02 September 2010
High Shear wet granulation is a very common process in the pharmaceutical industry. For safety reasons, water will be used in most processes as granulation liquid. However, for a number of reasons, the use of water is not always possible and one has to resort to using organic solvents. One reason, for example, is a problem with the stability of the active ingredient in water. Another reason organic solvents are used is the much shorter drying times compared to water, because of the much lower drying energy requirement.
When using organic solvents for granulation, certain issues arise which need to be addressed:
- explosion risk
- emission of solvent vapors
The Collette™ UltimaPro™ by GEA Pharma Systems nv brings a solution to both issues. This Single Pot Processor combines the process of high shear wet granulation with drying options such as vacuum and microwave drying, thereby combining all operations of the granulation process in one piece of equipment.
The explosion risk when working with a Single Pot Processor can be easily taken away by using an inertization strategy: the air present in the processor vessel is removed and replaced with inert nitrogen, thereby removing one of the three necessary components for creating an explosion. As the machine remains closed during the process, and no air is exchanged with the environment, only a minimal amount of nitrogen is required compared to other commonly used drying processes which require continuous use of nitrogen. Another advantage of using a Single Pot Processor for solvent processes – related to explosion safety – is the fact that drying takes place in a vacuum, and is therefore in an oxygen deprived situation (even without inertization).
The other issue of solvent vapor emission is easily addressed when using a Single Pot Processor. As the system is vacuum-tight, only solvent vapors will be created during the drying process, which will not be mixed with air. This makes it easy to use simple condensation as a means of reducing or eliminating solvent emission at the exhaust of the drying system without any additional investment. The vacuum system of the UltimaPro™ consists of a very efficient combination of condensers (chilled to an appropriate temperature for solvent condensation) and vacuum pumps to ensure both fast and safe drying. This way solvent emission is minimal as is the solvent contaminated waste to be treated (only the condensed solvent).
The UltimaPro™ Single Pot Processor is available for testing in the Process Development Center of GEA Pharma Systems nv in Wommelgem, Belgium. Other typical applications for Single Pot Processing are high containment projects (e.g. for oncology or hormones) and effervescent processes.
More about GEA Pharma Systems
GEA Pharma Systems is dedicated to innovation and thereby providing durable quality through its well-established brands: Aeromatic-Fielder™ and Collette™ - batch and continuous granulation, drying, pelletizing and coating; BuckŪ - contained materials handling; Courtoy™ - tablet compression; and Lyophil™ - pharmaceutical freeze drying.
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Griet Van Vaerenbergh
GEA Pharma Systems nv
Keerbaan 70, B-2160 Wommelgem, Belgium
Tel +32 3 350 12 92 Fax +32 3 353 20 55
E-mail: griet.vanvaerenbergh@geagroup.com
www.gea-ps.com