Contamination Control

Contamination Control

Berlin, Germany

Course No 9136


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Irene Heiderich, Boehringer Ingelheim, Germany
Werner Hofstetter, Octapharma, Austria
Arjan Langen, MSD, The Netherlands
Markus Schad, decontam, Germany
Axel Schroeder, Concept Heidelberg, Germany
Robert Schwarz, Baxter, 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
Microbial Growth
Basic hygienic actions
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
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
Case study for qualification of disinfectants
Efficacy – how to control?

Cleaning and Disinfection of Surfaces
Criteria of selection of disinfectants
Rotation of antimicrobial substances
Considering their chemical interaction
Cleaning potential of disinfectants
Users acceptance

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

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

Effective Training of Operators
Regulatory requirements (EU-GMP, FDA Guidelines, experiences from inspections)
Methods and tools
Measurement and documentation of training success
Practical approaches

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