Importance of Regular Calibration for Transfill Systems
...nsfill systems play a crucial role in ensuring a consistent supply of oxygen. This is where regular calibration of transfill systems becomes essential.
What is a Transfill System?
A transfill system transfers oxygen from a larger ... Is your Servomex analyzer calibrated correctly?
...analyzer as required?
Oxygen analyzers are required to be calibrated each fill day with a specialty calibration gas that has a COA like our calibration gases. The FDA does not allow USP oxygen to be used to calibrate analyzers. (... I Fill Oxygen
... requirement.)
Click Here for more information about our training and certification programs.
2. Calibrations
FDA guidance requires that filling equipment be calibrated at specific intervals, depending on the type of equipment. ... Maintaining Your Oxygen Equipment: 3 Easy Steps
...ted 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 popul... Handy Calibration Chart From Applied
...ated 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 Technol... What Are Spec Gases? Why Do I Need Them?
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... The Critical Role of Pressure Gauges in Oxygen Systems
...ure gauges must be maintained and calibrated annually to ensure continued accuracy and reliability. Calibration ensures that the readings remain precise and compliant with safety regulations.
FDA guidance requires that fillin... Cylinder Handling After a Natural Disaster
...m natural disaster areas must be separated according to their hazard class. Oxidizing and flammable gases should be kept at least 25 ft apart. The cylinder label provides information on its contents and hazards. The transportatio... Filling Liquid Oxygen
...gularly, as recommended by the manufacturer or based on past validation (at least once a year).
All calibrations should be verified against standards set by the National Institute of Standards and Technology (NIST).
Home cryog... Maintaining Your Oxygen Equipment
...d at specific intervals, depending on the type of equipment.
Dont forget you need to document all calibration!
1. Daily
Each fill day, youll need to calibrate your paramagnetic analyzer.
The paramagnetic analyzer (such ... Links
...Up your FDA Labeler and Product Code
FDA Guidance Documents
2003 FDA Draft Guidance for Medical Gases
1989 FDA Guidance for Medical Gases
Gas Certification Draft Guidance
FDA internal Guidelines for 483 Warning Letters... Cryogenic Hoses: The Basics
What is a Cryogenic Hose?
A cryogenic hose is used to transfer liquid gases (like medical oxygen) from one container to another. For example, from a VGL to a home unit.
What is CGA 440?
CGA 440 is a type of connection. All... About
...call Applied to place an order or get solutions for your questions. We know that behind the tools, gases, and cylinders lies something even more important: your patients. Whether youre calling Applied with an order or simply a q... Ensuring Compliance with Transfilling Regulations
...ts regulatory standards is the first step towards compliance. This includes regular maintenance and calibration of transfill systems to guarantee accurate and safe operation.
Essential Equipment Maintenance Practices:
Regular Insp... Servomex 5200 vs. Handheld Analyzers
...DA Pharmacopoeia 23.
Oxygen is magnetic! Oxygen is attracted to a strong magnetic field most other gases are not. This para-magnetism is used to obtain fast, accurate measurements.
If your oxygen analyzer reading is 99.5%, then... Equipment Calibration: Are you up-to-date?
...ed with transfilling systems be tested annually to ensure they are safe for use.
Regular equipment calibration is an essential part of ensuring the quality and safety of medical oxygen. To learn more about equipment calibratio... The importance of purchasing quality regulators from suppliers
... include evaluation of damage, material degradation due to aging, contamination, wear, performance, calibration, etc. Inspections should be performed by the manufacturers authorized agent or the device manufacturer.
Can I rep... SOPs: Write it Down!
...nual 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... New GHS Oxygen Label and Training Requirements from OSHA
... the relate to our industry are:
Gas Cylinder: Gases under pressure Flame over Circle: Oxidizers
3. If you are an oxygen filler, youll need to ... Cylinder Valve Connections
...as Association (CGA). This connectionsystem is designed to help reduce mix-ups involving compressed gases. We willexplain the differences between the types of valves.
