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Freeze drying and sterilisation Laboratory

Freeze drying and sterilisation Laboratory

Freeze drying and sterilisation Laboratory

Product catalog summary
Overview of Telstar Laboratory Equipment and Systems
The Telstar Laboratory is equipped with advanced freeze drying and sterilization systems, including the Lyoquest model laboratory freeze dryer and LYOBETA-25 model pilot freeze dryers. These systems feature PLC-based control, SCADA systems, and various measurement and control devices to ensure precise freeze drying processes.
Freeze Drying Equipment Features
  • Isolation valve between chamber and condenser
  • Stoppering device
  • Dynamic Parameters Estimator (DPE) for measuring sublimation front temperature and flow rate
  • Vacuum control via microbleed modulating valve
  • Parallel vacuum reading with Baratron vacuum capacitance manometer and Pirani gauge
  • Moisture sensor in the chamber
  • Temperature measurement with PT100 probes and thermocouples
  • Sample thief device
  • Cryogenic microscope
  • Rotary freezing system for bottles in an alcohol bath
  • Resistivity control equipment
  • Vial filling equipment
  • Final moisture control using the Arizona Instruments Computrac method
  • High frequency system for non-destructive vacuum control in sealed bottles
  • Laminar flow cabinet for handling powder products
Sterilization Processes and Equipment
The laboratory features a specialized autoclave for sterilization using pure dry steam, steam-water counter-pressure, and superheated water. This allows for the optimization of sterilization cycles for various product types, including solid, porous, liquid, and plastic containers.
Development and Optimization of Freeze Drying Recipes
Telstar provides services for the development and optimization of freeze drying recipes. This includes analyzing product thermal characteristics, determining critical temperatures, and optimizing freeze drying cycles to improve product quality and productivity.
Training and Consultancy Services
Telstar offers specialized training courses for maintenance and production staff, focusing on monitoring complete processes and creating recipes. They also provide consultancy services for the development, qualification, and validation of freeze drying and sterilization cycles.
Compliance with Manufacturing Regulations
All processes adhere to Good Manufacturing Practice (GMP) standards, ensuring that medicines are qualified and prepared according to regulatory requirements.
Overview
The document outlines the capabilities and services of the Telstar Life Sciences R&D Laboratory, focusing on freeze drying and sterilisation processes. It highlights the laboratory's equipment, sterilisation methods, and training programs.

Sterilisation Processes
The laboratory is equipped with a specialised autoclave that allows for the sterilisation of various product types, including solids, porous materials, liquids, and plastics. A key focus is on plastic containers with liquids, where the internal gas pressure during sterilisation can cause deformation. The laboratory determines the necessary external counter-pressure to prevent this, using either a steam-air mixture or superheated water, depending on whether the container should be dry or wet post-process.

Equipment
The laboratory features advanced equipment such as the Lyoquest model laboratory freeze dryer and LYOBETA-25 model pilot freeze dryers. These are equipped with PLC-based control, SCADA systems, and various measurement and control devices, including vacuum control systems, moisture sensors, and temperature probes. Additional equipment includes a cryogenic microscope, resistivity control equipment, and a laminar flow cabinet.

Training Programs
Telstar offers 2-3 day training courses for maintenance and production staff, focusing on the use of LYOBETA type pilot freeze drying equipment and industrial equipment. Specific courses cover topics like programming, qualification, refrigeration, recipe creation, and freeze drying cycle optimisation. Special operations training includes process control by resistivity, moisture control probes, and barometric process control.

Conclusion
The Telstar Laboratory provides comprehensive services and training for sterilisation and freeze drying processes, supported by state-of-the-art equipment and specialised training programs.
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Catalog excerpts

Freeze drying and sterilisation Laboratory-1

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.

 Open the catalog to page 1
Freeze drying and sterilisation Laboratory-2

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. Current...

 Open the catalog to page 2
Freeze drying and sterilisation Laboratory-3

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. Current...

 Open the catalog to page 3
Freeze drying and sterilisation Laboratory-4

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. Current...

 Open the catalog to page 4
Freeze drying and sterilisation Laboratory-5

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...

 Open the catalog to page 5
Freeze drying and sterilisation Laboratory-6

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...

 Open the catalog to page 6

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.