Slide background
Slide background




Medicinal VIPR Package

ID 8337 | | Visite: 1929 | 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:

Descrizione Livello Dimensione Downloads
Allegato riservato Medicinal VIPR Package.pdf
EIGA Doc. 218/19
357 kB 0

Tags: Chemicals Abbonati Chemicals

Articoli correlati

Ultimi archiviati Chemicals

Regulatory strategy for flame retardants
Mar 15, 2023 66

Regulatory strategy for flame retardants

Regulatory strategy for flame retardants ID 19212 | ECHA 15.03.2023 Aromatic brominated flame retardants, such as polybrominated diphenyl ethers, are generally persistent in the environment. Many, like decabromodiphenylether, are also known or suspected of being toxic and accumulating in people and… Leggi tutto
REACH Authorisation List
Mar 09, 2023 50

REACH Authorisation Decisions List | Last update 09.03.2023

REACH Authorisation Decisions List / Last update: 09.03.2023 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 concerning all applications for… Leggi tutto
Guidance for monomers and polymers
Mar 08, 2023 74

Guidance for monomers and polymers

Guidance for monomers and polymers | ECHA Version 3.0 - February 2023 ID 19176 | 08.03.2023 / In allegato Linee guida ECHA Version 3.0 - February 2023 Polymers are the material of choice in a vast range of applications such as packaging, building and construction, transportation, electrical and… Leggi tutto
Regolamento UE 2023 465
Mar 06, 2023 212

Regolamento (UE) 2023/465

Regolamento (UE) 2023/465 / Tenori massimi di arsenico in alcuni alimenti ID 19148 | 06.03.2023 Regolamento (UE) 2023/465 della Commissione del 3 marzo 2023 recante modifica del regolamento (CE) n. 1881/2006 per quanto riguarda i tenori massimi di arsenico in alcuni alimenti GU L 68/51 del 6.3.2023… Leggi tutto
Mar 02, 2023 135

Regolamento (UE) 2023/447

Regolamento (UE) 2023/447 ID 19100 | 02.03.2023 Regolamento (UE) 2023/447 della Commissione del 1o marzo 2023 che modifica l’allegato II del regolamento (CE) n. 1333/2008 del Parlamento europeo e del Consiglio e l’allegato del regolamento (UE) n. 231/2012 della Commissione per quanto riguarda l’uso… Leggi tutto

Più letti Chemicals

Regolamento  CE  n  178 2002
Ott 24, 2022 77433

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