Inclusion of lyophiliser with auto loading/ unloading and orabs is an instance of Sakar Healthcare’s progress and its efforts to ensure quality on every front
Lyophilisation also known as freeze drying, lyophilisation or cryodesiccation is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport. Lyophilisation should be used when the product meets one or more of the following criteria: unstable; heat liable; minimum particulates required; accurate dosing needed; quick; complete rehydration needed; high value.
It uses a commonly known 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 vapour without passing through a liquid phase. The process consists of three separate, unique, and interdependent processes.
Adoption of automated loading and unloading systems, clean-in-place systems, and controlling and monitoring systems in freeze drying systems in order to minimise manual errors, improve processing time, and reduce operating costs are expected to promote greater uptake of technologically advanced freeze drying systems in the global healthcare industry.
In recent years, the freeze drying equipment accounted for the largest share of the global freeze drying market; whereas, freeze drying accessories accounted for the remaining share of this market. As in last year, Asia-pacific region accounted for the largest share of the global freeze drying market, followed by North America and Europe. Furthermore, in the forthcoming years, developing regions such as Asia-Pacific (China and India) and Latin America (Brazil, Mexico, Argentina) are expected to provide strong revenue growth opportunities for the market players. Economic developments, rising shift of pharmaceutical and biotech industries from developed countries to Asia-Pacific and Latin American regions, growing investments of foreign freeze drying market players in these regions, and increasing private investments and venture funding to support new biopharma product developments in these regions are the key factors driving the growth of the freeze drying market in developing regions.
New product launches and partnerships, agreements, and collaborations are the key strategies adopted by leading market players in the past three years to ensure their growth in the market.
Principle: The main principle involved in freeze drying is a phenomenon called sublimation, where water passes directly from solid state (ice) to the vapour state without passing through the liquid state. Sublimation of water can take place at pressures and temperature below triple point. The material to be dried is first frozen and then subjected under a high vacuum to heat so that frozen liquid sublimes leaving only solid dried components of the original liquid. The concentration gradient of water vapour between the drying front and condenser is the driving force for removal of water during lyophilisation.
Equipment: There are mainly three types of freeze-dryers: the manifold freeze-dryer, the rotary freeze-dryer and the tray style freeze-dryer. Two basic parts are common to all types of freeze-dryers: a vacuum pump to reduce the ambient gas pressure in a vessel containing the substance to be dried and a condenser to remove the moisture by condensation on a surface cooled. The manifold, rotary and tray type freeze-dryers differ in the principle implied by which the dried substance is interfaced with a condenser. In manifold freeze-dryers a short usually circular tube is used to connect multiple containers with the dried product to a condenser. The rotary and tray freeze-dryers have a single large reservoir for the dried substance.
Rotary freeze-dryers are usually used for drying pellets, cubes and other pourable substances. The rotary dryers have a cylindrical reservoir that is rotated during drying to achieve a more uniform drying throughout the substance. Tray style freeze-dryers usually have rectangular reservoir with shelves on which products, such as pharma solutions and tissue extracts, can be placed in trays, vials and other containers.
Manifold freeze-dryers are usually used in a laboratory setting when drying liquid substances in small containers and when the product will be used in a short period of time. A manifold dryer will dry the product to less than five per cent moisture content. Without heat, only primary drying (removal of the unbound water) can be achieved. A heater must be added for secondary drying, which will remove the bound water and will produce lower moisture content.
Tray style freeze-dryers are typically larger than the manifold dryers and are more sophisticated. Tray style freeze-dryers are used to dry a variety of materials. A tray freeze-dryer is used to produce the driest product for long-term storage. A tray freeze-dryer allows the product to be frozen in place and performs both primary (unbound water removal) and secondary (bound water removal) freeze-drying, thus producing the driest possible end-product. Tray freeze-dryers can dry products in bulk or in vials or other containers. When drying in vials, the freeze-dryer is supplied with a stoppering mechanism that allows a stopper to be pressed into place, sealing the vial before it is exposed to the atmosphere. This is used for long-term storage, such as vaccines.
Improved freeze drying techniques are being developed to extend the range of products that can be freeze dried, to improve the quality of the product, and to produce the product faster with less labour.
Excipients in lyophilised formulation
The design of a lyophilised formulation is dependent on the requirements of the active pharmaceutical ingredient (API) and intended route of administration. A formulation may consist of one or more excipients that perform one or more functions. Excipients may be characterised as buffers and pH adjusters, bulking agents, stabilisers and tonicity modifiers.
Importance in pharma industry
This technique is extensively being used in pharma industry in order to increase shelf life of products like vaccines and other injectables. Removal of water from the material and sealing in a vial, the final product can be stored and transported easily and finally reconstituted to its original form for injection.
Sakar Healthcare has opted for this value added process of lyophilsation to cater as per industry needs. The lyophiliser with auto loading / unloading and orabs would ensure benefits to esteemed clienteles both – domestic and international. Sakar Healthcare is ready to manufacture and market brands with enhanced stability and shelf life – with ease in handling and transportation. With transition to Sakar Healthcare, value added lyophiliser and increased marketing presence across the globe, the organisation is rightly placed at a platform to venture into developed markets with relevant approvals.