Modern Cleanroom Technology

Objective

This conference will present state-of-the-art examples of cleanrooms, cleanroom technology and entire facilities. Requirements by the revised Annex 1 are thereby highlighted.

Registration


Background

Knowing the regulatory requirements on rooms and HVAC systems is an absolute prerequisite for all further steps like design, qualification and operation of clean rooms.
It is therefore essential to be aware of all restrictions and relations between material and personnel flows before starting with the building of clean rooms for pharmaceutical manufacturing. This is the starting point for the zone concepts and the required airlocks.
Depending on the product or project requirements, other points must also be considered, such as the filter technology, the design of the HVAC system and possibly tightness tests.
The clean room itself consists of floor, wall and ceiling systems suitable for the intended use. Now, which systems are suitable for which clean zones or processes? How can an isolator be integrated in the concept? And what is the impact of the revised Annex 1 on clean rooms and HVAC systems?

Target Audience

This conference is directed at specialists in pharmaceutical engineering departments and production, involved in the planning, qualification or operation of pharmaceutical manufacturing environments. Engineering companies and GMP-planners are also the target group of this conference.

Detailed Programme

Tuesday, 19 March 2024

Current Zoning Concepts for special Requirements
Andreas Nuhn, D&B Pharmadesign

  • Zoning according to the new Annex 1
  • Zone concepts for non-sterile dosage forms
  • Special zone concepts and examples for
  • Cytological products
  • Radiopharmaceuticals
  • Biological products BSL 3

Case Study Stulln Pharma - Design of a new Facility for Sterile Production
Nikolaus Ferstl, University Hospital of Regensburg

  • General site master plan
  • Production layout
  • Facility and supply concept
  • HVAC & zone concept
  • Cleanroom walls, ceiling & floor

New Cleanroom / Barrier System Requirements from Annex 1
Dr Jean Denis Mallet, Former head of the French Inspection Department AFSSAPS, Pharmaplan

  • Premises
    • Is the traditional escalation D/C/B/A modified in Annex 1?
    • What is a 'new' airlock? What is a 'modern' air pressure cascade? What about continuous monitoring?
    • How to demonstrate that the aeraulic patterns are really those expected?
    • In which extent a barrier system can be considered as a premise?
  • Equipment
    • Can we easily change the room design from an isolator system to a RABS system?
    • Is it interesting to combine RABS and isolators for the same filling line?
    • What is the best configuration for an aseptic vial capsuling machine?
  • Personnel
    • How should we be qualified to enter in cleanrooms? D/C ... B/A?

Implementation of the new Requirements of EU GMP Annex 1 from Boehringer Ingelheim's Perspective
Dr Lars Kreye, Boehringer Ingelheim

Fulfilling GMP Requirements for new Facilities vs older Facilities
Daniela Jahn, Boehringer Ingelheim RCV

  • Layout designs and layout requirements for GMP facilities have changed over the time. Therefore, older facilities are regularly upgraded to comply with the current standards
  • Inclusion of Good Engineering Practice to a risk based clean room qualification approach
  • Requirements according to new Annex-1: risk based approach for requalification of non-sterile areas
  • The path forward to sustainability: clean air downregulation at non-working hours as an example

Green GMP in Cleanrooms – Contradiction or Opportunity
Dr Johannes Krämer, CSL Behring

  • Compatibility of GMP and Sustainability?
  • Approaches to sustainability in existing cleanrooms
    • Cleanroom operation/design/equipment
    • Plant and process operation
    • Maintenance/calibration
  • Holistic approaches for new planning
    • Energy efficiency by process design
    • Thermal optimisation
    • Sustainable refrigeration
    • Minimising water consumption

Wednesday, 20 March 2024

HVAC-System Design for a High Potent Facility
Nikolaus Ferstl, University Hospital of Regensburg

  • Cleanroom Classification & Pressure Zones
  • HVAC Zoning and Segregation
  • HVAC Supply Concepts
  • Design Parameters
  • Filtration Systems
  • Tightness and tightness testing
  • Examples, practical solutions

Setup of a Contamination Control Strategy Using the HACCP Methodology
Ruben van der Galiën, GE HealthCare

  • Application of the Hazard Analysis Critical Control Point (HACCP) methodology to monitor all Critical Control Points (CCPs) related to various sources of contamination
  • Description of the way how to set up a CCS within a pharmaceutical sterile and aseptic manufacturing facility applying the HACCP methodology
  • Use of the HACCP methodology enables a company to include proactive data within the CCS, making use of all identified sources of contamination, associated hazards, and/or control measures and CCPs
  • The constructed CCS allows the manufacturer to identify whether all included sources of contamination are under control and, if not, which mitigatory actions need to be performed

Airflow Visualization within the critical Zone of Cleanrooms and Barrier Systems
Luigi Scaffidi, Boehringer Ingelheim Pharma

  • Regulatory requirements
  • Prerequisites, techniques, operating states, relevant process steps, life cycle
  • Selection of tracer particles (What's the deal with neutral buoyancy?)
  • Case studies

Cleanroom Performance Testing According ISO 14644
André Lourenco, NNE

  • Introduction to Cleanroom Testing
  • Strategy for Cleanroom Testing
  • Practical Examples

Case Study IPA Fraunhofer: Horizontal vs. vertical unidirectional Airflow Directions
Dr Markus Keller, IPA Fraunhofer

  • New GMP Annex 1: first air principle
  • ISO 14644-1: Examples from Space, MedTec, semiconductor industries
  • Visualization setup regarding airflow studies for open vials
  • Particle fallout risk assessment using silicon wafers as witness samples: Case scenarios:
    • Displacement pipetting robot with vertical airflow
    • Isolator with horizontal airflow

Assessment of microbial Contamination in a sterile Production Environment
Doris Laçej, Profarma

In practice, environmental monitoring has shown that even a validated cleaning method using certified agents can lead to the presence of atypical microorganisms that exceed GMP limits.

  • Challenges in the root cause analysis
  • Integration of new disinfection methods
  • Semi-automatic-disinfecting systems to eliminate Aspergillus Niger in grade A and C clean rooms
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