Inspector Training on Isolator Technology

Gain in-depth insights into modern isolator technology and contamination control strategies used in today’s aseptic manufacturing environments.

Over three days, the SKAN Inspector Training combines technical presentations, practical demonstrations and interactive workshops covering key topics such as isolator systems, glove management, transfer technologies, H₂O₂ decontamination, cycle development and validation, ventilation system qualification and data integrity concepts.

Participants will exchange directly with experienced SKAN experts and explore real production technologies during guided assembly hall tours featuring filling systems, transfer solutions and EBeam applications.

The training is designed to support inspectors and regulatory authorities in understanding current technologies, operational challenges and Annex 1 related expectations within aseptic processing.

Schedule

Welcome and introduction

Richard Denk

Isolator Basic

Isolators are seen as the most advanced technology providing grade A protection. In this presentation an overview will be provided where are still challenges seen as Glove Management, First Air, Isolator Set Up, Material Transfers in Grade A and about examples of Isolator design mistakes.

Richard Denk

Get to know the isolator

This presentation provides a deeper understanding of the isolator system, including its overall design, main functionalities and technical setup. Key topics such as airflow concepts, mock-up examples and system architecture will be explained using practical examples.

Lunch

Gloves on the isolator

Glove systems are a critical element in isolator technology and aseptic processing. This session covers Annex 1 requirements, glove types and selection, microbiological monitoring, contamination risks, pinholes and glove testing strategies to ensure product protection and operational safety.

Alex Kappani

Modern Transfer Systems and EBeam Technology

This session provides an overview of advanced transfer technologies used in isolator applications. Topics include EBeam decontamination, H₂O₂ airlocks and NTT systems, with a focus on contamination control, process integration and Annex 1 requirements.

Alex Kappani

Coffee Break

RTP Ports Demonstrating RTP performance for Annex 1 compliance

This session will present how RTP systems support compliance with Annex 1 requirements for aseptic transfer and contamination control. It will cover barrier integrity performance, including the Alpha Gloveless RTP and ULTRA™ system features (e.g., BetaBag), and their impact on first air protection. The presentation will also address how RTP design and leak-tightness contribute to the Contamination Control Strategy (CCS), along with qualification approaches and documented evidence supporting routine use. Finally, it will highlight maintenance strategies, including modular component replacement, to ensure sustained performance and inspection readiness.

Aurélie Mortier

Q&A

Richard Denk

Short city tour

Richard Denk

Meet the experts

Richard Denk

Meet your experts

Richard Denk

Consultant Aseptic Processing & Containment

Richard Denk has global expertise in aseptic processing and containment as Senior Consultant at SKAN AG, Switzerland. A recognized expert, he contributes to international industry bodies and regulatory initiatives, shaping standards for ATMP manufacturing, Annex 1, and advanced containment.

Francois Faul

Digital Solutions Manager

Francois Faul is Digital Solutions Manager at SKAN, guiding pharma companies on XR, VR, CFD, and Digital Twin to improve aseptic process design, engineering, and validation. With a master’s in Engineering and broad business experience, he creates tailored solutions for digital transformation.

Theresa Ladwig

Sterility Assurance Services Manager

Theresa Ladwig has been with SKAN AG since 2007, bringing extensive expertise in cycle development, microbiological qualification, and process validation across global projects. After leading microbiology validation and supporting European sales, she now focuses on the strategic development of SKAN’s process validation microbiology and SKANalytix service offerings.

Alex Kappani

Strategic Product Manager

Alex Kappani has worked several years as Product Manager for glove management at SKAN. During this time, he has helped numerous global Pharmaceutical companies to manage their gloves in their production facility.

Fabian Bihler

Sales Manager

Fabian Bihler has extensive experience in pharmaceutical and life sciences solutions. Working at SKAN, he has been instrumental in implementing advanced technologies, supporting customers in optimizing sterile manufacturing processes, facility efficiency, and innovative production workflows.

Guido Herzberg

Expert SKAN Academy Trainer

Guido Herzberg has more than 25 years experience in isolator qualification. Through reflection on standards and guidelines, he became a respected author of SOPs and checklists, as well as for the development of testing methods for metrological qualification activities.

Martin Novak

Technology Lead

Martin Novák has more than 10 years of experience in pharmaceutical R&D, with a background in drug synthesis and manufacturing. As Technology Lead at SKAN, he plays a key role in advancing decontamination strategies and isolator technology and contributes to international standardization as well as industry initiatives within PDA and ISPE.

Veronika Zysk

Administrative Laboratory Specialist

Veronika Zysk joined SKAN AG in 2000 as a Project Engineer in Cycle Development, carrying out cycle development and microbiological qualification worldwide. She later led the Cycle Development department and today is part of SKAN Laboratories, focusing on quality control and production of Biological Indicators.

Registration

Location

SKAN HQ

Kreuzstrasse 5, 4132 Allschwil, Switzerland
4132 Allschwil

For your visit to Basel, we recommend staying at the Holiday Inn Express & Suites Basel – Allschwil, located just a short walk from the SKAN HQ.

If you have any questions, please do not hesitate to contact us.

Contact