Oxygen is a critical component of medical care and is often used to treat patients with respiratory illnesses, among other conditions. In order to ensure that the oxygen being supplied is of high quality and meets the necessary standards, it is important for companies in the medical oxygen industry to regularly calibrate their equipment. 

If your equipment is used the "manufacture, processing, packing, and holding of a drug product" it must be routinely calibrated, inspected, or checked according to a written program designed to ensure performance. Here's what we recommend for common oxygen equipment.

Servomex or Paramagnetic Analyzer | Calibrate Daily

Paramagnetic oxygen analyzers are required by the FDA's current good manufacturing practices. Paramagnetic oxygen analyzers are different from handheld analyzers because they are more precise, and the final testing for USP oxygen must be done with a paramagnetic analyzer. Your analyzer should be calibrated every fill day and sent in annually for preventative maintenance.

Gauges and Thermometers | Calibrate Annually

High pressure gauges, vacuum gauges, and thermometers should be calibrated to NIST standards annually. NIST stands for National Institute of Standards and Technology. The FDA specifically references this standard in their Guidance for Industry. 

Pigtails | Inspect Visually Daily, Tested Annually

Pigtails used on your transiflling system, if maintained properly, can last for years. Every time you fill, you should visually inspect your pigtails for damage. If there are kinks or weak points, such as from folding, the pigtails could snap from the high pressure and become dangerous to you or others. Additionally, Applied recommends that pigtails used with transfilling systems be tested annually to ensure they are safe for use. 

Regular equipment calibration is an essential part of ensuring the quality and safety of medical oxygen. To learn more about equipment calibration and how Applied can help, contact us at orders@applied-inc.com or by calling 888-327-7301.