Applied News

Month: September 2013

Who needs training?

September 25, 2013 by Kristen Ci

In any manufacturing operation involving human manipulation there are hazards which may be created by preoccupation, mental lapse, carelessness and the like. Therefore, all on-the-job and CGMP training should be revisited at frequent intervals and needs to be conducted by qualified individuals. A firm is expected to establish detailed written procedures (training program) outlining the specific areas of the firms operation to be covered. On-the-job training is acceptable, as long as the training is conducted by a qualified individual on a frequent basis. Any employee involved in the manufacturing, filling, processing, handling, holding, or shipping of a medical drug is required to be trained both on-the-job and in the current good manufacturing practices. This would include all delivery and/or truck drivers who deliver medical drug products. The lack of CGMP training is one of the most overlooked areas observed at most medical gas firms. CGMP training should be conducted by qualified

Posted in General

Its in the Bag! Patient Cylinder Bags

September 23, 2013 by Victoria Marquard-Schultz

Keep Patients- and your wallet- happy with these well made bags. Looking for just the right bag for you patient? Weve broken it down for you. Check out our picks below. Most Versatile This versatile M6/B 3-in-1 Cylinder Bag can be carried horizontally, vertically or as backpack and features clear window to easily see regulator. Best Features Use this roomy Premium Stylish M6/M9 Cylinder Backpack to carry up to 2 cylinders at a time! This pack features a light blue accessories bungee cord and convenient zippered accessory pouch on front, padded back, backpack straps and comfort carry handle. Best for a D Cylinder Comfortably carry a D cylinder in this premium pack: This D Cylinder backpack features a bungee for accessories, padded shoulder straps and a sternum strap with a cannula caddy. Best Fanny Pack Keep your hands free with this sturdy M6/B/M9/C Fanny Bag. Best for Multiple Cylinders Carry 2 M6 cylinders- any way you want to-

Posted in Patient Bags, Product Reviews

How to Stop Patient Cannula Fires

September 23, 2013 by Victoria Marquard-Schultz

According to the Joint Commission-NPSG.15.02.01 EPs 2 and 3 require home care organizations to provide education to the patient and family regarding causes of fire and fire prevention activities. So the question is, what education are accreditation agencies looking for besides telling the patients not to smoke or be near an open fire when using their oxygen? Accreditation agencies expect that patient education include the common causes of household fires, how oxygen enhances fires and a comprehensive list of what preventative actions need to be taken by the patient using oxygen. This education can be provided orally, or in writing (such as in a pamphlet), or preferably both. Additionally, with the education, we at Applied recommend also outfitting patients with a thermal shut off device, such as Applieds OxySafe, to help prevent damage when there is a fire. Oxysafe is a thermal fuse designed to stop the flow of gas in the event that the downstream cannula or supply tubing is ignited. With

Posted in OxySafe, Patient Safety, Cannula, VA

Training Time!

September 23, 2013 by Victoria Marquard-Schultz

Its Training Time! Heres A Break Down When You Should Be Training! Within 90 Days of hire If youve got a new hire, youll need DOT training within 90 days! FDA requires cGMP training, too, before you can let your new filler out on his own. Check out below for the training hell need. (But wait! If your new hire came with documented training, you wont need to re-train.) Annually and on a Continuing Basis Personnel training in Current Good Manufacturing Processes is required by law. (21 CFR 211.25) The Code of Federal Regulations and the FDA require that employees manufacturing, processing, packing or handling the drug have this training as it relates to the employees job function. This training must also be given on a frequent and continuing basis and be documented. A popular option for a variety of training are online classes in cGMP and our FDA Filling on Demand Online Course Certifications (or get the classes a la carte if you only have a few employees.) Every 3 Years The

Posted in Training, DOT, FDA, CGMP

New GHS Oxygen Label and Training Requirements from OSHA

September 20, 2013 by Victoria Marquard-Schultz

GHS, or Globally Harmonized System of Classification of Labeling of Chemicals, is a system used world wide tostandardized the labeling and safety data sheets for chemicals. Because there are so many chemicals and hazardous substances used worldwide, GHS strives to make everyone safer by creating a universal system. THe GHS is not a regulatory 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 different countries and regulatory 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. Youll also have to do some training for your

Posted in OSHA, GHS, Labels, Training, SDS

Are You Calibrated?

