Freeze-drying service laboratory

					                                             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.
                                                                 ? 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
? 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
    - 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


                                                                 01 309 1208 E Telstar reserves the right to improvements and specifications changes without notice.