Laboratory Product Catalogue Total Laboratory Science Support

Training Examples for the Pharmaceutical|Biotech Industry
# 862024
Sterilization and integrity testing
of membrane filters
The participants in this training seminar on
steaming-in-place and integrity testing will
acquire theoretical knowledge and practical
experience in the handling of filters used in
sterile filtration.
Theoretical section
– Basic principles of filtration
(depth filters, membrane filters)
– Integrity testing of membrane filters
(methods, testing equipment)
– Physical and theoretical principles of
the steam sterilization of filter lines
Practical section
– Performing integrity tests
– Practical tests with in-line steam
sterilization of filter cartridge lines
Total course time
2 days
Target group
Staff working in the areas of production,
quality assurance and quality control.
# 862017
Microbiological quality control of sterile
products in clean rooms and isolators
Theoretical aspects
– Basic principles and regulatory requirements
for working under clean room conditions
– Monitoring of microbiological air quality
in clean rooms and isolators
– Basic principles of sterility testing according
to current pharmacopoeias
– Microbiological control of ambient
conditions and quality management in
drug manufacturing
# 862025
Implementation of PDA Technical
Report 26
The main focus of this course is on the
practical implementation of PDA Technical
Report No. 26, according to which any filter
validation must stand up to every audit.
Contents
– We will start by explaining the basic
differences between depth filters and
membrane filters and describe the
materials available for the production
of the respective filters.
– The different integrity tests will be
presented and their correlation to the
destructive bacteria challenge test will
be explained.
– A brief historical review of the development
of the cGMP idea with regard to
handling sterile filter elements will create
the groundwork for a more detailed
interpretation of the PDA TR 26.
– Using the example of the CONFIDENCE
Validation Service, the tests and analyzes
to be conducted will be explained. Additionally
we will describe how they should
be conducted in order to implement
cGMP theory successfully.
– A concluding discussion gives the participants
the opportunity to ask questions
about their daily work and identify ways
to solve problems.
Total course time
1 day
Target group
Staff working in the field of quality
assurance, validation and production.
Practical exercises
– Sampling of airborne microorganisms in
laminar flow systems and in a demo isolator
– Sterility test handling
Total course time
2 days
Target group
This training seminar is particularly suited for
staff working in quality assurance and|or
quality control in the pharmaceutical industry.
Prerequisites
The participants must be familiar with the
basic principles of microbiology.
Training and Seminars
293
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