5/1/14 – Micro Audit

1.    Dead Ring Test – Verify that the dead ring test is actually being performed on high-pressure steel oxygen cylinders. Of course, the dead ring test should not be performed on aluminum cylinders. This simple item has appeared in recent FDA audits.
2.    Certificate of Analysis (CoA) – Be sure that the CoAs you receive for your bulk medical product and for your Servomex span/zero gas cylinders have the following mandatory items:
•    Name and address of the calibration standard supplier
•    Name of the product
•    Lot number or unique identification number specific for each cylinder
•    Analytical methodology used to assay the calibration standard
•    Actual analytical results (for example, 99.9 percent nitrogen)
•    The responsible person’s signature and the date signed