GMP Certification Programme

Certified Sterile Production Manager

Speakers

Dr Michael Daferner
Isolator Technology Workshop –
BAYER
Sterility Test Isolator
Christian Doriath
SKAN Engineering – Validation - Operation
3/4 June 2020, Basel | Switzerland
Patrick Graser
SKAN

Theresa Ladwig
SKAN

Elodie Muller
Novartis Pharma

Alain Ribstein
SKAN

Katharina Schlereth
Labor L+S AG

Yves Scholler
SKAN Image: Skan AG

Highlights
ƒ Key Decision: Sterility Testing in Isolator vs. Cleanroom
ƒ Process Development of Isolator Decontamination
ƒ Bioindicators
ƒ Troubleshooting in Isolator Technology
ƒ Glove Integrity Testing
ƒ Customer Benefit for Standardized Software
ƒ Case Studies from
- Bayer
- Labor L+S
- Novartis
ƒ Regulatory Requirements and Trends
ƒ Workshops on
- Qualification Tests
- Development of a H2O2 Decontamination Cycle
- Sterility Test isolators in Routine

Participate in three workshops at SKAN AG

Programme

Objective Sterility Test Isolators: Standard Process under

Control
Why should you attend this event?
ƒ You get an update on isolators for sterility testing ƒ Key decisions: sterility testing in isolator vs. cleanroom
ƒ You get to know the results of recent studies on the ƒ ost comparison
C
validation of isolators ƒ From URS to isolator
ƒ You have the opportunity to discuss your individual ƒ Technical details and solutions
questions personally with experts ƒ Airflow and decontamination system
ƒ You can translate the theory directly into practice during 3
workshops at the manufacturing site of Skan in Allschwil Customer Benefit for Standardized Software

Each participant takes part in all 3 workshops. The workshops ƒ Define SKAN standards acc. GAMP V
are held at the plant of SKAN AG, partly including operational ƒ I ntegration of customer specific requirements
isolators. This brings the participants as close to daily practice as ƒ Minimizing the engineering costs due to standardization
possible. ƒ Safe internal and external interfaces – Data integrity

Bioindicators / Process Development of Isolator

Background Decontamination

The consequences of a failed sterility test are enormous. The use ƒ O verview of current regulations and standards
of Sterility Test Isolators offers a much safer way to avoid false ƒ Basis and selection of suitable biological indicators as
positive results. That’s why the use of isolators for sterility te- sensor for the inactivation effect
sting has become a standard in the pharmaceutical industry and ƒ Development and quantification of decontamination
in microbiological contract laboratories. But at the same time cycles
Isolator Technology requires an increased input with regard to ƒ Influence of H2O2 to routine processes
the qualification of these systems and the validation of the de-
contamination process. Isolators Used for Sterility Testing
In 2004, Appendix 1 to the FDA Guidance for Industry „Sterile
Drug Products Produced by Aseptic Processing“ defined new re- ƒ Requirements for the isolator
gulatory requirements on using this technology, as did the PIC/S - Background of the isolator
document PI 014-3 „Isolators used for Aseptic Processing and - Performance Qualification
Sterility Testing“ and the expected revision of EU GMP Annex 1. - Qualification of operators
- Test for gas-tightness of primary packaging materials
ƒ Handling in isolator
Target Audience - Capacity
- Testing the tightness of gloves
This GMP Education Course addresses those employees from the ƒ Microbiological Monitoring
pharmaceutical industry and from suppliers / contract organisa- - Sample plan
tions involved in the engineering, validation and operation of - Contamination level
Sterility Test Isolators, especially from the areas - Contamination source
ƒ Engineering - OOS/CAPA (example)
ƒ Quality Assurance
ƒ Qualification/ Validation Troubleshooting in Isolator Technology
ƒ Microbiology
ƒ Th
e place of the isolator in a pharmaceutical process
The number of participants is limited. ƒ The influence of critical parameters on the decontaminati-
on process
Please understand that, for competitive reasons, not all firms ƒ The reliability and reproducibility of biological indicators
can register their employees for this event. ƒ The expectations of regulators

Gone with the Wind – How Are we Doing with a

Programme SkanFog® Sterility Test Isolator?

