Environmental Monitoring

Environmental Monitoring

Copenhagen, Denmark

Course No 16732

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Speakers

Colin Booth, Binding Site Group Ltd, UK

Christopher Randell, CooperVision, UK

Dr Björn Wiese, Zimmer GmbH, Switzerland

Objectives

Environmental monitoring is one of the systems that decide about the product quality in the manufacture of sterile medicinal products. Both European and American GMP regulations place special focus on this topic.

The USP 1116 and especially the FDA’s “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice“ deal in detail with environmental monitoring.

However, many of the requirements laid down in these documents seem to be excessive for everyday practice on the one hand and leave great scope for interpretation on the other hand.

In practice, environmental monitoring programmes sometimes develop into time-consuming, cost- and personnel-intensive measures. Therefore, it is the aim of this course to provide the participants with pragmatic recommendations for the creation and implementation of environmental monitoring programmes.
Within the framework of this course, the participants are confronted with current hot topics, like:

  • Alert / action levels
  • Relationship to batch release
  • Locations and frequency
  • Identification of isolates
  • Sampling procedures
and get to know solutions for their own company practice.

Target Group

This Education Course is directed at staff from Production, Quality Assurance and Quality Control who is responsible for the planning and implementation of environmental monitoring programmes.

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.

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