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Case Study: Rottendorf

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Case Study: Rottendorf
SAFELINE
Case study
Metal Detection
Rottendorf Pharma Advanced Technology
Delivers High Quality
Rottendorf Pharma GmbH is an international pharmaceutical manufacturer
that specialises in contract manufacturing. As a specialist manufacturer
of tablets and capsules Rottendorf provides its customers with a range
of services, from the development and manufacture of the product, to its
packaging and distribution; taking responsibility for the entire process
across the complete supply chain.
Rottendorf uses GMP and FDAcompliant systems and advanced
technologies such as reliable
metal detection systems from
METTLER TOLEDO to achieve this.
Tablex-PRO systems are highly
sensitive, reliable metal detection
solutions for the inspection of
tablets and capsules. The TablexPRO was developed to meet
the special requirements of
pharmaceutical production.
Each tablet produced is inspected
for metal contamination before
packaging. The Tablex-PRO is
capable of detecting ferrous,
non-ferrous and stainless steel
contaminants as small as 0.3mm,
and automatically removing
contaminated products from the
production process.
"The Tablex-PRO not only improves
the quality of our products, it also
reduces production costs thanks
to its accurate rejection process
and quick setup," explains Michael
Barton, Head of Tablets and
Coating at Rottendorf Pharma.
The Tablex-PRO can be set up
quickly for each new batch,
maximising valuable production
The Tablex-PRO from
Mettler-Toledo reliably
inspects each tablet
produced.
Case study
time. The quick setup time
is especially important for
a subcontractor like Rottendorf
Pharma, which produces up to
90 different products in a week.
Scheduled performance verification
tests are conducted before and
after each new batch of products
produced. Authorized Rottendorf
employees log on with their
individual user name and password
to perform the verification tests,
apply new settings or prepare a
batch change. This provides full
audit tracability supporting the
requirements of 21 CFR part 11.
The Tablex-PRO generates reports
with access time stamps and
employee names and provides
Michael Barton with valuable
information on all operative settings
including process times and
compliance of the processes.
Typically up to three batch
changeovers are performed in
one production day at Rottendorf
Pharma. At peak times, the
contract producer can make up to
400,000 tablets per hour. False
rejects or unnecessary downtime
can greatly impact the efficiency of
production processes, especially
Mettler-Toledo Safeline Ltd.
Montford Street
Salford
M50 2XD
UK
Tel: +44(0) 161 848 8636
Fax: +44(0) 161 848 8595
E-mail: [email protected]
Subject to technical changes
© 05/2015 Mettler-Toledo Safeline Ltd
Printed in UK
SLMD-UK-CS-EN-RPHARMA-0515 (M)
for a subcontractor like Rottendorf
Pharma.
In addition to extraordinary
operational stability and high
availability, the Tablex-PRO
metal detection solution also has
a condition monitoring function.
Unplanned downtime can be
prevented because the Tablex-PRO
system provides advanced warning
of potential problems prior to
failure. The Tablex-PRO continually
analyses the performance of its
most important components and
identifies any negative trends.
Full colour histograms are utilised
to give an early warning of any
changes in detector sensitivity,
allowing the operator time to plan
for corrective maintenance to
be completed.
All recorded metal detection data
is collected and can be accessed
via an integral Ethernet adapter,
enabling connection to the
company's factory management
system. Data can also be accessed
manually via a USB interface
for documentation purposes. All
recorded data and processes,
including electronic signatures are
captured and stored for quality
management. Thanks to the
documentation and data recording
functions, the Tablex-PRO helps
Rottendorf Pharma meet its quality
requirements in order to comply
with GMP and FDA regulations.
Automatic rejection of contaminated
products by the Tablex-PRO.
About the Company
Rottendorf have worked
in partnership with global
pharmaceutical clients for over
80 years to actively develop,
manufacture and package
pharmaceutical products in solid
dosage form. The service portfolio
of the pharmaceutical specialist
ranges from the development
of processes and formulas
to upscaling and large-scale
production.
Company headquarters in Ennigerloh, Germany.
www.mt.com/md-rottendorf
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