Cleanroom Challenges in Ongoing Operations
8/9 April 2025, Wiesbaden/Germany
Objective
In this conference track, we will present the expectations of regulatory authorities regarding the materials used, as well as provide insights into the requirements for qualifying such materials. Whether single-use or reusable, experienced speakers will introduce the properties, usability, and limitations of various consumables such as clothing, wipes, gloves, disinfectants, mops, etc., and will show you criteria that will assist you in selection and qualification.
Registration
Register as a congress delegate for just 690 EUR/day!
This special offer is only valid until 31 December 2024!
Background
In the production of pharmaceuticals, medical devices, cosmetics, or other products with high hygiene and quality demands, not only the "big" investments such as cleanroom planning and construction, design of production lines, ventilation systems, etc., play an important role, but often the pitfalls of quality assurance lie in the "small" materials, often referred to as "cent items" that are frequently used in daily routines. Gloves to protect products and/or personnel, wipes to clean surfaces, clothing—whether disposable or reusable—to reduce the human contamination source as a risk factor, or disinfectants to avoid or reduce contamination.
However, careful selection, qualification, and, if necessary, GMP-compliant preparation of these products and materials are of crucial importance. Clear specifications for materials regarding their purpose and location are essential. Guidelines such as VDI 2083, Sheet 9.2, or ISO 14644, Sheet 18 may provide users and decision-makers with references for their selection and definition processes.
Target Audience
The conference track is aimed at all those who deal with the following topics:
- Selection and qualification of single-use materials within quality assurance
- Purchasing and procurement of such materials
- Users of consumables in cleanrooms
- Personnel responsible for contamination control or contamination control strategies
- Employees of suppliers of consumable materials
- Staff from regulatory authorities
Moderators
Carsten Moschner, CMC3
Jörg Mesenich, Consultant
Speakers
Detailed Programme
Tuesday, 8 April 2025
09.00 - 17.30 h
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?
HIGHLIGHT
Consumables and Cleanroom – Expectations and Experiences of an Inspector
Dr Daniel Müller, Local Government Baden-Württemberg, Germany
- Regulatory framework and guidelines
- Inspector's expectation of consumables used in cleanrooms
- Experience from inspections, typical failures
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
Wednesday, 9 April 2025
09.00 - 18.00 h
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
Programme last upated: 6 December 2024