Isolator Technology Workshop - Sterility Test Isolator
Im Auftrag der ECA Academy

Isolator Technology Workshop - Sterility Test Isolator Im Auftrag der ECA Academy

Basel, Switzerland

Seminar Nr. 17454


Kosten

HABEN SIE INTERESSE AN DEM SEMINAR?

Bitte kontaktieren Sie uns und wir informieren Sie:

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

Sprecher

Dr Michael Daferner, BAYER
Christian Doriath, SKAN
Theresa Ladwig, SKAN
Elodie Muller, Novartis Pharma
Alain Ribstein, SKAN
Katharina Schlereth, Labor L+S AG
Yves Scholler, SKAN

Zielsetzung

Why should you attend this event?
  •  You get an update on isolators 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 consequences of a failed sterility test are enormous. The use of Sterility Test Isolators offers a much safer way to avoid false positive results. That’s why the use of isolators for sterility testing has become a standard in the pharmaceutical industry and in microbiological contract laboratories. But at the same time Isolator Technology requires an increased input with regard to the qualification of these systems and the validation of the decontamination process.

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 GMP Education Course addresses those employees from the pharmaceutical industry and from suppliers / contract organisations involved in the engineering, validation and operation of Sterility Test Isolators, especially from the areas
  •  Engineering
  •  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.

Programm

Regulatory Requirements for Sterility Test Isolators
  •  Regulatory bodies
  •  US laws and regulations
  •  European laws and regulations
  •  Guidelines
  •  Basic Isolator definitions
Sterility Test Isolators: Standard Process under Control 
  •  Key decisions: sterility testing in isolator vs. cleanroom
  •  Cost comparison
  •  From URS to isolator
  •  Technical details and solutions
  •  Airflow and decontamination system
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
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)
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
Gone with the Wind – How Are we Doing with a SkanFog® Sterility Test Isolator?
  •  From clean room to isolators
  •  Why SkanFog® for sterility test isolators?
  •  Our 3 isolators and a bit technology
  •  Performance Qualification
  •  The new lab building @ Bayer Berlin
  •  Double challenge: New lab building and new technology
  •  Lessons learned
Alternative Sterility Testing Methods: Experience Feedback and Outlook
  •  Experience feedback regarding alternative method
  •  Outlook
  •  Challenges
  •  Impact on Sterility Test Isolators
Workshop Session
Workshop 1: 
Validation Planning for an Sterility Test  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
Alain Ribstein

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:
Sterility Test Isolators in Routine
  •  Handling in isolators
  •  Personnel at isolators
  •  RTP / airlock system
  •  Parametric release
  •  Frequency of decontaminations
  •  Point of view of a user
  •  Point of view of regulatory
Christian Doriath

You will take part in all workshops!
The workshops will take place at SKAN AG in Allschwil.

After the workshops, at appr. 16.15 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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