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Development and optimization recipe

Telstar’s equipment and knowledge allow us to determine the most suitable recipe parameters for the customer’s product, ensuring an efficient production of high-quality products without defects on cosmetics, packaging, or problems with decontamination.

Freeze Drying

The freeze-drying process, also known as lyophilization, is possibly the mildest drying technique for pharmaceutical products. Even though freeze drying is a well-known technology, it is always evolving. The main challenges that the industry is facing can be categorized in two well-differentiated areas: maintaining the asepsis of the drug manufacturing chain; and, optimizing the process to enhance as much as possible the operational efficiency, but maintaining the critical quality attributes (CQAs) of the final product.

The study of the thermal characteristics of the product makes it possible to adjust the working conditions of the freeze dryer 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.

The determination of the product’s thermal characteristics is the first study to perform through Differential Scanning Calorimetry (DSC) and Freeze-Drying Microscope (FDM). Both techniques allow knowing the critical product temperatures to correctly set the critical process parameters (CPPs). It is also possible to evaluate the potential benefits of heat treatment or annealing during the product freezing process.

  • Te Eutectic temperature
  • Tg’ Glass Transition Temperature
  • Tc Collapse temperature
  • Recrystallisation temperatures

Once the product is known, different freeze-drying cycles are developed in which the optimisation of the freeze-drying cycle is analyzed together with the study of the following critical quality attributes of product (CQA’s):

  • Residual moisture measurement (%HR).
  • Reconstitution time.
  • Cosmetics of product.

Computrac is a residual moisture analytical tool, which together with the sample thief of freeze driers allows Telstar to design the desorption curve and to adjust secondary drying durations. Telstar’s process laboratory uses Process Analytical Technology (PAT) tools to determine the customer’s product   parameters, such as the pirani/capacitive manometer, thermocouples, and PT-100, Lyometrics (soft-sensor to monitor the sublimation front product temperature), pressure rise test (PRT) at primary and secondary drying, among others. Telstar’s controlled nucleation system known as “Lyonuc” can also help to improve homogeneity, cosmetics, and cycle total durations.

Moist heat sterilization

Sterilization is a fundamental step in the manufacturing process to kill any microorganisms on change parts, manufacturing materials or final product, to ensure pharmaceuticals and biopharmaceuticals are safe to use. Moist heat is the preferred sterilization method to be used whenever possible on products that are heat and moisture resistant. There are three different moist heat sterilization methods:

  • Saturated steam sterilization.
  • Steam and air mixture sterilization.
  • Super-heated water sterilization.

The autoclave in Telstar’s process laboratory can perform the three different types of processes, and the tests in the autoclave can determine the optimum conditions for sterilisation for all types of products: solid, porous, liquid in open or closed containers, and so on.

An example of development could be the terminal sterilization of liquid product in closed plastic containers. The overpressure exerted by the liquid and the air inside the container during sterilisation may deform it permanently.

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 many factors, as for the state in which the container is to emerge from the autoclave: dry or wet.

Various investigations, such as terminal sterilization, sterilization of products in Tyvek bags, bottles, vials, syringes, and other containers, can be conducted. The small volume of the autoclave chamber makes it possible to carry out tests with small quantities of containers or materials. The results can then be easily transferred to an industrial scale plant.

Hydrogen peroxide decontamination

Hydrogen peroxide as a sterilant is becoming a standard in aseptic facilities where sterile products are manufactured. The use of this chemical is different depending on the application and/or technology. At Telstar, as well as being experts in aseptic equipment manufacturing, we have become experts in the application of complex chemical technology in a diverse range of environments. Therefore, from the Process Laboratory we are capable of developing and optimizing existing decontamination cycles considering factors such as load, penetration in the load, distribution, in different equipment. From Safety Access Systems (SAS) to isolators or clean rooms, our expertise can assist you in the appliance of this sort of technology.

Our equipment include:

  • Dragger sensor
  • Micro-condensation sensor
  • Biological indicators
  • Chemical indicators
  • Standard SAS or isolator (to be confirmed upon order)

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