If your equipment is used in 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 proper performance.  Here’s what we recommend for common oxygen equipment.

Servomex Or Paramagnetic Analyzer

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

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

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.