Slide background
Slide background




Medicinal VIPR Package

ID 8337 | | Visite: 1119 | Documenti Chemicals EntiPermalink: https://www.certifico.com/id/8337

218 19

Medicinal VIPR Package - Lifetime Performance of Drug Delivery Device

EIGA Doc. 218/19

One of the major developments on how medicinal gases are delivered to patients has been the introduction of cylinders fitted with valves that have an integrated pressure regulator.

These medical gas cylinder packages fitted with a valve with integrated pressure regulators (VIPRs) offer a number of significant benefits to both the healthcare professional and the homecare patient when administering the medicinal gas for clinical treatment.

The medical VIPR packages have now been in service for more than twenty years and they have proven to be both reliable and beneficial to those administering medicinal gas from cylinders. Although the medical VIPR packages are used predominantly in medical oxygen service, they can be used for other gases and gas mixtures, including medical air and nitrous oxide/oxygen analgesic gas mixtures.

Although the intended performance of the medical gas VIPR (when initially put into service) is specified in the valve manufacturer’s technical file, the pharmaceutical legislation also requires the gas manufacturer to ensure that the valve is performing correctly each time the cylinder is filled and supplied for patient use over its complete service life. It is important that the VIPR will control the gas supply accurately, as both over and under administration of the gas can lead to patient harm. By establishing a process of valve performance verification and by trending any report received from the customer, it is possible to provide the appropriate assurances that the medical VIPR will function correctly.

This publication is a guideline that describes the basic requirements for the tests that the VIPR manufacturer should perform and the performance checks carried out by the gas manufacturer. This will assist to ensure that the VIPR performs as intended throughout its service life.

This publication applies to filled medicinal VIPR packages used to administer medicinal gases by healthcare professionals and homecare patients.
_________

Table of Contents
Introduction
Scope and purpose
2.1 Scope
2.2 Purpose
Definitions
3.1 Publication terminology
3.2 Technical definitions
Intended performance of medicinal VIPRs
Test requirement for VIPR manufacturers
5.1 General
5.2 Cleaning
5.3 Test conditions for additional tests
5.4 Additional tests to be performed on every medicinal VIPR
Requirements for gas manufacturers
6.1 Initial qualification of a model of VIPR
6.2 Incoming inspection
6.3 VIPR fitting
6.4 First fill
6.5 Post-maintenance fill
Medical VIPR package refilling 
7.1 Pre-fill testing 
7.2 Tests and inspection after filling 
Management of rejected VIPRs at gas manufacturer
Reporting to health authorities 
References 
Other references 
Appendix 1 – Typical Risk Assessment
Appendix 2 - Technical part on medicinal VIPR
Appendix 3 - Flow delivery to the patient
Appendix 4 – Regulatory background

Fonte: EIGA

Collegati:



Tags: Chemicals Abbonati Chemicals

Articoli correlati

Ultimi archiviati Chemicals

Cattura
Apr 22, 2021 15

III Rapporto ECHA sulla strategia di regolamentazione integrata 2020

III Rapporto ECHA sulla strategia di regolamentazione integrata Integrated Regulatory Strategy Annual Report Helsinki, 21 aprile 2021 Il terzo rapporto dell'ECHA sulla strategia di regolamentazione integrata fornisce le ultime novità sul lavoro dell'Agenzia per identificare e gestire le sostanze… Leggi tutto
Apr 16, 2021 72

Seconda relazione consuntiva CE: furani e i bifenili policlorurati - 2007

Seconda relazione consuntiva CE: furani e i bifenili policlorurati - 2007 Comunicazione della Commissione al Consiglio, al Parlamento Europeo e al Comitato economico e sociale europeo relativa all’attuazione della strategia comunitaria sulle diossine, i furani e i bifenili policlorurati (COM(2001)… Leggi tutto
Decisione UE 2021 592
Apr 13, 2021 47

Decisione (UE) 2021/592 del Consiglio del 7 aprile 2021

Decisione (UE) 2021/592 del Consiglio del 7 aprile 2021 relativa alla presentazione, a nome dell’Unione europea, di una proposta di inclusione del clorpirifos nell’allegato A della convenzione di Stoccolma sugli inquinanti organici persistenti GU L 125/52 del 13.04.2021 Entrata in vigore:… Leggi tutto
Report EFSA 2019 Pesticide
Apr 12, 2021 66

Reports EFSA on pesticide residue analysis performed in 2019

Reports EFSA on pesticide residue analysis performed in 2019 EFSA, 07 Aprile 2021 Pubblicato l’ultimo rapporto sui residui di pesticidi negli alimenti nell’Unione europea, uno spaccato dei tenori di residui riscontrati nell’intero territorio in un paniere di prodotti di largo consumo. Nel 2019 sono… Leggi tutto
Apr 09, 2021 98

Protocollo inquinanti organici persistenti della convenzione del 1979

Protocollo sugli inquinanti organici persistenti della convenzione del 1979 sull'inquinamento atmosferico transfrontaliero a grande distanza (GU L 81, 19.3.2004) Collegati
La Convenzione di Stoccolma: Inquinanti organici persistentiRegolamento (UE) 2019/1021 (POPs) | Consolidato
Leggi tutto
Apr 09, 2021 113

Comunicazione 2001/C 322/02

Comunicazione 2001/C 322/02 Comunicazione della Commissione al Consiglio, al Parlamento europeo e al Comitato economico e sociale - Strategia comunitaria sulle diossine, i furani e i bifenili policlorurati 2001/C 322/02 (COM/2001/0593 definitivo) (GU n. 322 del 17.11.2001) Leggi tutto

Più letti Chemicals

Regolamento  CE  n  178 2002
Feb 28, 2020 43794

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