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.
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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

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