Isolator Technology Workshop - Live Online

Isolator Technology Workshop - Live Online

Seminar Nr. 19206

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

Note: All times mentioned are CET.

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

Sprecher

Dr Patricia Desmaris, Merck Group
Christian Doriath, SKAN
Theresa Ladwig, SKAN
Johannes Oberdörfer, Boehringer Ingelheim Pharma
Benoît Ramond, Sanofi
Ruben Rizzo, SKAN
Katharina Schlereth, Labor LS
Yves Scholler, SKAN

Zielsetzung

Why should you attend this Live Online Training?
  • You get an technological update on isolators for aseptic manufacture
  • 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 in the manufacturing of sterile medicinal products, particularly in aseptic manufacture, and in the handling of toxic / high potent APIs. 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“ and the expected revision of EU GMP Annex 1.

Zielgruppe

This ECA Live Online Training addresses those employees from the pharmaceutical industry and from suppliers / Contract organisations  involved in the engineering, validation and operation of  Aseptic (toxic) Manufacturing Isolators, 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.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://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 email 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.

Programm

Regulatory Requirements for Isolators for Aseptic Use
  • Regulatory bodies
  • US laws and regulations
  • European laws and regulations
  • Guidelines
  • Basic Isolator definitions
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
A virtual factory tour at SKAN shows you actual isolators in different stages of the manufacturing process
 
Case Study Merck: New Aseptic Filling Building:
A Quality by Design Approach
  • Presentation of the project
  • Business case construction
  • Compliance requirements
  • QBD approach and implementation
  • Product Tech Transfer strategy
  • ASTME2500 qualification and validation strategy
Annex 1 - Risk Analysis and Consideration of Transfer Material and Environmental Monitoring
  • Contamination Control Strategy & Quality Risk
  • Management Principles
  • Environmental monitoring program
  • Gloves/Sleeves management program
  • Transfer materials & personnel interventions
  • Aseptic processing validation management
 
Workshop:
Qualification 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
 
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
  • 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
Workshop: 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
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)
Case Study / Workshop: Troubleshooting at Customer Site
  • Description of the situation
  • What kind of investigation is expected?
  • Corrective Action Preventive Action (CAPA)
A Look into Rapid Microbial Contamination Detection in Cell containing Samples
  • Current challenges of conventional methodologies
  • Beta Testing of Celsis Adapt™ system at Boehringer Ingelheim and Labor LS
  • Technology features and perspectives for the pharmaceutical industry

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