Post Valve Connections:
Require a tool of some sort to open t... Cylinder Valve Connections
...the Compressed Gas Association (CGA) to help avoid any confusion with different types of compressed gases.
When it comes to Post Valve Connections, you will need a tool to open them up. These connections rely on a pin indexing system... DOT Law for Home Medical Oxygen
...transported, an oxygen placard is sufficient. If transporting oxygen along with other non-flammable gases, both placards may be displayed.
Shipping Papers: When They Are Required and What Must Be Included
Shipping papers... live-stream
...is the author of several popular copyrighted workbooks, courses, and seminars on compressed medical gases, regulatory requirements, and safety. He has been a seminar speaker at national industry events including MEDTRADE since 2004 and... Medical Oxygen Regulators FAQ
... include evaluation of damage, material degradation due to aging, contamination, wear, performance, calibration, etc. Inspections should be performed by the manufacturers authorized agent or the device manufacturer.
4. Can I repair or modi... Choosing quality regulators
... include evaluation of damage, material degradation due to aging, contamination, wear, performance, calibration, etc. Inspections should be performed by the manufacturers authorized agent or the device manufacturer.
4. Can ... What is the DOT Rule on Carts and Racks?
...ivers any amount of oxygen. (This jurisdiction is found in 49 CFR 171.1)
The DOT dictates that all gases (class 2 materials) when transported be securely restrained in an upright or horizontal position, loaded in racks or packed in bo... Are you using the right disinfectant?
...t instructions before using any product or service in or around medical oxygen and other compressed gases and equipment. Check out our full line of disinfectant below!
OxyGo COVID Killer Disinfectant
COVID Killer utilizes a... 2015 Label Updates!
..., and our liquid labels. They will include the yellow Oxidizer symbol, as well as the Gas Cylinder: Gases Under Pressure pictogram. A size and content chart will be at the center right, and your custom contact information will... New Labeling and Hazcom Training Requirements
...on involving these chemicals to be consistent.
Some the relate to our industry are:
Gas Cylinder: Gases under pressureFlame over Circle: Oxidizers
3. If you are an oxygen filler, youll need to make sure your oxygen drug ... You Become Who You Hire
...piratory equipment and is the author of several videos, workbooks and courses on compressed medical gases, regulatory requirements and safety. He has been a seminar speaker at national industry events since 1981.
... Servomex 5200 and Handheld Analyzers
...A Pharmacopoeia 23.
Oxygen is magnetic! Oxygen is attracted to a strong magnetic field most other gases are not. This para-magnetism is used to obtain fast, accurate measurements.
If your oxygen analyzer reading is 99.5%, then your... FDA Registration Renewal for Transfillers: What You Need to Know
... renewal for transfillers.
Who Needs to Register?
Any company involved in transfilling medical gases must register with the FDA. According to the FDA, this means that any firm that transfers oxygen from one container to anot... Cylinder Requalification Policy Update
... increased demands, many medical and industrial gas suppliers are having a difficult time supplying gases, such as oxygen, and consistently obtaining cylinders.
PRE-PANDEMIC POLICY
Regular requalification of each cylinder ... Oxygen Drug Product Label FAQ
..., and our liquid labels. They will include the yellow Oxidizer symbol, as well as the Gas Cylinder: Gases Under Pressure pictogram. A size and content chart will be at the center right, and your custom contact information wil... NEW OSHA Requirements For Oxygen Cylinder Labels
...e new labels will use two of the GHS symbols, one for oxidizers (a flame over a circle) and one for gases under pressure (cylinder).
FDA DOT: Upcoming Changes
FDA requires the name of the manufacturer on the label and t... Washers in Oxygen Systems: An Essential Component
...units benefit from the lightweight properties of aluminum.
Why Keeping Washers Free from Oil and Gases is Essential
In oxygen systems, maintaining washers free of oil, grease, and contaminants is very important. Oils and oth... Applied\'s Handy Calibration Chart
If it has been 30 days or less since you received your item, please reach out to us for an RMA (Return Material Authorization). Some items may require a restocking fee, and some special-order items and medical devices may not be eligible for return. Click here to view our full return policy.
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