Must Oxygen PSA technology be harmonized with European Pharmacopoeia? In Europe we have the European Pharmacopoeia that it's mandatory in all the country of the European Union. The Pharmacopoeia defines the quality standard of all the medicinal product, the active substance and the recipient. At the moment in the Pharmacopoeia it exists only one type of oxygen and so only one monograph stating that the medical oxygen needs to have the title > 99,5%. This title is mandatory for the oxygen to be defined as a medicinal product and to be authorized by the competent authority (ministry of health, agency).
Yes, the information is right. Currently there are 37 members of the European Pharmacopoeia Commission: Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Republic of Macedonia, Turkey, United Kingdom, and the European Union. In these countries and the European Union the Ph. Eur. is the official pharmacopoeia which defines the standard of medical oxygen. PSA technology does not produce the medical oxygen, PSA produces oxygen enriched air - European pharmacopoeia does not define this type of oxygen/air so there is no reason to be complied with this standard. PSA technology and oxygen enriched air are defined in ISO 10083.
Oxymat Oxygen generating systems were successfully installed also in Europe. I would like to point at the countries which are members of the European Pharmacopoeia and PSA plants were installed there: Romania, Italy, Norway, Slovakia, France, Netherlands, Spain, Poland and Turkey. Well, in a short, it is just the decision of the concrete hospital if they prefer to be supplied by 99.5% oxygen (it is a liquid oxygen) or if the hospital decides to own its on-site oxygen generator (PSA technology able to produce oxygen up to 95 %), because there are a lot of advantages to have the on-site oxygen generating system.
How is Oxygen PSA classified?
The on-site oxygen generating plants are classified as Medical Device and they need the CE approval to be commercialized. The CE approval is given by a Notified body only if the device respects totally a harmonized norm. The harmonized norm in this case is the ISO 10083. The on-site plant could be certified as a Medical device on the basis of this technical requirement for any oxygen title because it's independent form the quality of the product - and Oxymat PSA plants are classified as the Medical Device, are CE approved and harmonized within ISO 10083. So our products fulfill all neccesary and strict norms valid for PSA technology.
Why is PSA recommended to be chosen as the only Oxygen source for hospitals?
There are a lot of advantages to have the own on-site oxygen generating system:
- Product flexibility and self sufficiency – independence from oxygen suppliers
- Controlled flow – uninterrupted oxygen supply in exact quantity and quality needed, 24/7
- No evaporating effect: gas oxygen does not evaporate in comparison with liquid oxygen (there is up to 10 % evaporation from tanks with liquid oxygens)
- Cost effectiveness – low maintenance cost and long-life span
- External cost – no more rental, freight and handling cost
- Rapid on-line time and high reliability
- Full automation
- Independent on-site production
- Top performance in relation air/oxygen
- Competitive pricing
- Safe delivery – well proven design, high quality components
- Easy to install, operate and maintain
Why do not hospitals know Oxygen PSA technology option?
For last years, there was not so much information about PSA technology so many hospitals were not informed about this option. They know just liquid oxygen and medical oxygen which have been using for many years. But in fact, there are various options on the market just to let you know about these possibilities. Nowadays we have the customers/hospitals which use the Oxymat PSA units as the only source of oxygen (for breathing, for surgery, for anything in the hospital) and they are pretty satisfied because PSA technology is absolutely reliable and cost-effective solution.
Is 99% oxygen necessity for hospitals?
99 % oxygen is needed mainly for laser cutting and welding (for these applications the liquid oxygen is used). There is no need to produce and use 99% oxygen in medical/human body application for breathing and saving the lives. Whereas people can breath oxygen from 20 % to 30% - 99% oxygen (and analog) 95% oxygen must be diluted on required level. And finally, as you know, 99% oxygen is toxic for human body. On the other hand and from economic point of view, production of 99 % oxygen by PSA is very cost non-effective and expensive. Liquid oxygen is preferred for 99% oxygen applications.