Regulatory Requirements for Sterility Test Isolators ƒ From clean room to isolators
ƒ hy SkanFog® for sterility test isolators?
W
ƒ Regulatory bodies ƒ Our 3 isolators and a bit technology
ƒ S laws and regulations
U ƒ Performance Qualification
ƒ European laws and regulations ƒ The new lab building @ Bayer Berlin
ƒ Guidelines ƒ Double challenge: New lab building and new technology
ƒ Basic Isolator definitions ƒ Lessons learned

Isolator Technology Workshop – Sterility Test Isolator | 3-4 June 2020, Basel, Switzerland
 Speakers

Alternative Sterility Testing Methods: Experience Speakers

Feedback and Outlook
Dr Michael Daferner, Bayer AG, Berlin
ƒ xperience feedback regarding alternative method
E Dr Daferner joined Bayer Healthcare Leverkusen in 2002 as Laboratory
ƒ Outlook Head Microbiology Quality Control. From 2003 to 2009 he worked at
ƒ Challenges Vetter Pharma Ravensburg as Team Manager and Laboratory Head in
ƒ Impact on Sterility Test Isolators Microbiology Quality Control. Since 2009 he is Laboratory Head Micro-
biology Quality Control / Development Products at Bayer Pharma Ber-
lin.

Workshop Session Christian Doriath, SKAN AG, Basel, Switzerland

Christian Doriath joined SKAN in 2012 after more than 20 years spent
Workshop 1: Validation Planning for an Sterility Test on isolator technology in the pharmaceutical industry at various posi-
Isolator tions, maintenance, validation, research, technical services. Since Octo-
ƒ Test master plan (IQ/OQ) ber 2018 he is Head of Process Validation Microbiology at SKAN
ƒ IQ / OQ test protocols
ƒ Operational qualification - procedures Patrick Graser, SKAN AG, Basel, Switzerland
ƒ Handling of deviations Patric Graser joined SKAN in 2009. Today he is Head Hardware Planning
at SKAN AG responsible for electrical engineering.
Performance of Selected Qualification Tests
ƒ Basic SOP for testing Theresa Ladwig, SKAN AG, Basel, Switzerland
ƒ Execution of tests In 2007 Theresa Ladwig joined SKAN AG as a Project Engineer in the de-
ƒ Generate test records partment Cycle Development and performed Cycle Development and
ƒ Drawing up the test report Microbiological Qualifications all over the world. From 2013 to 2018 she
ƒ Glove testing was Head of Process Validation Microbiology. Today she supports the
Sales Team for Europe of Skan AG.
Glove Integrity Testing
ƒ Regulatory Background Elodie Muller, Novartis Pharma Stein, Switzerland
ƒ Physical methods for glove integrity tests and their Elodie Muller holds a Master’s Degree in microbiological quality control
boundaries and quality assurance. She joined Novartis in 2017 after several years of
ƒ Microbiological contamination risk experience in the microbiological quality control, especially in sterility
ƒ Routine program for glove integrity testing testing (compendia and rapid method). She is currently team leader of
the sterility testing laboratory at Novartis Aseptics Stein.
Workshop 2: Development and Quantification of H2O2
Decontamination Cycles Alain Ribstein, SKAN AG, Basel, Switzerland
ƒ Establish the requirements of a decontamination Alain Ribstein studied mechanical engineering at the ESTA school of
cycle business and technology in Belfort, France. He joined SKAN AG in 2012
ƒ Design a qualification strategy after performing his master thesis in the sales engineering department
ƒ Work out the necessary physical and microbiological and is now since 2017 Sales Manager in the Process Solution for Isolator
tests and their chronology Technology. He is responsible for the area of Austria and East Europe.
ƒ Interpretation of test results and reaction on
deviations Katharina Schlereth, Labor L+S AG, Bad Bocklet,
ƒ Write a transparent qualification report Germany
ƒ Workshop including a real isolator system Katharina studied Biology at the University Würzburg. 2009 she joined
Labor L+S AG in Bad Bocklet, Germany, where she is responsible for ste-
Workshop 3: Sterility Test Isolators in Routine rility testing. Her current position is Division Head, Microbiological Te-
ƒ Handling in isolators sting of Sterile Products.
ƒ Personnel at isolators
ƒ RTP / airlock system Yves Scholler, SKAN AG, Basel, Switzerland
ƒ Parametric release Yves Scholler studied mechatronics at the Trinational Engineering
ƒ Frequency of decontaminations School (FTI) in Muttenz (CH), Mulhouse (F) and Lörrach(D). He joined
ƒ Point of view of a user SKAN AG in 2007 and is now Head of Sales Europe in the Process Solu-
ƒ Point of view of regulatory tion for Isolator Technology.

You will take part in all workshops!

The workshops will take place at SKAN AG in Allschwil. Social Event
After the workshops, at appr. 16.15 h, a bus shuttle service
will bring the participants to the airport (appr. 16.35 h), the On 3 June you are cordially invited to a social event. This is an excellent
German train station (appr. 16.50 h), the Swiss train station opportunity to share your experiences with colleagues from other com-
(appr. 17.15 h) or the hotel. panies and the speakers in a relaxed atmosphere.

Isolator Technology Workshop – Sterility Test Isolator | 3-4 June 2020, Basel, Switzerland
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Isolator Technology Workshop – Sterility Test Isolator, 3-4 June 2020, Basel, Switzerland
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