Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
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Last Updated on May 14, 2021 by The Health Master
FAQs on Medical Oxygen
Q. 1 Is medical oxygen a drug ?
Ans; Yes, it is a drug. IP 2018 gives two monographs for ‘Oxygen’
Q. 2 How medical oxygen is manufactured ?
Ans:
From atmospheric Air: – Air is separated in to oxygen, nitrogen carbon dioxide etc when passed through molecular sieve bed where nitrogen, water, carbon dioxide and trace hydrocarbons are adsorbed preferentially by the molecular sieve leaving a high purity stream of oxygen gas. Also called cryogenic distillation process. (for both medical or industrial use)
Trans fillers: – Transfer of oxygen (may be liquefied oxygen or gaseous oxygen) from larger to smaller containers (High pressure cylinders or cryogenic vessels).
Q. 3 Whether license is required for sale and manufacturing of oxygen under Drugs and Cosmetics Act 1940 (D&C Act) ?
Ans: Yes. The provisions under the Act require sale as well as manufacturing license for medical oxygen (Oxygen IP as well as Oxygen 93% IP) subject to following exemptions under Schedule K:
Oxygen 93% IP as well as Oxygen 93% USP are exempted from manufacturing license produced from air by the molecular sieve process by a hospital or medical institute for their captive consumption
Oxygen 93% supplied from liquid oxygen by a hospital or medical institute for their captive consumption
Note: – No such exemption PROVIDED for those units engaged in manufacture of oxygen for commercial use (other than hospital or medical institute use). Such commercial use not exempted even from sale license.
Q. 4 What are the monographs for oxygen in IP 2018 ?
Ans:
Oxygen IP (Purity not less than 99% v/v O2)
Oxygen 93% IP (Purity not less than 90% v/v to 96% v/v O2)
Q. 5 Labeling requirements of oxygen as per IP ?
Ans:
For Oxygen 99% v/v:
1. The shoulder of cylinder should be painted white and rest of cylinder black
2. Cylinder should carry a label stating ‘Oxygen’
3. In addition to above the words ‘Oxygen’ or symbol ‘O2’ should be stenciled in paint on the shoulder
For Oxygen 93% v/v:
1. Each outlet must be labelled ‘Oxygen 93 Percent’ when it is directly piped from tank to point of use
2. If cylinders :- than white & black paint as above and cylinder to carry label ‘Oxygen 93 Per Cent’ & ‘ For medicinal use’
Q. 6 What are storage requirement for Medical Oxygen ?
Ans:
Oxygen 99% : Under pressure in metallic cylinders
Oxygen 93% v/v : In metallic cylinders or low pressure collecting tank
Q. 7 What is difference between medical and industrial oxygen ?
Ans: Both are basically oxygen and obtained the atmospheric air. Medical Oxygen is subjected to mandatory regulatory manufacturing as well as quality checks as per the statutory requirements under IP / BP / USP etc
Q. 8 Whether industrial oxygen can be used for medicinal purposes ?
Ans; No, it is not allowed / recommended. However, use of industrial oxygen for medicinal purposes inadvertently or in emergency cannot be denied.
Q. 9 Whether medical oxygen covered under MD Rules 2017 ?
Ans: No.
Also read More FAQs, click here
Q. 10 What are the storage arrangements made for stocking medical oxygen ?
Ans: The premise should have arrangement of fire fighting equipment.
Q. 11 Whether Medical Oxygen comes under essential commodity or Essential Commodities Act?
Ans: Yes, as it is a Drug.
Q. 12 What is the color of industrial oxygen cylinders?
Ans: Industrial oxygen cylinders are grey in color.
Q. 13 What is the system to allot batch no. to the Medical Oxygen?
Ans: This is the continuous process to provide batch no. to the Medical Oxygen.
Q. 14 Hospitals which store oxygen in the tank and purchase oxygen from other source through proper bill. Do they required any storage license ?
Ans: Yes, they require storage license for department of Explosives.
Q. 15 Firm who are filling Medical Oxygen, can also fill other industrial gases or oxygen for industrial purposes?
Ans: These manufacturing premises must be used exclusively in production of Medical oxygen only. (No other manufacturing activities shall be undertaking except in respect of units licensed prior to 11-12-2001.)
To read all FAQs of the author, click here
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