Freeze drying process development software

Our freeze drying equipment is used for applications ranging from process development for scaleup to product processing for stability studies to formulations work. Passage freezedrying is a computer program designed for the simulation of freeze drying processes in vials and pans passage freezedrying. Freeze drying is a food preservation method which removes all liquid from a particular food without impacting the taste its a twostep process which starts by freezing your food. Understanding heat and mass transfer operations and how to optimize these for best results. You can store a freeze dried meal for years and years, and then, when youre finally ready to eat it, you can completely revitalize it with a little hot water. Traditionally, a commercial scale lyophilization process is developed by an. How to build quality in the freeze drying process epm magazine. Primary drying begins when you start your freeze dryer and vacuum pump. Autodry generates initial freeze drying parameters based on the critical product temperature and the solid content, including the freezing cycle, primary drying vacuum level and shelf temperature, and. Powerful software utility for modelling freeze drying cycles sp. Freezedrying process optimization pharmaceutical technology. Freeze drying, which is also known as lyophilization, is the process of removing water from a product by freezing it then subliming the ice to vapor.

Lyophilization and freeze drying are terms that are used interchangeably depending on the industry and location where the drying is taking place. Food industry food needs to be preserved by freezedrying for consumption by individuals in the. Development of simplified models for the freezedrying process and investigation of the optimal operating conditions. Freeze drying is a method for carefully extracting moisture from products like food or serums. The basics lyophilization, defined as a freezedrying process that removes water from a product after it is frozen and placed under a vacuum, is often messy, but filled with possibilities for potential applications. Freezedrying, also known as lyophilisation, lyophilization, or cryodesiccation, is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport. Autodry generates initial freeze drying parameters based on the critical product temperature and the solid content, including the freezing cycle, primary drying vacuum level and shelf temperature, and secondary drying shelf temperature and length. Freeze drying is the removal of ice or other frozen solvents from a material through the process of sublimation and the removal of bound water molecules through the process of desorption. In the subsequent primary drying phase, the chamber pressure is reduced to induce sublimation of the frozen solvent see figure 1. Freezedrying using lyostar ii dryer and sublimation rate measurements using. Finite element method fem modeling of freezedrying. The lyophilization process lends itself to accurate modeling for the following reasons. Frontiers detection of collapse and crystallization of. With the low pressure environment, evaporative cooling of the sample begins, allowing for energy in the form of heat to.

Just like evaporation, sublimation occurs when a molecule gains enough energy to break free from the. Kisialiou yury freeze drying is widely used in the pharmaceutical industry to stabilize drug products. Pdf emerging freezedrying process development and scaleup. Process recipes are input into the dryer and the user initiates the freezedrying cycle, from this point the process runs without operator intervention to apply this technology. Digital design of robust lyophilization processes innovative software and consulting for scaleup and optimisation of freeze drying processes gproms formulatedproducts lyophilization process models. An interactive tool for the optimization of freezedrying cycles. Feb 23, 2011 freeze drying in these novel container systems poses a unique challenge to freeze drying process development and scaleup. Process design begins with a robust formulation that has the most accommodating physical properties before, during and after the freeze drying process. Lyostat freeze drying microscope biopharma technology. Process optimization in the lyocapsule using innovative pat. Innovative software and consulting for scaleup and optimisation of freeze drying processes. Glass vials are widely used and are well characterized in terms of. In a typical freeze drying cycle, a product is placed in vials and dried on a shelf in a freeze dryer by first lowering the temperature sufficiently to ensure that the product is completely frozen. This freeze drying process proved to be able to produce freeflowing powder from a single vessel.

During freezedrying, solvent is removed from a frozen product by. A significant comparison between collapse and glass. Freeze drying results in a high quality product because of the low temperature used in processing. Lyophilization or freeze drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without. The most frequently used methods to determine these values are differential scanning calorimetry dsc and freeze drying microscopy fdm. Freeze drying technology, low temperatures, longer shelf life. Lyophilization freeze drying process passage freeze. You can store a freezedried meal for years and years, and then, when youre finally ready to eat it, you can completely revitalize it with a. Understanding heat and mass transfer operations and how. Freeze drying works great for fruits and vegetables, but unlike other options, it also perfectly preserves meat, fish, dairy, eggs, ice cream, and even fully. It dries out almost 98% of the water content while retaining the freshness, colour and aroma of the products.

