Cleanroom Garments – Clothing Basics, Barrier Functions and more
Jörg Mesenich, Mesenich Consulting
Gabi Schmeer-Lioe, German Institutes for Textile and Fibre Research Denkendorf (DITF)

• Understanding garments as a system
• What regulations exist today
• Characteristics for the evaluation of cleanroom garments
• Testing of cleanroom garments
  
  

Qualification Study for Cleanroom Garments
Carsten Moschner, CMC3

• Why necessary (see Annex 1)?
• How should such a study be structured?
• What needs to be considered?
  
  

Disposables – Face Masks and the Like – whatProtection do they really provide?
Monika Lamprecht, Lamprecht Consutling & Coaching

• Face masks, bonnets, disposable clothing
• Material requirements
• Suitable for which cleanroom class
• Wearing characteristics
  
  

Cleanroom Wipes – What is Cleanroom-Compatible really?
Carsten Moschner, CMC3

• Wipes as a component of a (wiping) cleaning procedure
• Basic textiles and their properties
• Technical documentation - what to look out for
• Pre-soaked wipes: advantages and disadvantages
  
  

Mopping Systems and the associated Systems
Margarete Witt-Mäckel, Witt Hygienemanagement

• Cleanliness suitability/cleanroom suitability
• GMP conformity
• Qualification and validation - equipment and processes

Cleanroom Gloves – the Balancing Act between Cleanroom Suitability and Personnel Protection
Monika Lamprecht, Lamprecht Consulting & Coaching

• Areas of use and applications of gloves
• Selection and use of protective gloves
• Cleanroom suitability
• Material durability to substances used, restrictions and breakthrough times
  
  

Facility Monitoring with Single-Use active viable Sampling in the daily Practice of a Contract Developer and Manufacturer – Complete and simple Solution
Dr Thomas Müller, Recipharm
Ivan Spiro, Particle Measuring Systems

• Compliant continuous active air sampling with evaluate impaction procedure
• No settle plates needed
• Extended air sampling time
• Process safety
  • Continuous particle counting
  • Real-time evaluation of the collected data by the Facility Monitoring System combined for the filling lines and neighboring production rooms
  • Data Integrity
    
    

Pitfalls in Microbiological Cleanroom Monitoring: Common Sources of Error in Qualification and Ongoing Monitoring
Melanie Braun, Labor LS

• The most common sources of failure
• What happens when things go wrong? Causes and consequences
• How to do it better
  
  

Live Demos

Facility Monitoring Systems
Particle Measuring Systems

Continuous and Rapid Monitoring of Bacteria in Pharmaceutical Grade Water
BWT Pharma & Biotech GmbH

Surface Properities of Stainless Steel – how the adhesion behavior of products can be influenced by modifying stainless steel surfaces
Bolz Intec

Case Study: Disinfectants and their Effectiveness on various Surfaces
Dr Hans-Joachim Anders, Novartis Pharma

• Disinfection efficiency testing
• Influence of Materials used on disinfectant and decontamination efficiency
• Introduction in microbe-carrier test for efficacy testing
• Effect of materials on hydrogen peroxide decontamination efficiency
  
  

Navigating the Challenges of implementing New Annex 1 in Non-Sterile Manufacturing
Martina Gjorgjevska, The Force CT
Apostol Todorovski, Sinceritas

• Introduction
  • Overview of Annex 1 and its significance
• The relevance of Annex 1 to non-sterile manufacturing operations
• Key areas where non-sterile manufacturers may be impacted
• Key Challenges
  • Understanding the Scope and Applicability
  • Strategies for Implementation
• Future outlook: How the industry can prepare for ongoing regulatory changes and enhancements