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HOF Massanalyzer Quality monitoring of pharmaceutical freeze drying plants – meets all criteria of the EU GMP Guide Annex I … premium pharma solutions
HOF – technology Safe handling and high accuracy State-of-the-art technology for process monitoring PC-based, multifunctional and versatile measuring system Mass spectrometers are being used more and more fre- quently in the pharmaceutical industry because they in- crease production reliability and enable continuous moni- toring of the production environment. The HOF Massanalyzer is an integrated measuring soluti- on based on a mass spectrometer for determining specific mass spectra in the processing chamber of a freeze drying plant. It is particularly suitable for analysing traces of si- licone oil and monitoring the steam concentration in the process atmosphere in a vacuum. The PC-based system is installed temporarily. It can be adapted to specific measuring tasks with the supplied ad- apters and tube segments. It detects all gaseous contami- nation and delivers a precise output signal (ppm, partial pressure). This multifunctional system is already a proven system, successfully used at the customer´s, at HOF‘s tech- nical centre and at maintenance visits and can be applied in different freeze-drying plants. 2
Precise, efficient and flexible The HOF Massanalyzer focuses on three test methods: Product safety through silicone oil detection for optimised drying processes Silicone oil leaked into the drying chamber has an impact on the product and leads to production losses. If a leak is detected with a visual check, it is usually no longer possible to determine when the silicone oil first leaked and consequent- ly several product batches have to be examined. The HOF Massanalyzer uses mass spectrometry to detect even small quantities of silicone oil inside the dryer, enabling early detection of contamination. This helps to prevent product loss and the associated costs. Whether measurements are carried out cyclically or continuously depends on the respective production concept and the corresponding process requirements. Precise moisture monitoring for optimum drying processes With the HOF Massanalyzer, moisture and moisture content can be monitored precisely. Thanks to its high level of flexibility, the mass spectrometer can also be used to monitor the steam concentration and other occurring gases. This helps to optimise drying processes and prevent unnecessary drying times. The system also enables monitoring of the moisture level during the drying cycle. In the beginning, saturated steam is used, which is quickly removed from the product. The moisture level reduces significantly later on during the drying process. The HOF Massanalyzer measures this drop accurately and correlates the measurement with the average actual product moisture. This information helps to refine the drying processes and minimise unnecessary drying times. Another advantage is that the drying curve of the product can be predicted based on the moisture content. The drying progress of each batch can be compared with a “qualified batch” to confirm that the process is running as expected. Efficient leak testing for optimum system integrity The HOF Massanalyzer makes it possible to significantly shorten the time for leak testing after critical tests or sterilisation. This test is indispensable for preventing contamination due to leaks in the system. The HOF Massanalyzer can be used to run leak tests for preventing all contamination due to leaks in the system. This stan- dard procedure can take some time depending on the type. The very high response sensitivity of this device, however enables a significant reduction of the duration of this test. If a leak is found during a test, a helium leak test has to be conducted to find the cause, which can take some time if external standard equipment is used. As the system is permanently connected, a helium leak test can be started immediately, to save precious time and detect leaks more quickly. 3
HOF – technology Highly precise, absolutely reliable and flexible The HOF Massanalyzer is a highly precise and reliable me- asuring device. Based on an advanced technology, it enables easy and ef- fective process monitoring. A special focus was placed on safe handling and high performance. The versatile measuring device can be run independently or integrated seamlessly into existing control systems without impacting the active process. The proven multifunctional system can be used flexibly on different freeze drying plants. Three application variants are available. 4
HOF – technology Multifunctional measuring system for more safety in production HOF offers three application variants for the HOF Massanalyzer: HOF Massanalyzer mobil HOF Massanalyzer smart HOF Massanalyzer integrated 1 device for several lyos short connecting short connecting cable cable not integrated into the process not integrated into the process fully integrated into the process HOF Massanalyzer mobile used for several lyos minimum qualification effort due to no intervention in the lyo software separate PC and test report HOF Massanalyzer smart stationary version with own software minimum qualification effort due to no intervention in the lyo software HOF Massanalyzer integrated stationary version with software link to the freeze drying plant fully integrated into the sterilisation process sequence or plant self-test 5
HOF – technology Efficient maintenance with HOF Service+ As a mass spectrometer like the HOF Massanalyzer is a highly sensitive measuring device, it is advisable to service the system regularly. HOF recommends to replace at customer‘s especially the sensitive components as an assembly using a circular con- cept and then having these cleaned/refurbished and che- cked at HOF according to the manufacturer‘s instructions. This procedure ensures short maintenance periods, ensuring fast availability of the system for production. For the circular replacement concept, complete assemblies are replaced and then re-installed during the next main- tenance. HOF offers a starter package for maintenance to ensure that the assembly always remains with the customer and that the most important assemblies are always available. For the circular replacement concept, assemblies are changed as a whole. Fast availability after maintenance. HOF offers a starter package for ensuring that the assembly remains with the customer. We also see the additional advantage of a short maintenance period on site. Overview of services Measurements with mobile devices at the customer site Maintenance/repair of RGAs to manufacturer’s specifications by trained qualified personnel Training courses at the HOF factory or on site Measuring of the background contamination for specification in production 6
Benefits at a glance The HOF Massanalyzer: Efficient product safety with optimum process monitoring Optimum detection of silicone oil Automatic detection with integration into the Precision moisture monitoring Effective leak testing turnaround without changing the process sequence of the FD Low validation effort as the main process remains unaffected Verification of the calibration and measuring sensitivity thanks to automatic calibration and function test during detection Generation of a separate batch log Optimum service and maintenance products Reliable customer support The HOF Massanalyzer meets all criteria of the EU GMP Guide Annex I, offering the required reliability for easy and efficient quality monitoring. 7
HOF Sonderanlagenbau GmbH Freeze Drying Systems | Loading and Unloading Systems | Freeze-Thaw Units | Waterbath and Debottling Systems | Service Headquarters: Ludwig-Rinn-Str. 1–3 | 35102 Lohra | Germany Mornshausen site: Vor dem Langen Loh 2 | 35075 Gladenbach-Mornshausen | Germany Phone +49 6462 9169-0 | Fax +49 6462 9169-199 info@hof-sonderanlagen.de | www.hof-sonderanlagen.de Headquarters Lohra Mornshausen site premium pharma solutions