Applied News

Month: February 2014

Updated 2014 Applied Regional Seminars FAQ

February 27, 2014 by Victoria Marquard

Theres a lot going on with oxygen: Its a drug, its a hazardous material, accreditation has rules, the government has rules and its impossible to keep them all straight! Applieds experts have created a full day seminar covering how to handle, transport and fill oxygen- as well as other accreditation topics to help home care providers keep up with changing regulatory and technical information. Applieds all new 2014 FDA, DOT, OSHA Accreditation Seminar covers everything you need to meet oxygen training requirements: 1. Oxygen Safety (Accreditation OSHA, FDA DOT required) Properties of Oxygen Oxygen Safe Handling Cylinder Safe Handling 2. Delivery (DOT Accreditation Required) Job Specific Training HazMat Security Awareness Training HazMat Safety Training Shipping Papers Using the NAERG 3. FDA cGMP Training (FDA Accreditation Required) Registration Paperwork Required Forms New Labeling Requirements Filling Procedures Inspections 4. OSHA NEW labeling requirements and

Posted in General

What Are Spec Gases? Why Do I Need Them?

February 26, 2014 by Kristen Cifranic

Spec Gases While transfilling oxygen gas all manufacturers are required to use a paramagnetic oxygen analyzer to determine the identity and strength of the gas. Prior to using the analyzer it must be calibrated to manufacturers requirements. In order to calibrate these analyzers the manufacturers require the use of specified (spec) or calibration gases that will provide the analyzer with a benchmark to compare to. Spec gases should include a COA (Certificate of Analysis) from the supplier of the gas. The COA should include the actual results of purity of the gas when analyzed by the supplier. When introducing gas from the spec gas cylinder into the analyzer be sure to use a low pressure regulator that limits the flow of gas to less than 10 psi. The common analyzer brands that are used in the compressed gas industry are Servomex and Oxigraf. The specific spec gas requirements for each analyzer are shown below. Servomex Nitrogen certified: This gas is used to calibrate and adjust the

Posted in Specifiedgases, Calibrationgases, Calibratingoxygenanalyzers, Servomex, Oxigraf, Paramagneticoxygenanalyzers, Nitrogencertified, Oxygencertified

What is ISO 8359?

February 19, 2014 by Kristen Cifranic

ISO 8359 is a standard that describes safety requirements for oxygen concentrators. It has recently had someamendments passed that effect how the oxygen concentrators are used in the home care industry. ISO, or the International Organization for Standardization is a worldwide federation of national standard bodies that works together to create industry standards. Depending on the country, accreditation body or other organization that you belong to, you might have to comply with ISO standards. In the US, they are not federal law- but are often followed by accreditation bodies or other inspectors. ISO 8359 was amended recently to include the benefits of new oxygen technology, and because the ISO had new information regarding the role of oxygen concentrators in accelerating fires in the home that have been caused by patient smoking while undergoing oxygen therapy. The ISO recognizes Although these changes cannot prevent such fires, it is hoped that the severity of such fires can be reduced

Posted in ISO8359, OxySafe, Oxygenconcentrators, ISOstandards

Training by Personnel

February 12, 2014 by Kristen Cifranic

The FDA requires training on a frequent and continuing basis, usually interpreted to be about twice a year. The Quality Control Unit, and all Oxygen Transfilling Personnel should have proper FDA training for their jobs. Drivers need training as a requirement for FDA if they fill from a transfill system or if they fill liquid to liquid curbside. The DOT requires drivers to have training at least every 3 years, and within 90 days of employment for new employees. See the list below for all training options: QCU:The QCU, or the Quality Control Unit is the person or person(s) responsible for ensuring that the drug product is safe and high quality. They ultimately reject or accept all parts of the manufacturing process as meeting quality expectations. The QCU should have FDA training twice a year and should take at least one of each of the following classes: Oxygen Safety Oxygen 101 Online Class FDA cGMP Training Filling 101 Online Class Liquid 101 Online Class FDA Audits Seminar Servomex

Posted in Oxygentrainingbypersonnel, Oxygensafety, Fdacgmptraining,

Mini Oxygen Storage Audit

February 05, 2014 by Kristen Ci

Are your cylinders stored according to state and FDA regulations? Oxygen cylinders must be stored properly in order to prevent contamination, keep unauthorized personnel away from cylinders, and to prevent them from being damaged which can cause serious injuries. Take our mini storage audit below to find out if your cylinders are being properly stored: Storage Checklist Yes/No QCU initials Notes Cylinders are stored safely so they can not fall and cause injury or property damage Cylinders can be nested, or stored in carts or racks to keep them from toppling over Storage of oxygen is at least 10 feet away from source of open flame and 20 feet from combustibles Required under NFPA or UCC regulations. Check your state and local fire marshal for requirements in your area. Cylinder storage are clearly designated / signed, (ex, Full, Empty, Quarantine) FDA requirement to help prevent unapproved cylinders or cryogenic vessels from being distributed. DOT and

Posted in mini oxygen storage audit, FDA and DOT requirements for cylinder storage,

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