LYOPLUS Multipurpose Measurement Device for pharmaceutical Freeze Dryers0 pages

GEA Lyophil LYOPLUS™
Multipurpose measurement device
for pharmaceutical freeze dryers
LYOPLUS™ is a mass spectrometer that is fitted with advanced software
enabling it to provide multiple process and equipment measurement data.
The system is able to work alongside any existing PLC/SCADA system as a
stand alone unit or fully integrated within the control system. It can also be
operated independently as a monitoring system that does not interfere with
any qualified processes.
Silicone oil detection
Top of the list of system benefits is its unique ability to detect very small traces of
silicone oil within the dryer. Silicone oil is used to transfer the required heat energy to
the product. After years of operation and many cycles the arduous conditions within
the dryer could lead to small leaks. As a consequence oil can contaminate the final
product.
After the leak in the circulation system has reached a certain size this contamination
will be detected during end product testing in quality control. That particular batch
is of course lost but additionally suspicion immediately rises about the purity of
previous batches.
Using LYOPLUS™, however, it is possible to detect very small traces of silicone oil
leaking within the dryer during the operating cycle. No additional batches are at risk
as the leak would have been detected immediately.
 
Moisture content
The LYOPLUS™ system can also monitor moisture levels within the drying chamber
during the drying cycle. At the beginning of the drying process the chamber
will be filled with a saturated water vapour as water is removed rapidly from
the product. During the later stages, however, the moisture level in the chamber
reduces significantly. LYOPLUS™ measures this drop very accurately and correlates
the measurement with the actual average product moisture inside the vials. This
information can be used to refine drying recipes and avoid any unnecessary drying
time. One of our customers has reported a three-hour saving per cycle providing
improved productivity and a reduction in power consumption.
An additional benefit comes from being able to predict the drying curve of the product
through the moisture content in the chamber. Drying behaviour for each batch can be
compared with a ‘qualified batch’ to confirm that the process is progressing normally.
Technical data:
Fully automated
Fail-safe operation to protect sterility, the lyophilization
equipment and the measurement device
Standalone or optional full SCADA Implementation
High performance quadrupole mass spectrometer system
Mass range: 1-100 standard
(1-200 AMU or 1-300 AMU optional)
High conductance inlet system
Max. operating pressure: 1 mbar
Detection limit: 1ppm of non-interfering species

engineering for a better world

Chamber leak tests
To prevent any contamination through a vacuum leak in the system, it is mandatory
to perform a leak test after each critical process, i.e. after sterilization. This can take up
to four hours, depending on the type of test performed, causing loss of productivity
and consuming additional energy to create the necessary test conditions. By using
LYOPLUS™ it is possible to reduce the time for this standard procedure down to
approximately one hour owing to its very high sensitivity.
If during the test a leak is detected it is necessary to perform a helium leak test to find
the source of the leakage. Using standard external equipment for helium leak testing
sometimes takes several hours to set up; LYOPLUS™ is permanently connected to the
system so the helium leak test can begin instantly, detecting leaks much faster thereby
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