Container/Closure Integrity Testing
Im Auftrag der ECA Academy

10 October 2017

Vienna, Austria

Seminar Nr. 16050

Unser Seminarservice

Kosten

Die Veranstaltung hat bereits stattgefunden

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Christoph Herdlitschka, Wilco

Dr Roman Mathaes, Lonza

Olivier Métraux, F. Hoffmann - La Roche

Dr Tobias Posset, Roche

Dr Heino Prinz, Rommelag AG

Dr Bernd Renger, Immediate Past Chair of the European QP Association

Zielsetzung

Different products and different container types require different testing methods: this event aims at giving an overview of the different CCI testing systems which are applied during production and as part of the quality control system. Apart from technical aspects the regulatory requirements on CCI testing will be highlighted as well as the applicability of inline and offline testing.

Hintergrund

An intact container closure system, which is the sum of packaging components that protect the dosage form, is the pre-requisite for a safe and sterile drug product. The CC system protects the product from microbial contamination and also from exposure to gases or water vapor or the loss of solvent. Container Closure integrity testing is therefore a regulatory requirement and it is part of the whole life cycle of a sterile drug product.

Initially this testing was performed as part of the initial development of the packaging system and the system’s suitability verified in stability studies including on-going stability. Over the years, the expectation was raised to perform batch by batch verification with latest trends to 100 % inline or offline testing wherever possible.

We will discuss and answer questions like:

What are the current and upcoming GMP and compendial requirements?
Will container closure integrity testing change to 100% inline testing?
Modern blue dye testing
Which testing technologies are available and suitable?
CCI testing of prefilled syringes
CCI testing of lyo & liquid vials
CCI testing of ampoules

Zielgruppe

This conference is directed at specialists and executives from the areas engineering and production and QA dealing with the implementation and operation of systems for the container/closure-integrity testing of sterile medicinal products.

Programm

Container Closure Integrity testing of sterile drug products – requirements, expectations and exaggerations

Container Closure Integrity during Development, Qualification and Stability Testing
Regulatory, Pharmacopoeial and GMP requirements
System integrity versus container damages
Patient risks – do we need batch by batch testing?
Industrial best practices

Overview of container/closure integrity testing technologies
The presentation gives a comprehensive overview about current CCI technologies and techniques. It focuses in the first part on physical fundamentals of the different testing methods

Pressure / Vacuum Decay
LFC (Liquid Filled Container) leak testing
TDLAS/ HSA (frequency modulated spectroscopy)
High Voltage leak testing
3µm IR and Mass-Spectroscopy
Force Detection

In the second part criteria or a selection matrix for test methods related to the product requirements and properties including primary container type, product properties (liquid, lyo, etc.) is presented. The main topics here are as follows.

Inline versus sample testing
Limits and false acceptance traps
Leak sizes and leak rates (false friends and measurable properties?)

Modern Blue Dye Testing – still the standard CCI method?

Regulatory requirements and subsequent test method in industry
Critical method aspects, e.g. process monitoring
Perspective and limits in context of product life cycle

Integrity testing of Prefilled Syringes

Sampling plan
He-leak testing
Limitations of the He-leakage test
Cross Validation with mCCI

100 % inline CCI testing of ampoules

High Voltage inline testing: method description
Integration in the production process
Limits of the system
Qualification of the system
Validation
Routine Operation

Case Study: 100 % inline testing of Lyo Vials

System setup
Validation
Routine operation

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Container/Closure Integrity TestingIm Auftrag der ECA Academy