Module 1: Regulatory Requirements and Background
Basic Principles of Microbiology, Hygiene and Contamination Control
- Microorganisms
- Microbial growth
- Characteristics
- Sources
- Basic hygienic cctions
- Cleaning/disinfecting/sterilization
- Way of contamination
Regulatory Requirements
- General regulatory requirements and uidelines
- Prevention of contamination and cross contamination
- Requirements for validation
- ISO standards
- Quality Risk Management
Sources of Contamination and Preventive Measures
- Sources of contamination throughout the facility
- HVAC
- Water
- Raw materials and packaging components
- Personnel and clothing
Effective Training of Operators
- Regulatory requirements (EU-GMP, FDA Guidelines, experiences from inspections)
- Methods and tools
- Measurement and documentation of training success
- Practical approaches
Module 2: Monitoring and Control Strategies
Microbiological Monitoring
- Monitoring of non-sterile processes
- Aseptic manufacture:
- developing a Programme
- interpreting data
- regulatory requirements
- Monitoring methods, air, surface, people
- A complete programme for a sterile product
Cleanroom Garment - Requirements, Selection and Laundering
- Different fabrics and their characteristics like filtration capacity and wearing comfort
- Garment systems oriented by the cleanroom class
- Requirements on decontamination and laundering
- Outsourcing
- Single-Use consumables
Microbiological Control of Water Systems
- Water as raw material
- Contamination sources within the water system
- Technical aspects
- Control methods
- Microbiological testing of water
Trending of Environmental Monitoring Data
- How do you do it?
- What do the results really tell you?
- How should you react on the results?
- Criteria of selection of disinfectants
- Rotation of antimicrobial substances considering their chemical interaction
- Cleaning potential of disinfectants
- Users' acceptance
Module 3: Cleaning/Disinfection – Measures, Pit Falls, Deviation Handling
Cleaning and Disinfection of Surfaces- Criteria of selection of disinfectants
- Rotation of antimicrobial substances considering their chemical interaction
- Cleaning potential of disinfectants
- Users acceptance
Qualification of Disinfectants
- Guidance documents, standards and regulatory requirements
- Basis for qualification
- Case study for qualification of disinfectants
- Efficacy – how to control?
Hygiene of Personnel – Cleanroom Behaviour
- Contamination from personnel
- Classic employee deviance
- Gowning procedure
- Hand disinfection
Case Study: Managing Disinfection Programmes
- Hygiene Programme
- Cleanroom Concept
- Demands on environment, equipment and personnel
- Cleaning and disinfection concept
Validation of a Decontamination System for Production Equipment, Process Devices and Cleanrooms
- Technical requirements & background
- Qualification of a fogging system
- Validation of a fogging process
Parallel Workshops
During the second day, parallel workshops will be conducted in order to reinforce the content of the lectures and to discuss practical aspects in detail.
Workshops will be offered on the following topics:
- Case Studies: Disinfections Issues
Practical examples of microbial deviations after cleaning and disinfection activities. Causes, faults and correcting actions. - Handling of OOS Results
Failure investigation, following corrective actions and preventive Actions.
Module 4: Additional Challenges and Annex 1-compliant Overarching Strategies
Cleanroom Consumables - a so called „Cent-Product“, but with Consequences
- Definition of cleanroom consumable products
- The impact during the daily application
- How is that reflected in guidelines?
Quality Risk Management
- Risk assessment:
- Risk identification
- Risk analysis
- Risk evaluation
- Risk management
Contamination Control Strategy - An Interdisciplinary and Dynamic System
- Formulate a CCS
- Implement a CCS and develop a strategic plan to make the strategy work as intended by mapping/designing the organizational structure, procedures, control processes, distributing resources, developing the decision-making processes, etc.
- Evaluate the CCS efficiency to ensure process performance and product quality while improving the CCS level over time.
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Seminarprogramm als PDF