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ECA - Modern Sterile Operations

100% Control of Parenterals (9. April 2019)

Objectives

You will get an overview on GMP- & compendial requirements for the testing of sterile pharmaceutical products concerning container-/Closure-Integrity testing and inspection of particles: what is state-of-the-art in the pharmaceutical industry is and which technologies are available.

Background

The 100% visual inspection of parenteral medicines, irrespective of the container type, is a requirement of the harmacopeias. The inspection can be done manually or automatically – the latter being increasingly used. This is different for the testing of the integrity of the container/closure system. Here a 100% testing is only officially required for Containers closed by fusion, e.g. ampoules. But, as the risk of unsterile Containers due to cracks or leakages is high for the patient, some pharmaceutical companies also increasingly test the whole batch for integrity. This 100% testing is done with automated systems with different techniques, dependent on the type of container.

In this conference we will discuss:

  • What are the authorities' actual/future requirements?
  • Which primarily automated testing techniques are available?
  • What will change due to the revision of EU Annex 1?
  • What are the requirements for DI for the automated testing systems?

Moderator

Jörg Zimmermann, Vetter Pharma Fertigung

Target Audience

This conference is directed at specialists from the areas engineering, production and QA dealing with the implementation and operation of automated systems for the CCI testing or visual inspection of sterile medicinal products.

Programme

CONGRESS KEYNOTE
Pharmaceutical industry in digital change

Thomas Reiner, CEO, Berndt+Partner

  • Changes in the value chains
  • Opportunities and risks for production processes
  • What can and will change for packaging?
  • Strategies to benefit from Change

 

Pharmacopeial- and GMP-requirements for visual Inspection
Dr. Daniel Müller, GMP Inspectorate Baden-Württemberg

  • Manual inspection (training, working place, qualification)
  • Automated inspection (system validation and re-validation)
  • Test sets (usage, storage, quality aspects)
  • AQL testing as part of batch release
  • Handling of rejects and ejects

Pharmacopeial- and GMP-requirements for Container-/Closure-Integrity testing
Dr. Daniel Müller, GMP Inspectorate Baden-Württemberg

  • Test of ampules
  • Test of vials and syringes, 100% vs sampling
  • Test methods: blue dye test and others
  • Inspection findings

Data Integrity & Audit Trail Review for Visual Inspection Systems
Felix Krumbein, Roche Diagnostics

  • General regulatory requirements regarding data integrity
  • Complete, consistent, and accurate data in the context of Visual Inspection Systems
  • Data integrity starts with a proper user access management
  • Batch-wise modification of product-related configuration parameters
  • Audit Trail Review concepts

Case Study Rommelag CMO – 100% inline CCI Testing and particle inspection of BFS ampoules
Dr. Martin Haerer, Rommelag
Dr. Matthias Kahl, Wilco

  • Project overview
  • Technical & regulatory requirements
  • Machine concept
  • Sample preparation
  • Qualification and Validation
  • Operation of the inspection System

Pharmaceutical Case Study
TBD

Live Demos

In the practical part of the conference, suppliers will show you different components and solutions. You will come in contact with the equipment and you have the chance to discuss your questions immediately with technology experts.

Head Space Analysis for difficult to inspect Containers
Wilco

Container-/Closure Integrity Testing with Nitrogen
Lippok & Wolf

TBD
Heuft

 

Sterile Filtration (10. April 2019)

Objectives

  • You will be informed on new regulatory and technological developments in sterile Filtration
  • You learn the influence of the Annex 1 revision to sterile filtration and how to interpret the requirements to PUPSIT (Pre Use Post Sterilisation Integrity Test)
  • You will get case studies from pharmaceutical companies
  • Live Demos will show you how technologies perform

Background

Sterile Filtration is especially in the aseptic manufacture of medicinal products still the sterilisation method no 1 choice. The first draft of the Annex 1 revision defines comprehensive requirements wirh regard to the sterilisation. In light of these requirements the conference focuses on their practical implementation in pharmaceutical operations- and will also cover the controversially discussed question on pre-use post Sterilisation integrity test.

Moderator

Jörg Zimmermann, Vetter Pharma Fertigung

Target Audience

The event is directed at specialists from the pharmaceutical industry as well as from suppliers who have to deal with sterile filtration Technologies in clean in their daily practice.

Programme

CONGRESS KEYNOTE
EU GMP Inspection in Sterile/Aseptic Production
Klaus Eichmüller, Wolnzach, c/o Regional Council Darmstadt, GMP Inspectorate, Germany
Head of Inspectorate

  • Main focus areas of inspections
  • Frequently detected findings
  • Data Integrity issues – where are possible weak spots?
  • Possible new areas due to the revision of Annex 1 and further regulatory changes

 

Sterile Filtration - GMP inspector's view
Dr. Daniel Müller, GMP Inspectorate Baden-Württemberg

  • Sterilisation methods & sterile Filtration
  • Reguatory documents on sterile Filtration
  • Draft Annex 1: requirements for sterile filtration process
  • State of the art equipment & processing
  • Experience from GMP inspections

Live Demos

In the practical part of the conference, suppliers will show you different components and solutions. You will come in contact with the equipment and you have the chance to discuss your questions immediately with technology experts.

Adoption of a Single-Use Sterile Filtration Assembly
Merck Chemicals

Sterilizing-grade Filtration in Biopharmaceutical Applications
Pall Life Science

Case study: Inline-Filtration using peristaltic pump: Implementation of a pressure control
Doris Rottenbusch, Vetter Pharma-Fertigung

  • Initial request from FDA
  • Technical concept phase: market research and laboratory studies
  • Implementation of a prototype set-up on a filling line
  • Practical experience
  • Outlook

Sterile filtration – microbiological filter valdiation
Matthias Schaar, Novartis Pharma

  • Requirements
  • Initiating a scale down study
  • How is the correlation to filter integrity testing