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.

Course outline:

Module 1 - Requirements and Background

• Basic principles of hygiene and microbiology
• Regulatory requirements
• Sources of contamination and preventive measures
• Microbiological monitoring
• Trending of environmental monitoring data
• Microbiological control of water systems
• Qualification of disinfectants

Module 2 - Implementation and Issues in Real Life

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:

• Case Study 1: Disinfection Issues

Practical examples of microbial deviations after cleaning and disinfection activities. Reasons, faults and corrective actions.

• Case Study 2: Handling of OOS Results

Hygiene of personnel – cleanroom behaviour

Validation of a decontamination system for production equipment, process devices and cleanrooms

Quality risk management

Cleanroom garment, requirements, selection and laundering

Effective training of operators

Cleanroom consumables - a so called „cent-product“ but with consequences

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