Laboratory and pilot freeze dryers advanced processes pragolab. Lyophilization process freeze drying process passage freezedrying software is a finiteelement modeling software aimed at assisting the user and designer of freezedrying processes in improving the quality of freeze dried products in pharmaceutical, chemical and food processes. In a typical lyophilization process, the drying consists of a primary drying step, in which low pressure provides the driving force for frozen water in the product to start subliming. With the low pressure environment, evaporative cooling of the sample begins, allowing for energy in the form of heat to speed the freeze drying process. Kisialiou yury freezedrying is widely used in the pharmaceutical industry to stabilize drug products. Freezedrying in these novel container systems poses a unique challenge to freezedrying process development and scaleup. At the end of primary drying, roughly 93% of the water in the sample is sublimated out. Known as active freeze drying afd, the new process used continuous motion to improve mass transfer and hence cutting processing time, while also eliminating the need to transfer to and from drying trays and downstream size reduction devices. You can store a freezedried meal for years and years, and then, when youre finally ready to eat it, you can completely revitalize it with a little hot water.

The challenges of formulation, cycle development and containerclosure selection webinars. However, there are few reports in the literature describing heat and mass transfer for freeze drying in. It comes with an additional overview about technical aspects to be considered and gives an overview about current technologies available on the market. Freeze drying microscopy fdm was established in the 1960s as a technique for identifying critical formulation parameters and is the only method for reliably determining collapse. Tdlasbased smart freeze dryer process development technology. Process design begins with a robust formulation that has the most accommodating physical properties before, during and after the freezedrying process. The fundamental principle in freezedrying is sublimation, the shift from a solid directly into a gas. An industry perspective on the application of modeling to. The freeze cycle can be a simple ramp or include an annealing cycle. An innovative method known as freeze drying is used to process and preserve a whole range of food products. Nov 20, 2015 lyophilisation freeze drying is a multistage process with different risks present at each stage. With 60 years of experience in the engineering and manufacturing of freeze dryers, gea has delivered more than installations and conducted thousands of freeze drying tests for the. Applications of freezedrying the process of freezedrying can be employed in the following fields 9 1.

Pdrys was developed to simulate the primary drying process, based on the. Freeze drying, also known as lyophilisation or cryodesiccation, is a low temperature dehydration process that involves freezing the product, lowering pressure, then removing the ice by sublimation. Once the food is frozen, it goes through a vacuum cycle. Pdf although several guidelines do exist for freezedrying process development and scaleup, there are still a number of issues that require. Our topnotch freezedrying equipment offers a seamless lyophilisation process for research and development of novel therapeutics. The conditions under which the process takes place will determine the quality of the freeze dried product. Typical cycle development involves calculating a trial cycle from critical temperature data and then evaluating and refining the cycle over a series of runs based on detailed analysis. Freeze drying process models have recently gained ground in the industrial setting, using both generalpurpose cfd and applicationspecific software koganti et al. Freezedrying, or lyophilization, is like suspended animation for food. Sublimation is a physical phenomenon by which solid ice is converted directly into vapor without it passing through the liquid state. Food industry food needs to be preserved by freezedrying for consumption by individuals in the fields of space exploration, hikers, military personnel, as well as the availability of dehydrated foods such as noodles, soups, etc.

Oct 23, 2019 our topnotch freeze drying equipment offers a seamless lyophilisation process for research and development of novel therapeutics. Digital design of robust lyophilization processes innovative software and consulting for scaleup and optimisation of freeze drying processes gproms formulatedproducts lyophilization process models allow for efficient design and operational enhancements for drying heat sensitive products at low temperature. Freeze drying works by freezing the material, then reducing the pressure and adding heat to allow the frozen water in the material to sublimate. Building upon over 50 years of freezedrying experience, the lyos 2. Suitable parameters of process application allow us to obtain best quality products compared to products dried with traditional methods. Noninvasive monitoring of critical product and product parameters, such as product interface temperature, temperature at the bottom of the vial, product resistance and mass flow rates in user pre. Passagefreezedrying provides modeling of containers with axisymmetric boundary conditions with both primary and secondary drying simulation capabilities.

Sp scientific announces the introduction of the lyomodelling calculator lmc a powerful new software utility that enables those developing freeze drying. Emerging freezedrying process development and scaleup issues. Glass vials are widely used and are well characterized in terms of heat and mass transfer during freeze drying 12. Freeze drying microscopy fdm was established in the 1960s as a technique for identifying critical formulation parameters and is the only method for reliably determining collapse temperatures. How to build quality in the freeze drying process epm. Even after all those years, the taste and texture will be pretty much the same. The collapse temperature tc and the glass transition temperature of freezeconcentrated solutions tg as well as the crystallization behavior of excipients are important. Endless control anywhere, anytime of your freeze drying process due to interface, software and app. This is in contrast to dehydration by most conventional methods that evaporate water using heat. Lyostar 3 process development freeze dryer lyophilizer. Freezedrying is a method of removing water by sublimation of ice crystals from frozen material. Rapid freezedrying cycle optimization using computer programs. New control system launched for development to production.

