Cylinder And Liquid Container Issue
Related To Cylinder Conversion And Filling
During The COVID-19 Crisis
(Please click here to download a copy of the notice.)

Purpose

This guidance is consistent with SA-36, Safety Alert, Cylinder and Cryogenic Container Issue Related to Cylinder Conversion and Filling During the COVID-19 Crisis. CGA SA-36 is available to download from CGA’s website at https://portal.cganet.com/Publication/Details.aspx?id=sa-36 (also attached below).

During the Coronavirus Disease 2019 (COVID-19) pandemic, the demand for medical gas containers may rise due to increased demand.  It is important that measures taken to address this increased demand and avoid any potential shortages on a temporary basis are done so in a manner that does not cause a safety hazard to the filler or unacceptable risk to the patients who are the ultimate consumer.

This Safety Alert addresses interim measures that may be considered during this pandemic crisis if there is a need to convert high pressure cylinders or large portable cryogenic containers from industrial service to medical service to alleviate any potential shortage.

Safety Alert

This CGA Safety Alert discusses temporary measures to consider, if needed, during the COVID-19 crisis.

• Change of grade – converting high pressure cylinders into medical gas service of the same product
• DOT SP 21025 – temporary extension of requalification period
• Colors – considerations for color coding options
• “Top-fill” – vent and evacuation considerations
• SB-26 – tamper-resistant connection considerations on cryogenic containers

Key Considerations

• These are not mandatory measures and each item in the attached CGA Safety Alert should be carefully considered on a case-by-case basis depending on your local ability to address the demand for medical gases. Any temporary measures taken during the COVID-19 crisis should be discontinued when normal Current Good Manufacturing Practices, procedures and CGA standards can be reapplied and the crisis is over.
• The adoption of temporary measures should be formalized with:
  • Written “deviations” which are approved by your Quality Control Unit
  • Documented personnel training detailing the temporary measures
• When the temporary measures are retired, the process should be formalized with:
  • Closure of the “deviations” by your Quality Control Unit
  • Documented personnel training detailing the retirement of the temporary measures and restoration of your SOPs, FDA CGMP and CGA standards

Sample Templates

We have developed templates for the “deviations” from standard procedures as well as personnel training records you may use. These sample documents are in Word format and should be revised for your actual requirements.

These templates are available for the GAWDA Medical Gas SOP Program and for other compliance programs. Contact tom@asteriskllc.com for a copy of the deviation templates and sample training records. Indicate if you need the generic documents or the documents that are customized for the GAWDA Medical Gas SOP Program.