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Applied News
Month: November 2013
Maintaining Your Oxygen Equipment: 3 Easy Steps
Maintaining Your Oxygen Equipment: 3 Easy Steps 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! DAILY Each Fill Day, youll need to calibrate your paramagnetic analyzer. The paramagnetic analyzer (such as the popular Servomex) is NOT the same as a handheld analyzer. It is a sophisticated analyzer that can gauge the purity of your oxygen drug product, and is a required step in filling gas cylinders. You should calibrate your analyzer with special oxygen and nitrogen created for this purpose, and that comes with a valid COA (Certificate of Analysis). Click here to see our calibration gases. ANNUALLY Your filling equipment is used in the manufacture of a drug product, and must be maintained according to the manufacturers standards, or FDA requirements. Heres what we recommend for some essential filling equipment. Gauges and Thermometers Vacuum and High Pressure
Free Sample Of American Made CPAP Tubing
Made in USA FDA Compliant! Applieds CPAP tubing is made from materials that comply with FDA specifications 21 CFR 177.1520 and 21 CFR 177.1210. All tubing is constructed from materials that comply with ISO 10993/FDA standards for cytotoxicity and biocompatibility. Our tubing is manufactured in a FDA compliant facility, fromlatex free, all virgin raw materials and is made in the USA. Applied Standard 6ft CPAP Tubing Sign up for a free sample! Applied CPAP tubing has soft 22mm cuffs so its easy for patients to slide on to their devices, flexible 19mm tubing and is light weight to keep from pulling on masks during sleep. Also Available in Ergonomic Tubing Applied Ergonomic tubing is a lightweight medical tubing for CPAP and respiratory therapy. It has exceptional strength with a smooth interior and corrugated exterior that allows for quiet, kink free operation. Slimline Tubing Applieds Slimline tubing is designed with a popular Ergonomic Cuff design. Slimline
OxySafe
What is OxySafe? OxySafe is a thermal fuse designed to stop the flow of gas in the event that the downstream cannula or supply tube is ignited, and will meet VA, ISO and other regulatory requirements. With OxySafe, the PVC tube is inclined to extinguish because PVC will not normally burn in airoffering healthcare providers a cost effective solution to lower the risk of serious patient injury in a dangerous oxygen fire. You can download our OxySafe brochure here. Where Do I Use OxySafe? OxySafe should be placed as close to the patient as possible AND as close to the source as possible. This means that, ideally, you would outfit a patient with 2 OxySafes. This way you can protect the patient and others by protecting the oxygen source from fire. If you only put OxySafe in the middle of the circuit (say in between two 7 foot supply tubes) you may not protect the source, and you run the risk of the fire spreading regardless of the OxySafe extinguishing the cannula tubing- as the
New Labeling and Hazcom Training Requirements
GHS, or Globally Harmonized System of Classification of Labeling of Chemicals, is a system used world wide to standardize the labeling and safety data sheets for chemicals. Because there are so many chemicals and hazardous substances used world wide, GHS strives to make everyone safer by creating a universal communication system. THe GHS is not a regulation body in and of itself, but rather a set of standards that regulatory bodies can adopt to create a uniform system across the globe. Think of GHS as akin to the metric or imperial system- metric or imperial are not themselves a regulation, but something that regulating bodies adopted. Similarly, GHS has recently been adopted by OSHA, the Occupational Safety and Health Administration of the Federal Government, to standardize hazardous material safety in the US. This means that the way things look on the chemicals you use and the material safety data sheets you see will change. Each company will need to train employees on the key
Are you correctly using lot stickers?
According to the CGMPs, each manifold filling sequence, each uninterrupted filling sequence, every 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. For firms filling liquid oxygen for delivery to home patients, each of the 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. The assigning of a single lot number for an entire days production is not acceptable. 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 these procedures are performed from the beginning to the end of a process they provide assurance that the batch is uniform and consistent. As such, each batch is in itself a separate entity with its filling operations unique to that filling sequence. At the present time, cryogenic
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