FDA does NOT recommend using soap and water solutions to leak test oxygen cylinders. These solutions leave residues on the valve that, when they come in contact with high pressure oxygen, can ignite and cause a fire. Read this article on how to properly leak test your
The Proof is in the Pudding for Policy & Procedure Manuals All providers must have a written policy and procedure manual. No matter what type of inspector or accreditor, they all require that you write your processes down. Not only is it good business, but it's also required. Luckily, most of the requirements from the different agencies overlap between agencies. What are SOPS or a Policy & Procedures Manual? Written Procedures, SOPs, or policy and procedures manual is a manual describing the procedures your company follows for the cleaning of equipment, quality control, calibration procedure, security requirements and other procedures followed by your company when following the cGMP. How do they work? The key with the required written procedures is to be sure to follow what you have written. If there is ever any deviation from the written procedures, they must be documented. The person who creates the procedures must sign and date them. The QCU must review and approve these written procedures and any deviations from them by signing and dating the procedures. What should it cover? Some highlights are: job descriptions, company organizational chart, equipment cleaning schedules, training programs and security programs. For oxygen fillers (liquid to liquid, liquid to gas or gas to gas) there are also requirements for handling the drug product and following cGMP. I've written them, now what? It does little good to enact new procedures and controls if th
Applied is one of the leading medical oxygen regulator suppliers in the home healthcare
OxyGo LLC, a leader in lightweight portable oxygen concentrators, has acquired LIFE® Corporation, a manufacturer of medical devices that specializes in portable Emergency Oxygen and CPR administration
Are you and your employees meeting required training
Oxygen is very safe to have in the home, as long as these guidelines are followed. Are the following 16 tips included in your oxygen safety training for your
Most popular disinfectants and other infection control products may contain ammonia and other harmful chemicals banned by the CGA for
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
FDA guidance requires that filling equipment be calibrated at specific intervals, depending on the type of equipment. Don't forget you need to document all calibration!
Here are four regulatory rules you should follow when transporting, moving, and storing or working with compressed gas
Did you know the US Department of Transportation recently announced an update to the cylinder requalification policy update due to the emergency response of COVID-19 and will be valid for the entirety of the emergency
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