Slide background
Slide background




Quality of delivered product from medicinal gas cylinders

ID 4072 | | Visite: 2633 | 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

Ott 19, 2020 10

Direttiva 76/769/CEE

Direttiva 76/769/CEE Direttiva 76/769/CEE del Consiglio, del 27 luglio 1976, concernente il ravvicinamento delle disposizioni legislative, regolamentari ed amministrative degli Stati Membri relative alle restrizioni in materia di immissione sul mercato e di uso di talune sostanze e preparati… Leggi tutto
Ott 19, 2020 10

Direttiva 2002/62/CE

Direttiva 2002/62/CE Direttiva 2002/62/CE della Commissione, del 9 luglio 2002, che adegua al progresso tecnico per la nona volta l'allegato I alla direttiva 76/769/CEE del Consiglio concernente il ravvicinamento delle disposizioni legislative, regolamentari ed amministrative degli Stati membri… Leggi tutto
EU chemical strategy
Ott 14, 2020 36

EU Chemicals Strategy for Sustainability

EU Chemicals Strategy for Sustainability 14.10.2020 - Chemicals Strategy for Sustainability Towards a Toxic-Free Environment La Commissione europea ha pubblicato una strategia per la sostenibilità delle sostanze chimiche il 14 ottobre 2020. Fa parte del progetto inquinamento zero dell'UE, che è un… Leggi tutto
IARC monograpsh 100C
Ott 03, 2020 180

IARC monographs 100C

IARC monograpsh 100C Arsenic, metals, fibres, and dusts Soon after IARC was established in 1965, it received frequent requests for advice on the carcinogenic risk of chemicals, including requests for lists of known and suspected human carcinogens. It was clear that it would not be a simple task to… Leggi tutto
EIGA 233 20
Set 30, 2020 79

Emergency response planning

Emergency Response Planning Doc. EIGA 233/20 Companies are required to take reasonable measures to prevent emergency situations such as fires or leaks from happening, but emergencies are still possible on any site. Every site should therefore have an emergency plan and the necessary resources in… Leggi tutto
Set 25, 2020 60

DPCM 25 febbraio 2005

Decreto del Presidente del Consiglio dei Ministri del 25 febbraio 2005 Linee guida per la predisposizione del piano d'emergenza esterna di cui all´art. 20, comma 4, del decreto legislativo 17 agosto 1999 n. 334 (G.U. n. 61 del 16 marzo 2005 SO n. 40) Collegati[box-note]Seveso: timeline… Leggi tutto

Più letti Chemicals

Regolamento  CE  n  178 2002
Feb 28, 2020 36045

Regolamento (CE) N. 178/2002

Regolamento (CE) n. 178/2002 Regolamento (CE) n. 178/2002 del Parlamento europeo e del Consiglio del 28 gennaio 2002 che stabilisce i principi e i requisiti generali della legislazione alimentare, istituisce l'Autorità europea per la sicurezza alimentare e fissa procedure nel campo della sicurezza… Leggi tutto
Regolamento  CE  852 2004
Mar 06, 2019 29713

Regolamento (CE) N. 852/2004

Regolamento (CE) N. 852/2004 Regolamento (CE) N. 852/2004 del Parlamento europeo e del Consiglio del 29 aprile 2004 sull'igiene dei prodotti alimentari GU L 139/1 del 30.4.2004 Testo consolidato 2009Modificato da: Regolamento (CE) n. 1019/2008 della Commissione del 17 ottobre 2008 (GU L 277 7… Leggi tutto