Puritan Enviromax and ESK for Surface Sampling

Contamination Control

2014, May 21 - 23

Pharmaceutical » Training

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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Kongresova 1
Czech Republic


Concept Heidelberg
Phone: +[49] 62 21/84 44 0
Email: info@concept-heidelberg.de
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