Control of Parenterals - Container/Closure Integrity Testing - Live Online

Control of Parenterals - Container/Closure Integrity Testing - Live Online

Course No 17952

This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager". Learn more.

All times mentioned are CET.

Costs

This training/webinar cannot be booked. To find alternative dates for this training/webinar or similar events please see the events list by topic.

For many training courses and webinars, there are also recordings you can order and watch any time. You can find these recordings in a list sorted by topic.

Or simply send us your inquiry by using the following contact form.

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Martin Becker, IDT Biologika
Roland Koch, Gasporox
Felix Krumbein, Roche
Christof Langer, OSConsulting
Dr Daniel Müller, GMP-Inspector

Objectives

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.

Background

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 vapour 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 in the US / EU / RoW?
  • Will container closure integrity testing change to 100% inline testing?
  • What does the Annex 1 require?
  • How do we have to define’ tight’?
  • Which testing technologies are available and suitable?
  • CCI testing of lyo & liquid vials
  • CCI testing of ampoules

Target Group

This course 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.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and e-mail address for the test. If the Installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

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
Container Closure Integrity Testing of Parenterals – a GMP inspector‘s View
  • Applicable regulations & guidance
  • Implementation of current requirements
  • Expectations of a GMP-Inspector in GMP Inspections
  • Examples of observations
Overview of Container/Closure Integrity Testing Technologies
The presentation gives a complete overview of the different aspects of leak testing to do CCIT in the pharmaceutical production. The systems presented can be used for the CCIT of vials, ampoules, syringes, BFS, IV bags, blisters etc.
  • Leak, leak rate and the relevant physical units
  • Leak test methods
    • Pressure change methods (vacuum, pressure and LFC)
    • Head Space Analysis using TDLAS
    • Helium Leak Test and other Mass Spectroscopy Systems
    • High Voltage Leak Detection (HVLD)
    • Force Sensing Technology
  • Capabilities and examples of the different methods
  • How to select the right method
  • How to generate positive controls
Case Study: 100% Testing of Vials
  • System Setup
  • Validation
  • Routine operation
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
 

Go back

GMP Conferences by Topics