Isolator Technology Workshop - Engineering, Validation, Operation

Isolator Technology Workshop - Engineering, Validation, Operation

Basel, Switzerland

Course No 16750


Costs

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

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

Objectives

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

Background

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“.

Target Group

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

Programme

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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