| product support |
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| The following product related support can be viewed
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Bacterial Challenge & Correlation to
Integrity Test Data For Sterilising Grade Pharmaceutical Air &
Liquid Filters
Since the early 1900’s, when the first parenteral drugs were
manufactured in large scale, Sterilising grade filters have been used
as part of aseptic processes for sterilisation of products unsuited
to terminal sterilisation such as autoclaving. These products include
heat sensitive compounds, blood products etc. more>> |
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Product Traceability
The traceability of components, assembly processes and associated
records used in the manufacture of pharmaceutical grade products is
a fundamental requirement of quality management systems such as ISO
9001 and principles defined within cGMP guidelines and associated
European Directives and FDA Regulations 21CFR 210 & 211. more>> |
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Chemical Compatibility Testing Methodology
Cartridge filters are designed for use within a wide range of applications
and will come into contact with many chemicals that are either being
filtered in their own right or are used to supplement the overall
process. As well as using a cartridge filter to purify a fluid, its
ability to be cleaned whilst in situ within its housing (cleaned in
place – CIP) is a desirable option for many users. more>>
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Biocompatibility Testing of Materials
Verification of the biocompatibility of filter products used in the
pharmaceutical processing industry is vitally important component
of product validation. To ensure that final produced drug safety cannot
be compromised under the worst case situation, materials of construction
coming into contact with the filtered solution must be tested for
biological safety. more>> |
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Steam In Place
The ability of a cartridge filter to be sterilised in situ within
its housing represents a significant operational advantage for many
filter users. Steam in place (SIP) avoids the need to use chemical
sanitising agents or to compromise the integrity of the filtration
installation, minimises operator hands on time and plant downtime
and can be easily incorporated into automated production facilities.
To achieve reproducible sterilisation conditions (typically a minimum
of 121°C for 30 minutes) and to avoid damage to the installed
filter cartridge(s), it is important to carefully design and monitor
SIP procedures. Factors including steam temperature and quality, condensate
removal, differential pressure and cooling cycles need to be considered.
more>>
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