Freeze drying and sterilisation Laboratory
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Development of sterilisation cycles The Laboratory has a specialised autoclave which enables sterilisation of samples by the following methods: Pure dry steam sterilisation •2 – 3 day training courses for maintenance and production staff, with LYOBETA type pilot freeze drying equipment for monitoring complete processes and creating recipes, plus training on industrial equipment. •Specific courses on particular topics: programming, qualification, refrigeration, creation of recipes, optimisation of freeze drying cycles, and; special operations such as: control of the process by resistivity, in-process testing with a moisture control probe, barometric process control (BTM). Equipment and systems available in the Telstar Laboratory Autoclave Telstar Steridelta A Air counter-pressure steam sterilisation Autoclave Telstar Steridelta W Specialised training Water counter-pressure sterilisation •Lyoquest model laboratory freeze dryer •LYOBETA-25 model pilot freeze dryers. Equipped with: •PLC-based control and SCADA (supervisory control and data acquisition) system •Isolation valve between chamber and condenser •Stoppering device •Measurement of the sublimation front temperature, flow rate and other parameters by DPE (Dynamic Parameters Estimator) •Vacuum control by microbleed modulating valve •Vacuum reading in parallel with Baratron vacuum capacitance manometer and Pirani gauge •Moisture sensor in the chamber •Measurement of the temperature of the product with PT100 probes and thermocouples •Sample thief device •Cryogenic microscope •System for the rotary freezing of bottles in an alcohol bath •Resistivity control equipment •Vial filling equipment •Final moisture control by the Arizona Instruments Computrac method. •High frequency system for vacuum control in sealed bottles (non-destructive test) •Laminar flow cabinet for handling powder products. Preparation of solutions for freeze drying •Sterilisation autoclave using pure dry steam, steam-water counter-pressure and superheated water. Freeze drying and sterilisation processes R&D Laboratory Sterilisation of Client product in the laboratory’s autoclave Tests in the autoclave can determine the optimum conditions for sterilisation for all types of product: solid, porous, liquid, plastic, and so on. Product formats which usually require an in-depth study are plastic containers with liquid inside. The overpressure exerted by the gas inside the container during sterilisation may permanently deform it so as to render it unusable. The external counter-pressure which needs to be exerted throughout the process to prevent deformation of the container is determined in the laboratory autoclave. This counter-pressure may be exerted with the steam-air mixture or with superheated water. The choice of which system is most appropriate will depend upon the state in which the container is to emerge from the autoclave: dry or wet. The small volume of the autoclave chamber makes it possible to carry out tests with small quantities of containers. The results can then be easily transferred to an industrial scale plant. www.telstar-lifesciences.com 02 309 1111 I Telstar reserves the right to improvements and specifications changes without notice.

Development of freeze drying recipes Expert users may also make use of Telstar’s services to optimise elderly recipes which were designed at a time before present-day analytical methods became available. Telstar makes its Process Laboratory available to you … A preliminary study of the thermal characteristics of the product makes it possible to adjust the working conditions of the freeze dryer in order to increase the sublimation rate without compromising the final quality of the product. This may result in a considerable saving in the cycle time, with a consequent increase in productivity....

Development of freeze drying recipes Expert users may also make use of Telstar’s services to optimise elderly recipes which were designed at a time before present-day analytical methods became available. Telstar makes its Process Laboratory available to you … A preliminary study of the thermal characteristics of the product makes it possible to adjust the working conditions of the freeze dryer in order to increase the sublimation rate without compromising the final quality of the product. This may result in a considerable saving in the cycle time, with a consequent increase in productivity....

Development of freeze drying recipes Expert users may also make use of Telstar’s services to optimise elderly recipes which were designed at a time before present-day analytical methods became available. Telstar makes its Process Laboratory available to you … A preliminary study of the thermal characteristics of the product makes it possible to adjust the working conditions of the freeze dryer in order to increase the sublimation rate without compromising the final quality of the product. This may result in a considerable saving in the cycle time, with a consequent increase in productivity....

Development of sterilisation cycles The Laboratory has a specialised autoclave which enables sterilisation of samples by the following methods: Pure dry steam sterilisation •2 – 3 day training courses for maintenance and production staff, with LYOBETA type pilot freeze drying equipment for monitoring complete processes and creating recipes, plus training on industrial equipment. •Specific courses on particular topics: programming, qualification, refrigeration, creation of recipes, optimisation of freeze drying cycles, and; special operations such as: control of the process by resistivity,...

Development of sterilisation cycles The Laboratory has a specialised autoclave which enables sterilisation of samples by the following methods: Pure dry steam sterilisation •2 – 3 day training courses for maintenance and production staff, with LYOBETA type pilot freeze drying equipment for monitoring complete processes and creating recipes, plus training on industrial equipment. •Specific courses on particular topics: programming, qualification, refrigeration, creation of recipes, optimisation of freeze drying cycles, and; special operations such as: control of the process by resistivity,...