Environmental Monitoring

Programme

Environmental Monitoring
Why do we do it – what does it tell us

Relevant Guidelines

• EU-GMP Guide Annex 1
• USP <1116>
• FDA Aseptic Processing Guide
• ISO 14644 and ISO13824
• An overview about the most important guidances

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

Viable Air Monitoring

• Regulatory Standards
• Settle Plates
• Validation
• Drying Issues
• Where to place them?
• Active Air Sampling
• Equipment options / comparison
• Validation
• Where to place them?

Surface / Personnel Monitoring

• Surface: How?; Surface sampling techniques; Limitations; Validation?
• Personnel: When and how?; Results and specifications; How to deal with shedders/pathogen carriers.

Case Study:
Trending of Environmental Monitoring Results

• 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 Methods

• 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

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

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

Investigations / Documentation

• The information content of “variables” data versus quantitative limits
• Published and practical limits
• The information content of qualitative data
• Communicating with technical management and higher management

Workshop
How to Establish an Environmental 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

Most personnel in the pharmaceutical industry inherit environmental monitoring programmes from the past and rarely get the opportunity to establish a programme for the regulatory requirements and first principles. This session gives participants hands-on experience of working with the regulations and standards versus simplified but “real-life” situations. It is intended to encourage participants to leave with a new outlook on what is being done in their own facilities with a view to improving compliance and adding value.