Isolator Technology Workshop
Im Auftrag der ECA Academy

26/27 November 2019

Basel, Switzerland

Seminar Nr. 16750

Unser Seminarservice

Kosten

Die Veranstaltung hat bereits stattgefunden. Suchen Sie nach Wiederholungsterminen und weiteren, themenbezogenen Seminaren auf der Seite GMP Seminare/-Konferenzen nach Thema.

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

Sprecher

Christian Doriath, SKAN
Theresa Ladwig, SKAN
Benoît Ramond, Sanofi SA, France
Ruben Rizzo, SKAN
Katharina Schlereth, Labor L+S
Yves Scholler, SKAN
Patrick Vanhecke, GSK Vaccines
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

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 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

Programm

Regulatory Requirements for Isolators for Aseptic Use

Regulatory bodies
US laws and regulations
European laws and regulations
Guidelines

Isolator and associated technologies

Isolator technology in GSK Bio
Applications for bulk
Applications for formulation
Applications for filling processes
Sterility testing

Isolator Application / Projects: From the Conceptual Design to the Validated Equipment incl. Mock-Up Study

Key decisions
What do we need from our customers?
From URS to engineering – technical details and solutions
Process challenges and features
FAT – Installation – Qualification
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

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
- Capacity
- Testing the tightness of gloves
Microbiological Monitoring
- Sample plan
- Contamination level
- Contamination source
- OOS/CAPA (example)

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

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

Microbiology in Filling and Sterility Isolators

Environmental monitoring
Media Fills
Sterility tests
Integrity of gloves and sleeves
Validation studies
OOS results in Isolators

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

Workshop 2: Development and Quantification of H₂O 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

Workshop 3: Isolators according EU Annex 1

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

You will take part in all workshops!

The workshops will take place at SKAN AG in Allschwil. After the workshops at appr. 16.15 h, a bus shuttle service will bring the participants to the airport (appr. 16.35 h), the German train station (appr. 16.50 h), the Swiss train station (appr. 17.15 h) or the hotel.

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Isolator Technology WorkshopIm Auftrag der ECA Academy