Slide background
Slide background

Quality of delivered product from medicinal gas cylinders

ID 4072 | | Visite: 1839 | Documenti Chemicals EntiPermalink: https://www.certifico.com/id/4072

Temi: Chemicals , EIGA

Quality of delivered product from medicinal gas cylinders

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.

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 Sampling method
7.3 Analysis results
7.4 Internal observations of cylinders (cylinder bottom and walls), Cylinder pictures (Batch 1)
7.5 Internal observations of cylinders (cylinder bottom and walls), Cylinder pictures (Batch 2)
7.6 Discussion of analytical results
8 Conclusions
9 References
10 Other References
Table 1 Description of cylinders and equipment used for particle measurement
Table 2 Particle measurements Scenario 1 9 sample results and scenario 2 6 sample results
Table 3 Application data and related calculations
Figure 1 Example of a cylinder valve and valve protection
Figure 2 Example of a gas cylinder package
Figure 3 Example of gas cylinder package with accessories
Figure 4 Schematic of equipment used for expansion and filtration of oxygen cylinders
Figure 5 Laboratory installation
Figure 6 Laboratory installation
Figure 7 External view of cylinders 1,2, and 3 from company K93
Figure 8 Internal views of cylinder K93.1
Figure 9 Internal views of cylinder K93.2
Figure 10 Internal views of cylinder K93.3
Figure 11 External view of cylinders 1,2, and 3 from company J62
Figure 12 Internal views of cylinders J62.1
Figure 13 Internal views of cylinder J62.2
Figure 14 Internal views of cylinder J62.3
Figure 15 External views of cylinders 1, 2 and 3 from company L89
Figure 16 Internal views of cylinder L89.1
Figure 17 Internal views of cylinder L89.2
Figure 18 Internal views of cylinder L89.3
Figure 19 External view of cylinders 4, 5, and 6 from company K93
Figure 20 Internal views of cylinder K93.4
Figure 21 Internal views of cylinder K93.5
Figure 22 Internal views of cylinder K93.6
Figure 23 External view of cylinders 4, 5, and 6 from company L89
Figure 24 Internal views of cylinder L89.4
Figure 25 Internal views of cylinder L89.5
Figure 26 Internal views of cylinder L89.6

EIGA 2017

Tags: Chemicals EIGA

Articoli correlati

Ultimi archiviati Chemicals

Regolamento UE 2019957
Giu 12, 2019 67

Regolamento (UE) 2019/957

Regolamento (UE) 2019/957 della Commissione dell'11 giugno 2019 recante modifica dell'allegato XVII del regolamento (CE) n. 1907/2006 del Parlamento europeo e del Consiglio concernente la registrazione, la valutazione, l'autorizzazione e la restrizione delle sostanze chimiche (REACH) per quanto… Leggi tutto
Giu 11, 2019 60

Regolamento (CE) n. 710/2009

Regolamento (CE) n. 710/2009 Regolamento (CE) n. 710/2009 della Commissione, del 5 agosto 2009, che modifica il regolamento (CE) n. 889/2008 recante modalità di applicazione del regolamento (CE) n. 834/2007 del Consiglio per quanto riguarda l'introduzione di modalità di applicazione relative alla… Leggi tutto
Giu 10, 2019 40

Decreto 30 luglio 2010

Decreto 30 luglio 2010 Disposizioni per l'attuazione del regolamento (CE) n. 710/2009 che modifica il regolamento (CE) n. 889/2008, recante modalita' di applicazione del regolamento (CE) n. 834/2007 del Consiglio, per quanto riguarda l'introduzione di modalita' di applicazione relativa alla… Leggi tutto
Giu 10, 2019 78

Decreto 3 aprile 2019

Decreto 3 aprile 2019 Modifica del decreto ministeriale 30 luglio 2010, recante disposizioni per l'attuazione del regolamento (CE) n. 710/2009 che modifica il regolamento (CE) n. 889/2008, recante modalita' di applicazione del regolamento (CE) n. 834/2007 del Consiglio per quanto riguarda… Leggi tutto
Decreto 26 marzo 2019
Giu 05, 2019 96

Decreto 26 marzo 2019

Decreto 26 marzo 2019 - Aggiornamento dell'allegato 13 al decreto legislativo 29 aprile 2010, n. 75 recante: «Riordino e revisione delle discipline in materia di fertilizzanti, a norma dell'articolo 13 della legge 7 luglio 2009, n. 88». (19A03517) (GU Serie Generale n.130 del 05-06-2019) -… Leggi tutto
Guidance ECHA draft may2019
Mag 27, 2019 131

Draft Guidance Annex VIII to CLP Vers. 2.0 2019

Guidance on harmonised information relating to emergency health response Annex VIII to CLP Draft version 2.0 - May 2019 This document is the Guidance on the harmonised information relating to emergency health response. It is a comprehensive technical and scientific document on the implementation of… Leggi tutto
EIGA 219 2019
Mag 11, 2019 124

Guideline for Validation of ASU and Cargo Transport Unit

Guideline for Validation of Air Separation Unit and Cargo Transport Unit Filling for Medical Oxygen and Medical Nitrogen EIGA Doc. 219/19 This publication provides the EIGA position and guidance on the manufacturing, bulk product storage, and cargo transport unit (cryogenic tankers and containers)… Leggi tutto

Più letti Chemicals

Mar 02, 2019 17710

Regolamento (CE) n. 2023/2006 (Regolamento GMP)

Regolamento (CE) n. 2023/2006 Regolamento (CE) N. 2023/2006 della Commissione del 22 dicembre 2006 sulle buone pratiche di fabbricazione dei materiali e degli oggetti destinati a venire a contatto con prodotti alimentari (Regolamento GMP - Good Manufacturing Practices) ... Il presente regolamento… Leggi tutto