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Applied News
Month: May 2014
Pigtail Best Practices
Pigtails used on your transfilling system, if maintained properly, can last for years. Everytime you fill, you should visually inspect your pigtails for damage. If there are kinks or weak points, such as from folding, the the pigtails could snap from the high pressure and become dangerous to you or others. Additionally, Applied recommends that your pigtails used with transfilling systems be tested annually to ensure that they are safe for use. You should also test them if you suspect there might be a problem with them. Perform the following inspections on pigtails. If the pigtail fails any inspection it should be removed from service and either repaired or replaced. Dont forget to wear proper safety equipment when testing high pressure equipment. *Visually inspect pigtails for corrosion, kinked areas, crimps, or any other external damage. * Spray the pigtail and its connection point with an oxygen compatible leak testing solution. The solution will form large bubbles if a leak
Handy Calibration Chart From Applied
FDA guidance requires that filling equipment be calibrated at specific intervals, depending on the type of equipment.Dont forget you need to document all calibration! Equipment should have annual calibration according to NIST standards, National Institute of Standards and Technology. Click on the links below for more information. Equipment Each Fill Day Annual Recommended Standard Vacuum Gauges Send in your gauge: 1120-0058V New gauge with calibration: 1110-0420C X X NIST Thermometer Send in your thermometer: 1120-0058TH New Thermometer with calibration: 1108-0115-1 X NIST High Pressure Gauges Send in your gauge: 1120-0058HP New gauge with calibration: 1120-0057C X NIST Servomex (ParamagneticOxygen Analyzer) Servomex PM: OF-936 New 5200: OF-940 X X Manufacturers Manual
Lots 101
According to the CGMPs, each manifold filling sequence, each uninterrupted filling sequence, each cryogenic vessel filled and each storage tank following a delivery is considered a new lot and is required to be assigned a new lot number. The assigning of a single lot number for an entire day production is not acceptable, you must do so by batch.A manufacturing operation, such as the filling of high pressure cylinders on a multi-outlet manifold, is governed by a set of manufacturing procedures or conditions. When the procedures are performed from the beginning to the end of a process they provide assurance that the batch is uniform and consistent. Therefore,each batch is a separate entity with its filling operations unique to that filling sequence. For firms filling liquid oxygen for delivery to home patients, each ofthe large cryogenic vessels or dewars (either portable or permanently mounted in a van or a truck) are required to be assigned a unique lot number. At the present time,
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