STER ILIZ AT IO N

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Experience and modern technology –
a winning combination
Transcoject has been a reliable partner in the ethylene oxide
sterilization of thermo-sensitive products for the medical and
pharmaceutical industries for over 40 years. We have sterilized
using a dual-chamber system, each with a volume of 33 m3, in
various cycles according to ISO 11135-1 for the past decade.
Our experienced team of experts advise and assist our customers
through the individually tuned sterilization cycle right up to
product sterilization. This also includes the microbiological testing
in our in-house laboratories.
We remain at your disposal with our wide range of individual
services, from concept development to market launch as a fullservice partner in the ethylene oxide sterilization
STERILIZATION
TRA10004_PB_Sterilization_eng:Layout 1
TRA10004_PB_Sterilization_eng:Layout 1
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Process
Development
Sampling
and Testing
Validation/
Revalidation
Transcoject
Sterile Solutions
Logistic
Services
Sterilization
Laboratory
Services
Process Development
The properties and features of a product requiring sterilization
often call for the development and employment of specific
sterilization cycles.
Sterilization
Our expert team advise and support our customers in process
development and routine sterilization as well as in selecting optimal solutions regarding both quality and economics.
The ethylene oxide sterilization is performed in different cycles and rests on a comprehensive quality assurance system in
accordance with current legislation and
standards.
Validation / revalidation
Additional laboratory services
We define the scope of the pending work packets and assist in the
execution of all stages right up to and including the entire implementation of the validation according to DIN EN ISO 11135-1 in
close dialogue with our customers.
Due to maintaining our own laboratory, we
are in the position to offer a variety of
additional services, such as bio burden or
residual gas examinations as well as seal
integrity tests.
Logistics
A comprehensive offer of logistic services
rounds off our range. Whether new palletising, commissioning or shipping – even in
this area, we facilitate corresponding
services for our customers, which we gladly
adapt to fit individual wishes.
Special services
We offer solutions at the highest level of
quality to enable our partners to realise
their tasks in a fast and cost-effective
manner, whether it is the development or
testing of alternative packaging or carrying
out sampling.
Transcoject GmbH
D-24539 Neumünster, Rügenstraße 8
Fon +49 4321 885-0 • Fax +49 4321 885-65
www.transcoject.com • info@transcoject.com
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