September 20, 2013 by Victoria Marquard-Schultz

If your equipment is used in the manufacture, processing, packing, and holding of a drug product it must be routinely calibrated, inspected, or checked according to a written program designed to ensure proper performance. Heres what we recommend for common oxygen equipment. Servomex Or Paramagnetic Analyzer Paramagnetic oxygen analyzers are required by the FDAs current good manufacturing practices. Paramagnetic oxygen analyzers are different from handheld analyzers because they are more precise, and the final testing for USP oxygen must be done with a paramagnetic analyzer. Your analyzer should be calibrated every fill day and sent in annually for preventative maintenance. Gauges and Thermometers High pressure gauges, vacuum gauges, and thermometers should be calibrated to NIST standards annually. NIST stands for National Institute of Standards and Technology. The FDA specifically references this standard in their Guidance for Industry. Pigtails Pigtails used on your

Posted in Calibration, Servomex, High Pressure Gauges, Thermometer, Pigtails, NIST Standards

What Cleaner Should I Use For My DME?

September 18, 2013 by Victoria Marquard-Schultz

Oxygen Equipment Oxygen equipment, such as regulators, conservers and filling equipment, should be cleaned with the unique properties of oxygen in mind. Any surface that comes into direct contact with oxygen (called the wetted surface), such as a cylinder valve opening, must be cleaned for oxygen service according to CGA standard G 4.1. This is to make sure that there is not particles left behind that could catch fire when oxygen and heat are introduced. Concentrators When cleaning concentrators, you should be mindful of using a cleaner or chemical that is oxygen compatible. While you wont need to clean to oxygen service (unless you are cleaning the concentrator barb inlet), the cleaner you use should leave no residue behind. The best part about this cleaner, is that it is not just for concentrators! Its great for beds, wheelchairs and more! Tough Dirt and Label Residue Adhesive and grime can be tough to scrub off cylinders... but be careful- cylinders have special

Posted in General

What is a QCU?

September 18, 2013 by Kristen Cif

The FDA requires each firm to establish a quality control unit (QCU). The QCU has the responsibility and authority to approve or reject all drug product containers, closures, in-process materials, labeling, written procedures, the authority to review production records to assure completeness and accuracy, and is responsible for the approval or rejection of all manufactured drug products. The responsibilities and procedures applicable to the QCU must be in writing and must be followed. The designated person(s) are required to meet the Personnel Qualification requirements [211.25], must be identified in the firms procedures, and must receive appropriate quality assurance training. This includes training in the particular operations that the employee performs and in current good manufacturing practice as it relates to the employees functions. A small firm may designate a single individual with the personnel qualifications. QCU managers and personnel can get the training they need fast

Posted in QCU

Getting more from your oxygen business

September 12, 2013 by Jim Christ

Jim Christ travels the nation, installing transfilling systems, training providers and has just about seen it all in his 10 years of experience. Heres some of his most popular tips for getting the most from your oxygen business. Formula for success Have a consistent approach in the structure and operation of your drug manufacturing facility. Having policies and procedures that all applicable employees can understand is essential when transfilling. All employees should be trained to follow these procedures and understand what is expected of them. Setting up a consistent company structure can fortify the expectations that go along with being a drug manufacturer. First steps Dont just assume that everyone is doing everything they are supposed to do. Regulatory bodies dont. Have systems in place to double check that all of the requirements are being met when it comes to drug manufacture. Perform regular audits of your procedures, staff, and records or have an outside agency do it

Posted in Transfilling, System, Tips And Tricks, Better Oxygen Business

What is cGMP and why is it important?

September 05, 2013 by Kristen Cifranic

The Food, Drug and Cosmetic Act states that a drug, such as medical oxygen is adulterated and subject to legal action if it is not manufactured in accordance with the current good manufacturing practices (CGMPs), or does not comply with appropriate official standards such as strength and quality as cited in the United States Pharmacopoeia/National Formulary (U.S.P./NF). So what does that mean to Oxygen Providers? Heres an example. Terry, who owns a struggling home health care business in a ruralarea, decides to save money by supplying his patients with industrial oxygen rather than the more costly medical oxygen. He has a local welding distributor deliver industrial oxygen cylinders to his garage where he removes the cylinder labels, places the unlabeled cylinders in the bed of his pickup truck, and delivers them to patients. One of Terrys patients is severely injured from breathing oxygen contaminated with acetylene gas. The FDA is notified and with the aid of U. S. Marshals seizes

Posted in CGMP, Supplying Medical Oxygen

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