HOF MASS ANALYZER - Quality control for pharmaceutical freeze drying equipment

The use of freeze drying equipment in the pharmaceutical and biotechnology environment makes the highest demands on sterility and purity. In addition, the high value of the batches and the predetermined production process necessitate an absolutely smooth functioning. Process safety and process stability are key factors.

The company HOF has developed a process control system that is suitable for the analysis of mass spectra, in particular of trail of silicone oil and monitoring of water vapor concentrations in the atmosphere under vacuum. The HOF’ s Massanalyser is an integrated approach based on a mass spectrometer for determination of specific mass spectra in the process chamber of a freeze-drying system. The mass spectrometer is installed in a portable protection frame for safe handling on the operating site.

The PC-based system is temporarily installed. Provided adapter and hose segments therefore allow an adaptation to the specific measurement tasks. It detects all gaseous contaminants and provides a precise output signal (ppm partial pressure). This proven multi-functional system, which is already applied at the customer’s site, in the pilot plant laboratory “Technikum” at HOF and for service interventions can be flexibly used for the different freeze drying equipments.

Silicone oil detection

Silicones are suitable as heat transfer media for energy transport in and out of the process chamber, as sealing material and for surface treatment of vial sealing plug. The positive characteristics with regard to thermal stability, low viscosity and toxicity, high flash point, low vapor pressures and water insolubility are decisive points.

However, there might be some leaks in the silicone oil circuit in the form of small cracks in the piping systems due to   repetitive cycles and high temperature and pressure differences and mechanical stresses. In order to detect it in an early stage and to prevent the contamination of silicone oil in the process chamber, the HOF’s MASS ANALYZER is used. Sterile and non-sterile silicone oils can be differentiated and diagrammed on the basis of the mass number, depending on the application (see pictures, source: J. Lümkemann, Roche Ltd, G. Schilder).

Your benefits at a glance:

• Very high accuracy of the measurement system
• Monitoring of the chamber atmosphere in terms of characteristic Peak's for water vapor, oxygen, silicon oil and helium
• Optimisation of freeze drying program
• Improved plant safety and process integrity

"Quality control has top priority at HOF. Our mass analyser provides our customers with a highly efficient control system for quality monitoring.“

Alexander Hof - General Management