Contamination Control

Contamination Control

Berlin, Germany

Course No 16425


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Werner Hofstetter, Octapharma, Austria

Arjan Langen, MSD, The Netherlands

Carsten Moschner, dastex, Germany

Dr Inga Marie Schlägl, Bayer, Germany

Axel Schroeder, Concept Heidelberg, Germany

Robert Schwarz, FH Campus Vienna, Austria


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.

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 microbiological validation of 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.

Furthermore, this education course clarifies uncertainties concerning microbiological facility control and provides helpful suggestions for compliance with regulatory demands. Experienced specialists share their expert knowledge with the participants.


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

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

Between 1995 and 2005, the potential risk of microbiological contamination was the No 2 Critical GMP Deficiency and the No 1 Major GMP Deficiency observed during inspections requested by the CHMP/CVMP of EMEA.

MHRA’s review of the deficiencies 2011/2012 issued 57 deficiencies related to personnel as well as 75 contaminations by chemical/physical and microbial causes.

Increasing number of FDA warning letter to sterile manufacturers in 2014:
Total Number 2013 – 16 WL
After six month 2014 – 19 WL

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.

Target Group

Persons 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 Hygiene and Microbiology

  • 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
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
Trending of Environmental Monitoring Data
  • How do you do it?
  • What do the results really tell you?
  • How should you react on the results?
Microbiological Control of Water Systems
  • Water as raw material
  • Contamination sources within the water system
  • Technical aspects
  • Control methods
  • Microbiological testing of water
Qualification of Disinfectants
  • Different gassing systems
  • Guidance documents, standards and regulatory requirements
  • Basis for qualification

  • Module 2: Implementation and Issues in Real Life

    Case Study: Managing Disinfection Programmes
    • Hygiene programme
    • Cleanroom concept
    • Demands on environment, equipment and personnel
    • Cleaning and disinfection concept
    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: Disinfection Issues
    Practical examples of microbial deviations after cleaning and disinfection activities. Reasons, faults and corrective 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
    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
    Effective Training of Operators
    • Regulatory requirements (EU-GMP, FDA Guidelines, experiences from inspections)
    • Methods and tools
    • Measurement and documentation of training success
    • Practical approaches
    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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