- Why do we do it – what does it tell us?
- EU-GMP Guide Annex 1 (revision)
- USP <1116>
- FDA Aseptic Processing Guide
- ISO 14644 and ISO13824
- An overview about the most important guidances
Surface / Personnel Monitoring
- Surface sampling techniques
- When and how?
- Results and specifications
- How to deal with shedders/pathogen carriers.
Viable Air Monitoring
- Regulatory Standards
- Settle Plates
- Drying Issues
- Where to place them?
- Active Air Sampling
- Equipment options / comparison
- Where to place them?
Clean Rooms – RABS – Isolator: Points to consider in Environmental Monitoring
- Comparison of the technical concepts
- Validation of microbiological media for the isolator
- Selection of sampling points
- Transfer of microbiological media
- Interpretation of the results and handling of excursions
Non-viable (particulate) Air Monitoring
- The grading of areas for manufacture of sterile medicinal products in the EU
- How to claim classification of areas to current standards
- How to ensure continuing compliance with the classification
- Selection of sampling locations for qualification and routine
- Particle monitoring, how and how often
- Handling the data
Case Study: Programme / Use of FMEA to Determine Sample Points in Routine Monitoring
- Identifying weaknesses in contamination control systems
- Identifying locations which will provide “early warning” signals of loss of control
- Preparing useful environmental monitoring SOPs
- Keeping manageable records
Case Study: Trending of Environmental Monitoring Data
- What is a trend?
- How can I use electronic systems to track and trend EM data?
- How to get meaningful information from trending
- Alert and action level setting
- Using trending as tool for pro-active environmental control measures
- Microbiological media, growth requirements
- Identification of isolates
- Validating your methods
- Using rapid identification techniques
- Recovery problems
- Identification to the level of DNA, what value does it bring
Environmental Monitoring for Non-Steriles
- Why monitor non-sterile areas
- Risk vs impact
- Overview of regulatory position
- Case study
Deviation Management for Environmental Monitoring
- Steps to be taken in case of excursions
- When is an excursion a deviation?
- Comprehensive root cause analysis
- The nasty “re-occurrence”
- Finding of appropriate actions
Case Study: Interpretation of OOS Results
- What is an OOS in environmental monitoring?
- OOS in relation to trends
- How to investigate
- Follow-up and corrective actions
- Consequences for batch release
Investigations / Documentation
- The information content of “variable” data versus quantitative limits
- Published and practical limits
- The information content of qualitative data
- Communicating with technical management and higher management