The Indian Pharmacopoeia Commission (IPC) in collaboration with Gas Industries Association (GIA) has rolled out a series of workshops to sensitize stakeholders on standards, testing methods and methods of conversions between industrial and medical oxygen to effectively tackle C-19 pandemic.
The basic difference between oxygen I.P. (medical oxygen) and industrial oxygen lies in assuring the quality control as per the specification demanded in the finished product to achieve with respect to the standard Indian Pharmacopoeia (IP) 2018.
Experts have emphasized that the process for manufacturing oxygen I.P. (medical oxygen) should be as per the requirements of Schedule M of Drugs and Cosmetics (D&C) Acts and Rules.
“The testing protocol as demanded by IP in its latest edition IP 2018 should be followed in oxygen I.P. (medical oxygen). To achieve this some process regulations are stringently followed in case of oxygen I.P. (medical oxygen),” explained Prasenjit Chakrabarti, senior manager Quality of Linde South Asia during the workshop. Linde is a leading industrial gases company in India.
Medical oxygen comes under purview of D&C Act 1940 & Rules 1945 as amended from time to time thereafter. State drug licensing authority issues license for manufacture for sale. The process of manufacturing is aligned with good manufacturing practices (GMP) through the requirement stated in “Schedule M” of the said rule.
Each and every “Batch” is being tested and only after complying with the specified limits as ascribed in IP 2018 the “Batch” is released. Medical oxygen is stored under pressure in metal cylinders of the type conforming to the appropriate safety regulations and labeling is done as per the guideline of IP 2018.
As per the guidelines, valves and taps should not be lubricated with oil or grease and chrome-plated valves are required as per IS requirement like IS : 3224 , IS 3745 Chakrabarti further explained, “In terms of storage, cylinders or low pressure tanks need to be used. containers used for oxygen 93 percent must not be treated with any toxic, sleep-inducing and narcosis producing compounds and must not be treated with any compound that will be irritating to the respiratory tract when the oxygen 93 percent is used.”
As per the labelling guideline of IP 2018, each outlet has to be labelled as “Oxygen 93 per cent” when it is piped directly from the collecting tank to the point of use. If it is through a cylinder, the cylinder should carry a label stating “Oxygen 93 per cent” and “For medicinal use”. Valves and taps should not be lubricated with oil or grease. Oil contamination is must avoidable for any oxygen service operator.
The common tests for both oxygen I.P. and oxygen 93 per cent are Assay (Purity Test). This has to be done by classical method using ORSAT Apparatus as per section 2.3.33 of IP 2018. In terms of impurities, the recommendation is that the Detector tube test be carried out as per section 2.1.1 of IP 2018.
The additional impurity test recommended for oxygen I.P. is water vapour. This “Water Vapour” test to be carried out by Detector tube test as per section 2.1.1 of IP 2018.
The industrial oxygen and medical oxygen can be both in liquid phase or gas phase. Labels are of high importance as oxygen I.P is a drug. It is recommended to always check the labels. The policy should be No Label, No Acceptance.
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