30 January, 2012 -- One of the world’s biggest pharmaceutical companies has recently embarked on a long-term evaluation programme for the LYOPLUS® mass spectrometer from GEA Lyophil to provide essential data from within the freeze dryer itself. The company has confirmed a number of benefits of the LYOPLUS® system including: the ability to detect very small silicone oil leaks inside the dryer; the ability to monitor the moisture content within the freeze drying chamber; identifying the end point of primary and secondary drying; and a much easier and faster leak detection.
The pharmaceutical company, which prefers not to be named for commercial reasons, already has a LYOPLUS® system in operation and will have the system fitted to five additional freeze dryers early in 2012. By the end of 2012 it expects to have more systems in operation.
LYOPLUS® is a mass spectrometer that is fitted with advanced software enabling it to provide much more measurement data than would be possible with ordinary equipment. 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 can lead to small leaks. As a consequence oil can contaminate the end 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 even small traces of silicone oil leaking within the dryer during the operating cycle. No additional product is at risk as the leak would have been detected immediately.
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 GEA Lyophil´s 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.
Chamber leak tests
To prevent any contamination through a 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. Using LYOPLUS® however 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®, however, is permanently connected to the system so the helium leak test can begin instantly, detecting leaks much faster thereby saving valuable time.
LYOPLUS® from GEA Pharma Systems – Lyophil™ performs all these three tests – silicone oil detection, moisture content and chamber leakage - in one single unit, thereby improving productivity; reducing power consumption and the environmental impact of the process; and finally saving the user time and money.
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For further business information contact:
Hubert Kluetsch - Director Sales and Marketing
GEA Lyophil GmbH
Kalscheurener Str. 92 50354 Huerth Germany
Tel: +49 (0) 2233/6999-220 Fax: +49 (0) 2233/6999-8220
GEA Pharma Systems unites the technologies of Aeromatic-Fielder™, Buck™, Collette™, Courtoy™, Diessel™, and Lyophil™ to provide advanced one-stop solutions for solid and liquid dosage processing to the global pharmaceutical industry.