Isolator Technology Workhops

27-28 October 2015

Basel, Switzerland

Seminar Nr. 9273

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Kosten

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

Sprecher

Christian Doriath
Skan
Philippe Jerome
Skan
Theresa Ladwig
Skan
Yves Scholler
Skan
Patrick Vanhecke
GSK Biologicals
Christian Vogt
Novartis

Zielsetzung

Why should you attend this event?
You get an update on isolators for aseptic manufacture and for sterility testing
You get to know the results of recent studies on the validation of isolators
You have the opportunity to discuss your individual questions personally with experts
You can translate the theory directly into practice during 3 workshops at the manufacturing site of Skan in Allschwil

Each participant will take part in all 3 workshops.
The workshops are held at the plant of Skan AG, partly including operational isolators. This brings the participants as close to daily practice as possible.

Hintergrund

The use of isolators is increasing both in sterility testing and in the production of sterile medicinal products, particularly in aseptic manufacture. It ensures a greater microbiological safety of the products, but at the same time requires increased inputs as regards the qualification of these systems and the validation of the production processes.

In 2004, Appendix 1 to the FDA Guidance for Industry “Sterile Drug Products Produced by Aseptic Processing” defined new regulatory requirements on using this technology, as did the PIC/S document PI 014-3 “Isolators used for Aseptic Processing and Sterility Testing“.

Zielgruppe

This GMP Education Course addresses those employees from the pharmaceutical industry and from suppliers of isolators for aseptic (toxic) manufacture and for sterility testing involved in the engineering, validation and operation of these systems, especially from the areas
Engineering / Production
Quality Assurance
Qualification/ Validation
Microbiology

The number of participants is limited.
Please understand that, for competitive reasons, not all firms can register their employees for this event.

Workshops at Skan AG

Each participant will take part in all 3 workshops.
The workshops are held at the plant of Skan AG, partly including operational isolators. This brings the participants as close to daily practice as possible.

Programm

Regulatory Requirements for Isolators for Aseptic Use
Regulatory bodies
US laws and regulations
European laws and regulations
Guidelines
Yves Scholler

Filling Isolator Projects: From the Conceptual Design
to the Validated Equipment (Supplier)
Key decisions
What do we need from our customers?
From URS to engineering – technical details and solutions
Process challenges and features
FAT – Installation – Qualification
Philippe Jerome

Filling Isolator Projects: Mock-up study
Purpose of mock-up
What is required before starting a mock-up
How to document a mock-up
What simulations need to be included in the mock-up
Execution of the mock-up itself
Examples for our mock-up to underline the points above
Philippe Jerome

Isolator Technology: From the Conceptual Design to the Validated Equipment
Isolator technology in GSK Bio
Isolator and associated development
Conceptual design for a new process under isolator
Validation challenges
Manufacturing advantages
Patrick Vanhecke

Isolators used for Sterility Testing
Requirements for the isolator
Background of the isolator
Performance Qualification
Qualification of operators
Test for gas-tightness of primary packaging materials
Handling in isolator
Movie
Capacity
Testing the tightness of gloves
Microbiological Monitoring
Sample plan
Contamination level
Contamination source
OOS/CAPA (example)
N.N.

Bioindicators
Process Development of Isolator Decontamination
Overview of current regulations and standards
Basis and selection of suitable biological indicators as sensor for the inactivation effect
Development and quantification of decontamination cycles
Influence of H2O2 to routine processes
Theresa Ladwig

Troubleshooting in isolator technology while understanding
The place of the isolator in a pharmaceutical process
The influence of critical parameters on the decontamination process
The reliability and reproducibility of biological indicators
The expectations of regulators
Christian Doriath

Microbiology in Filling and Sterility Isolators
Environmental monitoring
Media Fills
Sterility tests
Integrity of gloves and sleeves
Validation studies
OOS results in isolators
Dr Christian Vogt

Workshop Session

Workshop 1:
Validation Planning for an Aseptic Isolator
Test master plan (IQ/OQ)
IQ / OQ test protocols
Operational qualification - procedures
Handling of deviations

Performance of Selected Qualification Tests
Basic SOP for testing
Execution of tests
Generate test records
Drawing up the test report
Glove testing

Glove integrity testing
Regulatory Background
Physical methods for glove integrity tests and their boundaries
Microbiological contamination risk
Routine program for glove integrity testing
Yves Scholler / Philippe Jerome

Workshop 2:
Development and Quantification of H2O2
Decontamination Cycles
Establish the requirements of a decontamination cycle
Design a qualification strategy
Work out the necessary physical and microbiological tests and their chronology
Interpretation of test results and reaction on deviations
Write a transparent qualification report
Workshop including a real isolator system
Theresa Ladwig

Workshop 3:
Isolators in Routine
Handling in isolators
Personnel at isolators
RTP system
Environmental monitoring in isolators
Frequency of decontaminations
Problems in isolators from the point of view of a user
Dr Christian Doriath

You will take part in all workshops!

The workshops will take place at SKAN AG in Allschwil. After the workshops at appr. 16.30 h, a bus shuttle service will bring the participants to the airport, the train station or the hotel.

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