Spotlight Cooling & Freezing Technologies New Integrated Equipment for Bulk Production of Freeze-Dried APIs
The Telstar Group has developed an integrated automatic system for the bulk production of freeze-dried APIs under isolated conditions. Through this technology, developed for use in the USA by one of the major global pharmaceutical companies, Telstar is now able to implement solutions that combine in-house freeze-drying and containment technologies with those of automatic handling of trays of product. The system features automatic dispensing of the liquid product, the subsequent unloading of the solid form and automatic transfer to a storage hopper. Telstar is also developing solutions for the downstream processing following freeze-drying and product unloading, wherein the dry product is dosed into aluminium canisters, with all operations being performed under aseptic conditions inside isolators. For the bulk production of freeze-dried APIs, Telstar has developed a complete freeze-drying system with automatic handling of product trays under aseptic conditions, integrated into a containment isolator. Specifically designed for the freeze-drying of materials such as polypeptides, the handling of which can involve a exposure risk for operators, the system incorporates a containment isolator between the product and the operator which allows a level of operator exposure of less than 1µg/m3 to be achieved and maintained throughout the course of an eight-hour shift. The isolator's main chamber, of vertical laminar flow, contains the mechanisms that automatically feed and extract the product trays from the freeze-dryer chamber. The system features two independent TSCs (Tray Storage Carts); one connected to each side of the main chamber of the isolator, where the product trays are stored once the freeze-dried product has been unloaded. Following the freeze-drying process, the dry product is removed from
the trays using a vacuum system, which transports it to a cyclone where it is separated from the airstream and collected in a hopper, to be transported to the next step in the production process. In the second phase of the project, Telstar will incorporate into this piece of equipment the sterile downstream process of transferring the solid, freeze-dried product to process stations where it is dosed it into aluminium canisters; all under aseptic conditions within isolators.
Circle no. 101 Mass Production of Packaging for Freeze-Dried Drugs
Schott announced at the Pharma Symposium in Mainz, Germany, that it has started mass production of its TopLyo™ pharmaceutical packaging for lyophilised (freeze-dried) drugs at its Muellheim, Germany, facility. The TopLyo solution features a special geometry and an ultrathin hydrophobic coating that is so smooth and homogeneous that freeze dried drugs cannot adhere to the inside walls of the container. As a result, the so-called lyophilisation cake shows a better appearance and enables less disruption of dry material, as well as reduced breakage during the lyophilisation process. Initial capacity of the plant is six million packaging units a year. The Schott TopLyo™ containers currently come in two sizes, 2 and 10ml. “We are also planning a 6 ml container shortly,“ said Dr Claudia Dietrich, Product Manager Vials Coating at Schott forma vitrum. The coating is applied by the proprietary Schott PICVD technology - Plasma Impulse Chemical Vapor Deposition, in a validated and constantly inspected process. The entire layer is only 40 nanometers thick and therefore has no effect on the dimensions of the pharmaceutical container. It is stable to pharmaceutical processes such as washing, sterilisation and depyrogenization (heat treatment of 300°C).
In the pharmaceutical area, lyophilisation is used to extend the shelf life of highly sensitive ingredients, such as proteins, that are produced biotechnologically. “This is an important development for the future. After all, biomolecules are already being used today in over 50% of all product developments in pharmaceutical therapy,” explained Dr Dietrich. The advantage of freeze-drying is its ability to preserve products for a longer period of time, keeping their effectiveness stable and better protecting the highly effective and sensitive ingredients. Such preparations are used, for example, in oncology. The TopLyo vials have been designed with a special geometry to maximise strength and minimise breakage, and also to improve heat transfer during the lyophilisation process.
Circle no. 102 ADVERTORIAL New for 2010…
Celebrating 45 years in the industry
We can now offer a bespoke range of cabinets for you to choose the size, volume, layout, specification and material finish.
Circle no. 103
Cooled Incubators Series 2
The LMS Cooled Incubator is a reliable and accurate temperature controlled cabinet (-10°C to +50°C ) which has proved its worth over many years in laboratories both in the UK and overseas.
The design of the purpose built incubator facilitates the addition of optional extras to provide greater flexibility for individual use, making it suitable for a wide range of applications including:
• The study of growth patterns of plants and insects
• B.O.D.Tests
• Seed germination & vernalisation
in cooled incubation Specialist
With a reputation you can trust -10˚C to +50˚C
LMS Limited, The Modern Forge Riverhead, Sevenoaks, Kent TN13 2EL
Tel: 01732 451 866 • Fax: 01732 450 127 email:
sales@lms.ltd.uk •
www.lms.ltd.uk
Circle no. 104
• Tissue culture • Enzyme testing • Serum studies • Immunology • Fruit fly culture • Sample storage • Product shelf life tests
Circle no. 105
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