Quality of delivered product from medicinal gas cylinders add.1

Doc 209/17add 1 - Revision of Doc 209/17

This publication has been prepared by the European Industrial Gases Association to present data that shows that metallic particles do not migrate from medicinal gas cylinders in quantities that could be considered toxicologically relevant.
Medicinal gases are authorised according to European Union Directive 2001/83/EC as medicinal products, this includes their container closure system, which in the case of gases consists of cylinders and valves.

No serious adverse reactions have been detected through the pharmacovigilance systems of the EIGA Member Companies arising from inhalation of particles migrating from the gas cylinder.

EIGA have conducted analytical tests in order to measure metallic elements, that could be present in medicinal gases. The results have concluded that impurities measurements are below the detectability levels as well as below ICH Q3D requirements.

EIGA is therefore of the opinion that the medicinal gases including their container closure systems do not present any risk to the patient by migration of metallic particles in toxicologically relevant quantities. Consequently, leaving the benefit-risk balance of medicinal gases unchanged. This publication explains in detail the tests conducted by EIGA Member Companies to confirm the physical view point of flows inside of gas cylinders.

This addendum includes additional test results as well as new section on cylinder selection criteria.

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Table of Contents
1 Introduction
2 History of medicinal gases
3 Types of gas cylinder package
3.1 Gas cylinders
3.2 Gas cylinder valves
4 Filling of gases into gas cylinders
5 Internal condition of compressed gas cylinders
6 Pharmacovigilance
7 Testing of medicinal oxygen from gas cylinders
7.1 Test objectives
7.2 Cylinder selection
7.3 Sampling method
7.4 Analysis results
7.5 Internal observations of cylinders (cylinder bottom and walls), Cylinder pictures (Batch 1) ..12
7.6 Internal observations of cylinders (cylinder bottom and walls), Cylinder pictures (Batch 2) ..16
7.7 Discussion of analytical results
8 Conclusions
9 References
10 Other References

Fonte: EIGA

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