Contamination Control Strategies
Im Auftrag der ECA Academy

Contamination Control Strategies Im Auftrag der ECA Academy

Barcelona, Spain

Seminar Nr. 17643


Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Werner Hofstetter, Octapharma, Austria
Arjan Langen, GE Healthcare, The Netherlands
Carsten Moschner, Dastex, Germany
Inga Marie Schlägl, Bayer, Germany
Axel Schroeder, Concept, Germany
Robert Schwarz, FH Campus Vienna, Austria
Wolf-Dieter Wanner, Germany


In most cases the implementation of appropriate hygiene programmes and measures have been implemented as an essential part for the manufacturing of pharmaceutical products. A series of regulations address the subject of microbiological facility control but GMP requirements are mostly described in more general terms. But how can they be introduced in pharmaceutical companies in a practice-oriented way? What is state-of–the-art? How should detergents and disinfectants be used?

The overall goal of such a system is to prevent microbiological contamination of the pharmaceutical product. But even if such a system has been established, it is of utmost importance that these programmes and measures are understood and followed by all operators who carry out quality-relevant work. Therefore, regulations demand intensive training in hygiene issues.

Against the background of these requirements, this ECA education course is designed to cover all important aspects of controlling microbiological contamination. It ranges from sources of contamination to validation of cleaning and disinfection processes and training of operators. A focus will be on those problems that occur frequently in pharmaceutical production; possible solutions to these challenges will be discussed.


The lack of control of microbiological contamination is an outstanding integral part of inspection findings.

This actual state clearly demonstrates the importance to concern oneself with this topic in Detail.

In pharmaceutical manufacture, cleaning and disinfection measures are important and decisive process steps for fulfilling the quality requirements on the medicinal product. To carry them out properly, personnel needs to be both qualified and motivated.

All national and international pharmaceutical GMP regulations - especially those on sterile manufacturing - call for cleaning and hygiene programmes in the pharmaceutical companies.


People who are involved in
  •  Microbial Monitoring
  •  Implementation of Hygiene Programmes
  •  Selection and Qualification of Disinfectants
  •  Handling of microbial Deviations
  •  Training of Operators for Monitoring


Module 1: Requirements and Background
Basic Principles of Microbiology, Hygiene and Contamination Control
  • Microorganisms
    • Microbial Growth
    • Characteristics
    • Sources
  •  Basic hygienic actions
  •  Cleaning/disinfecting/Sterilization
  •  Way of Contamination
Regulatory Requirements
  •  General regulatory requirements and guidelines
  •  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
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?
Module 3: Basics and Implementation of a Cleaning/Disinfection Strategy
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
  •  Different gassing systems
  •  Guidance documents, standards and regulatory requirements
  •  Basis for qualification
  •  Case study for qualification of disinfectants
  •  Efficacy – how to control?
Case Study: Managing Disinfection Programmes
  •  Hygiene programme
  •  Cleanroom concept
  •  Demands on environment, equipment and personnel
  •  Cleaning and disinfection concept
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:
  1. Case Studies: Disinfections Issues
    Practical examples of microbial deviations after cleaning and disinfection activities. Causes, faults and correcting actions.
  2. Handling of OOS Results
    Failure investigation, following corrective actions and preventive actions.
Hygiene of Personnel – Cleanroom Behaviour
  •  Contamination from Personnel
  •  Classic Employee Deviance
  •  Gowning procedure
  •  Hand disinfection
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
Module 4:  Additional Challenges  
Quality Risk Management
  •  Risk Assessment:
  •  Risk Identification
  •  Risk Analysis
  •  Risk Evaluation
  •  Risk Management
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
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?


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