In order to select the optimum drying temperature, it. Lyophilization is common, but cost intensive and hence one of the key objectives during freeze drying process development is to minimize the drying time mainly primary drying time, which is the. Development sciences cycle design refinement lyophilization technology, inc. In order to be suitable for the design and scaleup of a freeze drying cycle, a mathematical model should reliably describe the dynamics of the process, the time required by calculations should be short, and model parameters should be few and easy to be measured. Optimization of the freeze drying process ta instruments. Windowsbased software lpc32 lyophilization process control for pc process. Lyophilization cycle development, freeze and annealing. Design space development for lyophilization using doe and. This cycle will take all the ice crystals which formed during freezing and turn them into vapor. Lyophilization webinars lyolearn webinars sp scientific.

In this process, the moisture content of the product is reduced to such a low level that does not support biological growth or chemical reactions which. Some important aspects to be considered during the freeze drying process are as follows. The freeze drying theory and process things to consider ellab. In order to select the optimum drying temperature, it is necessary to understand the physical characteristics of the components used in the formulation that is to be freeze dried. In the past, the lyophilization process was largely developed through. Equipment capability of freeze dryers and relevance to graphical design space for primary drying. Advanced models, validated against process data, enable users to reduce experimentation. Our product portfolio is ideal for continuous, reproducible lyophilisation of water and organic solvents. Understanding the critical issues in scaleup or cycle transfer. Equipment capability of freezedryers and relevance to graphical design space for primary drying. Autodry technology freeze drying millrock technology, inc.

During freeze drying, solvent is removed from a frozen product by sublimation to produce a dry product that can be readily reconstituted to its original liquid formulation by the addition of solvent. Rational freezedrying process design is based on a representative and accurate measurement of the critical formulation temperature. It dries out almost 98% of the water content while retaining the freshness, colour and aroma. The freeze drying process mainly involves 3 stages like freezing, primary drying and secondary drying. In lyophilization, or freeze drying, there is a water is frozen, followed by its removal from the sample, initially by sublimation primary drying and then by desorption secondary drying. The fundamental principle in freeze drying is sublimation, the shift from a solid directly into a gas. Line of sight range freezedrying experts sp scientific. Freeze drying of a liposome formulation results in an elegant dry cake, which can be reconstituted within seconds to obtain the original dispersion, that is, if the appropriate excipients are used and if suitable freeze drying conditions are applied.

Identifying and understanding the different stages of a freeze drying process. Freeze drying, or lyophilization, has become an accepted method of processing sensitive products that require long. The highest level of research and development for new. Freezedrying, also known as lyophilisation, is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport. Freeze drying lyophilisation of pharmaceuticals anthony. Quality by design lyophilization freeze drying process. In the food industry, the product most commonly subject to freezedrying is coffee, as the process makes it instantly soluble. Identifying and understanding the different stages of a freezedrying process. Other methods of preservation, such as canning and dehydrating, use high temperatures that destroy much of the food value. Synthite uses freeze drying technology to deliver application specific products to our clients around the world. Monitoring routine pharmaceutical freeze drying with tdlas.

Some important aspects to be considered during the freeze. Lyovapor l200 the compact lyovapor l200 offers efficient freeze drying 6 kg, 55 c with the infinitecontrol for easy process control and process monitoring from anywhere, at anytime. The software also handles containers with asymmetric boundary conditions, as in the case of vials placed in corners or near the walls of freeze. This workshop will give a thorough introduction into the physics and thermodynamics of freeze drying. Today we present what may be the most innovative area of endeavor within our company. Jan 26, 2018 the collapse temperature tc and the glass transition temperature of freeze concentrated solutions tg as well as the crystallization behavior of excipients are important physicochemical characteristics which guide the cycle development in freeze drying. Freeze drying maintains 97% of the nutritional value of the food. Such products are sensitive to temperature and care has to be taken in order to protect their internal.

Smart freeze drying technology smart freeze drying technology from sp scientific enables the process of developing lyophilisation cycles to be streamlined. Freeze drying process has many advantages and many disadvantages. In pharmaceutical field lyophilization has become important subject to ongoing development and its expansion. Lyophilisation freeze drying is a multistage process with different risks present at each stage. Automatic process development and optimization by the freeze dryer during the first laboratory experiment based on sound scientific principles. In a typical freezedrying cycle, a product is placed in vials and dried on a shelf in a freeze dryer by first lowering the temperature sufficiently to ensure that the product is completely frozen. Lyophilization is common, but cost intensive and hence one of the key objectives during freezedrying process development is to minimize the drying time mainly primary drying time, which is the. Freeze drying is a water removal process typically used to preserve perishable materials, to extend shelf life or make the material more convenient for transport. Feb 12, 2019 process recipes are input into the dryer and the user initiates the freeze drying cycle, from this point the process runs without operator intervention to apply this technology.