7 January 2009: Malvern, UK: New pilot-scale research in the Pharmacy Department of the National University of Singapore is demonstrating the value of the Insitec in-line particle size analyzer from Malvern Instruments, for monitoring and control of spray drying processes. Process Analytical Technology (PAT) options, such as the Insitec, are used increasingly in the pharmaceutical manufacturing industry at the pilot plant stage to enable Quality by Design. Here the analyzer was installed to monitor the performance of a spray drier producing oil-loaded microspheres in the size range 10 - 35 microns.
Spray-drying is a technique that is commonly used by the industry to modify product properties. The particle size of the resulting material is typically a key performance variable, routinely measured by off-line analysis. The microspheres produced by Professor Heng's research group, in this study, were oily, and prone to agglomeration, making measurement challenging.
Using the Insitec laser diffraction in-line continuous analyzer, the complete product stream was measured, optimizing the statistical relevance of the data. Produced in real time, the measurement data provided insight into the process dynamics allowing, for example, start-up time to be accurately determined, so that no in-specification material was wasted. The research team found the technique hugely preferable to light microscopy, which although useful for off-line measurement, is tedious and time-consuming, and ill-suited to the process environment.
Insitec technology can be used at-, in- or on-line to measure both wet and dry systems containing particles in the size range 0.1 to 1000 microns. At- and on-line analyses both provide the opportunity for sample treatment, prior to measurement, which can be especially valuable for the accurate characterization of materials that are prone to agglomeration. Data acquisition rates are as high as four complete measurements per second, so the analyzer can monitor even the most rapidly changing processes. The real-time measurements produced are ideal for monitoring, and for the automated control, of a wide range of processes.
To view the full research paper visit www.malvern.com/common/downloads/campaign/MRK1110-01.pdf
About Malvern Instruments
Malvern Instruments provides a range of complementary materials characterization tools that deliver inter-related measurements reflecting the complexities of particulates and disperse systems, nanomaterials and macromolecules. Analytical instruments from Malvern are used in the characterization of a wide variety of materials, from industrial bulk powders to the latest nanomaterials and delicate macromolecules. A broad portfolio of innovative technologies is combined with intelligent, user-friendly software. These systems deliver industrially relevant data enabling our customers to make the connection between micro (such as particle size) and macro (bulk) material properties (rheology) and chemical composition (chemical imaging).
Particle size distribution, particle shape information, zeta potential, molecular weight, chemical composition, and bulk materials properties can all be determined with instruments from the Malvern range. The company's laboratory, at-line, on-line and in-line solutions are proven in sectors as diverse as cement production and pharmaceutical drug discovery.
Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, China, Korea and Japan, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com
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