Pre-Conference Programme: 19 August 2026

This half-day workshop focuses on practical approaches to managing contamination risks associated with material flow and transfer within GMP cleanroom environments, in alignment with the expectations of EU GMP Annex 1 and Contamination Control Strategy (CCS) principles.

Participants will gain a structured understanding of material transfer pathways from warehouse to critical cleanroom zones, with emphasis on identifying contamination risks across cleanroom grades and implementing effective mitigation strategies.

The session will also cover key considerations in surface cleaning and disinfection programs, including disinfectant selection, contact time, residue management, and integration of sporicidal agents.

Through a combination of classroom learning and interactive group exercises, attendees will apply concepts to realistic scenarios, including material transfer risk mapping and cleaning program design. Practical demonstrations may further illustrate best practices in wiping techniques and material handling.

This workshop is designed to bridge regulatory expectations with real-world application, equipped participants with practical tools and frameworks to strengthen their contamination control strategies.

Led by:

Daniel Klein, Director, Technical Services, STERIS Corporation, USA

Dan has over 30 years of industry experience. At STERIS Life Sciences, Dan provides technical expertise to Customers and helps troubleshoot and solve contamination issues. He supports Customers with a variety of critical processes and general understanding of the latest developments in the industry.

Richard Chai, Senior Manager, Technical Services, STERIS Corporation, Singapore

Richard has over 20 years of industry experience. He has been providing technical support and training to customers related to contamination control for cleanrooms & process equipment cleaning process. He has extensive experience in helping customers to resolve cleaning issues. 

The EU GMP Annex 1 revision reinforces contamination control as a central pillar of sterile manufacturing, requiring a holistic, risk-based approach across all process steps. As single-use technologies expand from freeze–thaw and formulation to filtration and final filling, manufacturers must rethink how process design, validation, and compliance are integrated within flexible and modular facilities.

Key expectations now extend beyond traditional aseptic control to include integrity assurance, material compatibility under challenging conditions such as freeze–thaw, effective implementation of PUPSIT, and robust supplier quality and data integrity frameworks. At the same time, contamination control strategies (CCS), barrier technologies, and environmental and process monitoring must be consistently demonstrated in an inspection-ready manner.

This workshop brings together practical insights into building end-to-end, risk-based processes. We will explore how to align frozen drug substance handling, filtration, and filling operations within a coherent and defensible CCS, while ensuring process robustness, filter performance consistency, and reliable integrity testing.

Participants will gain a clear perspective on designing compliant, efficient, and resilient single-use operations that safeguard product quality, operator safety, and patient protection in line with evolving regulatory expectations.

Led by:

Dickson Chee, Product Specialist, Sartorius, Singapore

Since 2025, as the Asia Fill Finish Product Specialist, he support stakeholders and leads the business strategy for the fill finish portfolio in Asia. He has previously worked at Shire and Takeda in Singapore.

Micheal Schafferius, Product Specialist ST Filtration, Sartorius, Singapore

Micheal has 20+ years of experience in pharma and biopharma. A recognized expert in filtration, single-use technologies, and sterile manufacturing, he is a frequent speaker on filter integrity testing.

Markus Junior Maring, Product Manager, Sterile Filtration, Sartorius, Singapore

With over 15 years' experience in the biopharmaceutical industry and a background in microbiology and engineering, Markus has developed deep expertise in validation and regulatory topics.

Ivy Chuang, Project Manager Validation Services, Sartorius, Singapore

Ivy is experienced across downstream bioprocessing, from laboratory process development to GMP manufacturing.  supporting customers with validation solutions for biopharmaceutical manufacturing.

Maheshkumar Vairamani, SU Development Senior Engineer, Sartorius, Singapore

Maheshkumar has experience working with Class I, II, and III medical devices, including both hospital products and implantable devices. He currently supports Freeze and Thaw applications contributing to the development of innovative single-use bioprocess solutions. 

Visit this state-of-the-art flow calibration facility, a process training unit and interactive technology demonstrations under one roof. The integrated facility demonstrates measurement technologies and solutions in a real-world, application-driven environment. 

By combining calibration, training and live demonstrations, the TECH Centre supports closer collaboration with customers throughout the lifecycle of their processes. 

www.sg.endress.com

“The new TECH Centre allows us to work closer with customers and turn real-world application challenges into practical solutions.”

— Mr Richard Yu, Managing Director, Endress+Hauser Singapore