growth in piping. Consideration should be given to the lowest ambient temperature the piping passes through to avoid condensation in the piping. A moisture level of 0°F (-20°C) should be adequate.
Oil Levels. No detectable oil should be present. Using detector tubes, the lower limit for detection is 0.4 ppm. Typical spec is 1 ppm or less.
Microbial Levels. Similar to environmental monitoring, microbial samples should be taken to verify that excessive microbial activity is not present. Limits would typically be taken from manufacturing cleanroom specs and range from 3 to 30 CFU/ft (100-1000 CFU/M3). Total count aerobic is most often tested.

ISO 8573 Is the Main Existing Standard for Defining Compressed Air Quality.

The classes in ISO 8573 do not line up precisely with the above recommendations.

ISO 8573 classes are reprinted in abbreviated form here for information. Classes are specified as solids, water, oil. For example, (3, 3, 3) would mean solid particles, 10,000 at 0.5-1 micron; Water, dew point -20C; Oil, 1 mg/m3 (which is close to 1 ppm).

For medical device product contact air, a specification of 3, 3, 3 should be adequate. This can only be achieved with a desiccant dried air system.
Air Quality Chart

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