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Regulations for Medical Gases

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USP Medical Gas Revisions

On July 2, 2009, AsteRisk held a webinar to discuss the proposed USP Medical Gas Revisions. You may  download a handout from the meeting. 

 

 

 

 

 

Medical Gas Regulations

This site is a forum of information regarding licensing of medical gas firms. The information is location specific and is regularly updated.

 

We encourage you to submit comments about your experiences with the licensing process in your area.

The following information, organized by state, is available to all registered users:

  • License applications and forms
  • Full text of medical gas regulations
  • Summary of contact information, fees, expiration dates, etc.
  • Valuable user-generated input (what inspectors are looking for…)

 

Please contact us to register for an account.

 

Visit GAWDA Wiki 

Last Updated on Saturday, 08 August 2009 00:31
 

Proposed Changes in Medical Gas Testing

Saturday, 21 March 2009 23:18 administrator

The United States Pharmacopoeia (USP) is considering major changes to medical gas testing requirements

The latest USP journal Pharmacopeial Forum contains significant proposed changes for testing medical gases. This issue (July/August 2002 Vol. 28, No. 4) is due to be published within the next two weeks. Here are some of the proposed changes:

Oxygen

Assay ‚ the new test method is proposed to be the paramagnetic
oxygen analyzer. This would replace the wet chemical method.

 

 

Identity ‚ the new test method for identity would be included as
a part of the assay test.

 

Nitrogen

 

Assay ‚ the new test method is also proposed to be the paramagnetic
oxygen analyzer. This would replace the gas chromatograph method...
much faster!

 

Carbon Dioxide

 

Assay ‚ the new test method is proposed to be gas chromatography.
This would replace the Orsat wet chemical method.

 

Nitrous Oxide and Helium

 

Assay ‚ the new gas chromatograph column is 1.8 meters long.
This will result in much faster analyses.

 

Air

 

Oxygen content ‚ the new test method is also proposed to be the
paramagnetic oxygen analyzer. This would replace the electrochemical
method.

 

Gas Chromatographic Methods

 

GC parameters (temperature, flow, etc.) and system suitability parameters
(precision, resolution, etc.) would be explicitly specified. This would clarify
much ambiguity in the present monographs.

 

Remember that these proposed changes have a long way to go before they become official. First they are published in Pharmacopeial Forum. Then comments, with scientific justification, are received and republished, if necessary. Finally, some version of the new monographs would be published as a revision to USP. This process could take months... or years.

AsteRisk will continue to monitor Pharmacopeial Forum, and other sources, to bring you the latest information about medical gas compliance. We will post the latest information at www.AsteRisk-Inc.com.

Thank you,

Tom Badstubner

508 883 0927

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Last Updated on Tuesday, 11 August 2009 20:01