HOF Sonderanlagenbau now offers the HOF Massanalyzer as an integrated measuring solution based on mass spectrometry for determining specific mass spectra in the freeze-drying process.
The HOF Massanalyzer is a PC-based, multifunctional and versatile monitoring tool that is particularly suitable for detecting traces of silicone oil and monitoring steam concentrations in the vacuum process atmosphere. It is a valuable aid in quality monitoring to meet regulatory requirements for FDA GMP and the EU GMP Guide Annex I.
State-of-the-art process monitoring
Mass spectrometers are being used more and more frequently in the pharmaceutical industry because they increase production reliability and enable continuous monitoring of the production environment.
The HOF Massanalyzer is a proven solution that has already been successfully applied at HOF‘s Technical Centre, as well as multiple production Freeze-Dryers in the pharmaceutical and biotechnological environment.
The PC-based system can be installed temporarily with supplied adapters and tube segments or permanently integrated into the lyophiliser to perform a range of specific measuring tasks. These include detecting all gaseous contaminations and delivering precise data on ppm concentrations, partial pressures, and silicone contamination.
Improved quality control
The HOF Massanalyzer can be used to test for the three most common causes of process faults and system failures:
- Silicone oil detection: Silicone oil leaking into the drying chamber has an impact on the product and leads to production losses. Visual checks may confirm a leak but with no data on when it first occurred, meaning previous product batches may need to be checked retrospectively. The HOF Massanalyzer uses mass spectrometry to detect even the tiniest quantities of silicone oil inside the Freeze-Dryer, enabling early detection of contamination. This helps to prevent product loss and the associated costs. Measurements can be carried out cyclically or continuously to suit the individual production regime and the corresponding process requirements.
- Moisture monitoring: With the HOF Massanalyzer, steam and gas concentrations and moisture levels content can be monitored precisely during freezing and the subsequent drying cycles. This helps to optimise drying processes and prevent unnecessary drying times. As saturated steam is removed from the product during lyophilisation, the Massanalyzer can measure this drop accurately and correlate the measurement with the average actual product moisture. Further advantages are that the drying curve of the product can be predicted based on the moisture content and that drying progress can be compared against a benchmark “qualified batch” to confirm that the process is running as expected.
- Efficient leak testing: The HOF Massanalyzer’s very high response sensitivity can significantly cut the time needed for indispensable leak testing to prevent system contamination. Where a leak is detected, a helium test must be conducted to find the cause, and this can be started immediately where the Massanalyzer is already connected.
Versatile applications
Despite being based on advanced technology, the HOF Massanalyzer is compact, safe and easy to use in one of three different application variants:
- HOF Massanalyzer mobile: a standalone trolley mountable system that can be cable connected to plant and a laptop PC for a mobile testing station that can used with several different lyophiliser installations to generate separate test reports. Because the software is self-contained, it does not affect the lyophilisation plant operating system and therefore needs minimal qualification.
- HOF Massanalyzer smart: a standalone system that can be semi-permanently attached to a particular lyo installation, again connecting to a PC to generate reports on that location only. As before, the standalone nature of the Massanalyzer smart means it makes no interventions in the plant operating system and is therefore ‘plug and play’ with little qualification needed.
- HOF Massanalyzer integrated: a fixed location measuring/monitoring solution that is fully integrated into the overall freeze-drying plant control system and its parent software. This is a more comprehensive solution that offers quality monitoring across the whole facility with the entire system being qualified as an integrated unit.
Massanalyzer benefits
HOF Massanalyzer revolutionises the speed and ease of freeze-drying quality control with quick and ultra-precise monitoring for the most common causes of poor product quality: silicone oil contamination, incorrect moisture levels, or system leaks.
Further benefits include:
- Automatic detection within the production cycle without changing the freeze-drying process sequence.
- Low validation requirements with the main process remaining unaffected.
- Verification of the calibration and measuring sensitivity thanks to automatic calibration and function test during detection.
- Generation of a separate batch log.
- Easy servicing and maintenance, thanks to the HOF Circular Concept in which entire modules are swapped and serviced off-site.
- Comprehensive customer support, including training courses at HOF headquarters or at client site.
Click on HOF Massanalyzer to download the product flyer.