Slide background
Slide background




Quality of delivered product from medicinal gas cylinders

ID 4072 | | Visite: 5234 | Documenti Chemicals EntiPermalink: https://www.certifico.com/id/4072

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

DescrizioneLinguaDimensioneDownloads
Scarica questo file (Quality of delivered product from medicinal gas cylinders.pdf)Quality of delivered product from medicinal gas cylinders
EIGA 2017
EN1298 kB1303

Tags: Chemicals EIGA

Articoli correlati

Ultimi archiviati Chemicals

Mar 20, 2025 652

Regolamento delegato (UE) 2020/1413

Regolamento delegato (UE) 2020/1413 ID 23662 | 20.03.2025 Regolamento delegato (UE) 2020/1413 della Commissione del 29 giugno 2020 che rettifica la versione in lingua svedese dell’allegato I del regolamento (CE) n. 1272/2008 del Parlamento europeo e del Consiglio relativo alla classificazione,… Leggi tutto
IARC Monograph Volume 58
Mar 17, 2025 769

IARC Monographs Volume 58 / 1993

IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 58 / IARC 1993 ID 23643 | 17.03.2025 / Attached Beryllium, Cadmium, Mercury, and Exposures in the Glass Manufacturing Industry Evaluates the carcinogenic risk to humans posed by exposure to selected metals and their compounds.… Leggi tutto
Mar 14, 2025 944

Regolamento (UE) 2024/2929

Regolamento (UE) 2024/2929 ID 23634 | 14.03.2025 Regolamento (UE) 2024/2929 della Commissione, del 27 novembre 2024, che rettifica la versione in lingua francese dell’allegato XVII del regolamento (CE) n. 1907/2006 del Parlamento europeo e del Consiglio per quanto riguarda i livelli di… Leggi tutto
Microbioma nell uomo negli animali negli alimenti e nell ambiente
Mar 14, 2025 756

Microbioma nell’uomo, negli animali, negli alimenti e nell’ambiente

Microbioma nell’uomo, negli animali, negli alimenti e nell’ambiente / Rapporto ISTISAN 2025 ID 23627 | 14.03.2025 / In allegato (EN) Microbioma nell’uomo, negli animali, negli alimenti e nell’ambiente: implicazioni per la valutazione del rischio nella sicurezza alimentare. L’Autorità Europea per la… Leggi tutto
Rapporto sui controlli ufficiali nel settore dell alimentazione animale eseguiti 2023
Mar 05, 2025 696

Rapporto sui controlli ufficiali nel settore dell’alimentazione animale 2023

Rapporto sui controlli ufficiali nel settore dell’alimentazione animale eseguiti nel 2023 ID 23563 | 05.03.2025 / In allegato Il presente rapporto si propone di rendere pubblici gli esiti dei controlli ufficiali effettuati nel 2023, ultimo anno di applicazione del Piano Nazionale di controllo… Leggi tutto
Mar 05, 2025 767

Regolamento (CE) n. 1451/2007

Regolamento (CE) n. 1451/2007 Regolamento (CE) n. 1451/2007 della Commissione, del 4 dicembre 2007 , concernente la seconda fase del programma di lavoro decennale di cui all’articolo 16, paragrafo 2, della direttiva 98/8/CE del Parlamento europeo e del Consiglio relativa all’immissione sul mercato… Leggi tutto
Mar 05, 2025 788

Regolamento delegato (UE) 2025/452

Regolamento delegato (UE) 2025/452 ID 23560 | 05.03.2025 Regolamento delegato (UE) 2025/452 della Commissione, del 19 dicembre 2024, recante rettifica del regolamento delegato (UE) 2021/642 della Commissione che modifica l’allegato III del regolamento (UE) 2018/848 del Parlamento europeo e del… Leggi tutto
REACH Authorisation List
Mar 04, 2025 738

REACH Authorisation Decisions List / Last update: 04.03.2025

REACH Authorisation Decisions List / Last update: 04.03.2025 ID 23559 | Last update: 04.03.2025 REACH Authorisation Decisions List of authorisation decisions adopted on the basis of Article 64 of Regulation (EC) No 1907/2006 (REACH). The list also includes reference to related documentation… Leggi tutto

Più letti Chemicals

Notifica HACCP
Apr 05, 2022 96980

Notifica ai fini registrazione Regolamento CE n. 852/2004

Notifica ai fini della registrazione (Reg. CE n. 852/2004) - Ex notifica sanitaria alimentare ID 7901 | 06.03.2019 / Modello notifica allegato [panel]Regolamento (CE) 852/2004...Articolo 6 Controlli ufficiali, registrazione e riconoscimento 1. Gli operatori del settore alimentare collaborano con le… Leggi tutto