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Month: April 2020

Are You Meeting Pre-Fill Requirements?

Are You Meeting Pre Fill Requirements

Posted By Laura Frederick
April 07, 2020 Category: General

When filling medical oxygen cylinders it is critically important now more than ever to perform pre-fill odor testing as part of the required nine (9) pre-fill checks.  We wanted clarify and stress the importance of the absolute safety and regulatory requirement of pre-fill odor testing every medical oxygen and air cylinder prior to filling.    The latest USP 99 monograph dropped the requirement for post filling odor testing, however we strongly recommend continuing to perform the post odor testing as well.  Please review the pre-fill steps below and ensure you are following this cGMP requirement. Pre-Fill Inspection  Verify hydrostatic test date is current Aluminum cylinders must be within 5 years Steel cylinders must be within 10 years if star is present Verify correct cylinder color In United States oxygen color is green In Canada and many other countries oxygen color is white Perform hammer test on steel cylinder only.  Aluminum cylinders are exempt. Strike outside of cylinder with a hammer and listen for ringing or bell sound Perform visual inspection of the cylinder body Ensure no external damage or any type of residue on the cylinder Perform visual inspection of the cylinder valve Ensure no external damage or any type of residue on the valve Perform a label examination Ensure a product label exists and that it is not damaged If damaged or unreadab

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