Verifying medical oxygen purity for USP compliance

Gas transferred from liquid or large cylinders into smaller ‘homecare’-sized ones must be at least 99% oxygen by volume. Undertaking this operation may lead the company to be viewed as a pharmaceutical manufacturer, meaning it must verify this to meet FDA requirements.

Image Credit: Jamesboy Nuchaikong/Shutterstock.com

 

Application details

As many as 50 or more homecare cylinders are generally filled simultaneously from one header, meaning a single bottle must be tested to verify compliance for the whole batch.

This bottle is removed from the filling rig before being connected to a system that reduces the pressure of the gas enough for it to enter the analyzer. The operator acquires the reading, records it, and confirms that the batch meets the required specification.

Market drivers

Oxygen measurements must be accurate and carried out safely. Servomex offers operator training courses comprised of a study pack and an exam that is completed and returned for marking. The operator is issued with an annual competency certificate if this exam is passed.

The current good manufacturing practice (GMP) guidelines advise that training and retraining are regularly carried out and documented. The Servomex operator training course meets this requirement.

Servomex can also offer equipment rental programs, ensuring that critical instruments are continually available.

Calibration recommendations

The FDA mandates an accuracy of ± 0.1% oxygen from the method being used to determine oxygen content.

Day-to-day barometric pressure variations can change this reading by more than ± 0.1% at high oxygen concentrations, meaning that the SERVOFLEX MiniMP 5200 analyzer should be calibrated daily in line with its operating instructions.

The analyzer must be recalibrated to ensure it remains within the required accuracy limits if it is moved or the ambient temperature changes by more than ∼3 ˚C.

Verifying medical oxygen purity for USP compliance

Image Credit: Servomex

ORSAT and the USP

The wet chemical ORSAT method was previously specified in the United States Pharmacopoeia (USP) for the verification of oxygen. This method was changed to specify superior paramagnetic technology in the early 2010s, however. The ORSAT method should, therefore, no longer be used.

An independent tester noted that the MiniMP 5200 series unit from Servomex offered a range of advantages over the ORSAT method, including:

  • Rapid setup
  • Straightforward calibration
  • Instrument durability
  • Instrument portability
  • Minimal skill and training requirements
  • Objective readings

The unit also offers a range of application-specific features, including

  • Password-protected calibration tracking ensures compliance with FDA inspectors.
  • Concentration alarms streamline vital pass/fail decisions.
  • QuickConnect fittings reduce leaks and accelerate daily calibration.
  • RS-232 output allows connection to PC systems.
  • Vehicle power or rechargeable batteries can optionally be used.

Acknowledgments

Produced from materials originally authored by Servomex.

About Servomex

For more than 70 years, Servomex has been at the forefront of gas analysis innovation, helping customers around the world improve process efficiency, product quality, safety, and regulatory compliance.

As a global leader in gas measurement solutions, Servomex designs, manufactures, and supports a comprehensive range of gas analyzers and sensing technologies for industrial, environmental, semiconductor, healthcare, pharmaceutical, energy, and research applications. The company's portfolio includes solutions for oxygen, moisture, trace impurity, and multi-gas analysis, delivering accurate and reliable measurements even in the most demanding operating conditions.

What sets Servomex apart is its unique combination of technology expertise and sensor manufacturing capability. By developing and producing many of its own core sensing technologies, Servomex maintains complete control over performance, quality, and long-term reliability. This enables customers to benefit from market-leading accuracy, low cost of ownership, and dependable operation throughout the analyzer lifecycle.

Servomex supports customers globally through dedicated engineering, service, and application teams, providing expert guidance from specification and installation through to maintenance, calibration, and long-term operational support.

With a commitment to continuous innovation and customer success, Servomex helps industries worldwide achieve greater productivity, sustainability, and operational confidence through trusted gas analysis solutions.

Servomex is part of Spectris Ltd, the productivity-enhancing instrumentation and controls company. Spectris is a leading supplier of productivity-enhancing instrumentation and controls.


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Last updated: Nov 9, 2026 at 9:51 AM

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