Medical Devices

Compressed Air and Medical Device Manufacturing

TRI Air Testing provides independent laboratory support for many medical device companies. We offer 24-hour turnaround time and online laboratory reports via MYAIR.

TRI Air Testing offers medical gas testing with our air test kit for pipes.

It’s critical to know the proper compressed air quality level for medical gas purity testing when considering FDA enforced cGMP.

In the absence of specified standards governing compressed air quality testing in the medical device manufacturing process, it is often best to use  site-specific air testing programs for Points of Use (POU). This may be the most assured way to produce valid, repeatable testing results that will reinforce your site’s quality.

TRI recommends Direct Product Contact, Indirect Product Contact, United States Pharmacopeia (USP), the European Pharmacopeia, or the ISO 8573 air standard for Points of Use (POU).

We can also test nitrogen, oxygen, argon, carbon dioxide, custom compressed air specifications and more.  The air used in the manufacturing processes should be evaluated by a competent technical individual to determine the appropriate requirements to protect the safety of the employees and the integrity of the products.

A thorough evaluation of the application and manufacturing process is required to ensure the appropriate solution, both technically and financially.  TRI recommends a compressed air baseline test before validation to determine SOPs.  TRI also has experienced validation and qualification Dealers that can visit with your company.  They can work with your requirements and staff to produce the validatable systems, descriptions and documents you need to move your project forward.

The quality of the independent laboratory you use is critical to ensuring that your facility’s efforts to achieve compressed air best practices  are optimized. Understanding your true medical gas testing needs and utilizing high-quality laboratory support are keys to air quality compliance.

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* If your specification requires a breakdown of oil mist from particulate a 48 hour turnaround is required to meet this specification.