Isolator Technology Workshop Engineering – Validation - Operation

Isolator Technology Workshop

Basel, Switzerland

Seminar Nr. 20070

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

 

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

Sprecher

Theresa Ladwig, SKAN, Switzerland
Julia Pauly, GP Grenzach Produktion, Germany
Benoît Ramond, Microbiologic Expert (formerly Sanofi, France)
Ruben Rizzo, SKAN, Switzerland
Katharina Schlereth, Labor LS, Germany
Yves Scholler, SKAN, Switzerland
Claudia Wegmann, Cilag, Switzerland

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 takes 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 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
  • 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
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
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
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)
Isolator Technology and Challenges in Sterility Testing
 
Isolators Used in Aseptic Fill Finish Manufacturing
  • Isolator technologies in a parenteral production
  • Preparation of an isolator used for aseptic filling
  • Implementation of a new isolator
    • Design / Mock-up / From qualification to validation
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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