Freeze-drying service laboratory Experts in Freeze-Drying Good practice for the pharmaceutical industry includes the know-how and manufacture of drugs according GMP's, and following all recommendations from the regulatory authorities. This means that standardised working procedures are advisable in order to ensure that every step of the manufacturing process is perfectly understood and reproducible. Telstar's team of technicians and specialists offer a complete Advisory Service for the development, qualification and validation of product freeze-drying cycles. Telstar's specialists Freeze-Drying Service Laboratory offers to study the most appropriate recipes, performing all necessary tests to be fully acquainted with the product prior to freeze-drying, determining the optimal parameters for the freeze-drying cycle and performing final quality control testing. The Telstar Freeze-Drying Laboratory Service provides valuable advice for new freeze-drying users and considerable savings in development time for the expert users, thus facilitating evaluation of the product behaviour prior to the freeze-drying process, also process adaptation and optimisation prior to its full-scale production implementation. Telstar experience and abilities in freeze-drying ensure that you will obtain the best results. Complete Study to be Performed in a Product Product analysis prior to and following Determination of the necessary parameters to freeze-drying. develop a product freeze-drying recipe. ? Determination of the thermal characteristics of the product: The following parameters must be met to ensure that a freeze-drying operation is satisfactorily completed: - Solvent freezing point: melting point. ? Complete product freezing, assuring its perfect rigidity, - Te Eutectic Temperature of Solution TEU. Eutectic avoiding denaturation, cryoconcentrations and chemical melting point in crystalline materials, measured by ER alterations. Study of the freezing speed. (Electrical Resistance). Eutecticmeter. ? Determination of the temperature and pressure - T’g Glass Transition Temperature, measured by DSC parameters in the primary drying for complete ice (Differential Scanning Calorimeter) in both crystalline sublimation. and amorphous products. ? Determination of the primary drying end point in order to - Tc Collapse Temperature, detected in the Cryogenic shift to secondary drying. Microscope. ? Determination of the temperature and pressure These tests allow identification of the critical temperature parameters in the secondary drying that allows the for the freeze-drying process. They are also useful in elimination by desorption of the residual adsorbed water. deciding if there is a requirement for thermal treatment of the product during its freezing stage. ? Final conditioning of the freeze-dried product, protecting it from moisture, oxygen, light and, if necessary, ? Residual Moisture Control (% HR). stoppering it under vacuum or in a controlled ? Leak testing on vacuum stoppered vials: final vacuum test atmosphere. with High Frequency tester. This is a none destructive test. Special training. ? 2 - 3 days special training for maintenance and production personnel, using LyoBeta pilot equipment to follow-up complete processes and the creation of recipes. Training with industrial equipment is also available. ? Specific courses on specific subjects: programming, qualification, refrigeration, creation of recipes, optimisation of the freeze-drying cycles, special operations such as: resistivity process control, test with in-process humidity control probe, barometric control of the process (BTM). Cryogenic Microscope Equipment available at Telstar Laboratory. ? Bench top laboratory freeze-dryer, 4 l, model Telstar LyoQuest. ? Pilot plant freeze-dryer to carry out freeze-drying runs, 35 l ice condenser capacity, model Telstar LyoBeta 25, equipped with: - Stoppering device. - PLC control and SCADA software for control and data acquisition. - Isolation valve between chamber and condenser. - Barometric Temperature Measurement for sublimation surface temperature measurements. - Pirani and Capacitance vacuum sensors. - Moisture Sensor in the freeze-drying chamber. - Eutecticmeter. · - Several kinds of temperature sensors: PT100 and Thermocouples. ? Rotating freezing bath for flasks. ? Resistivity tester. ? DSC System. ? High speed freezing system with LN2. ? Vial filling machine. Pre-stoppering. Cap sealing. ? Residual moisture measurement tests with the Computrac equipment. ? Leak tester for vials. ? Telstar laminar flow bench for sterile handling of samples. Josep Tapiolas, 120 08226 Terrassa (Spain) T. +34 937 361 600 F. +34 937 859 342 www.telstar-lifesciences.com 01 309 1208 E Telstar reserves the right to improvements and specifications changes without notice.