Malvern launches mobile on-line particle size analyzer for pharmaceutical industry

New York, NY(April 26-28) At Interphex 2005, Malvern Instruments will display its established Insitec T on-line particle size analyzer and will introduce a new pharmaceutical industry-specific version of its innovative Insitec Voyager system. The Insitec Voyager is a mobile, on-line particle size analyzer that can be attached to fixed sampling ports at a variety of points in a production line. It can also be used to sample from different production lines within the same manufacturing plant. Insitec Voyager for the pharmaceutical industry is based on the standard Insitec Voyager platform, but will offer a fully validatable, pharmaceutical industry compliant package.

Mobile, modular and cleanable, the Insitec Pharma Voyager features a touchscreen monitor for clean and easy operation. It meets current GAMP requirements, with a simple to clean cell and flowpath, and the system features triclamping and 316 stainless steel parts for easy cleaning. Its software enables full compliance with the FDA’s 21 CFR Part 11 requirements.

The Insitec Voyager is the first ever standard mobile unit for real-time on-line particle sizing. It can be used on-line and at-line. The system is ideal for pharmaceutical sites where there are many manufacturing lines requiring optimization, or for first-time buyers who would like to evaluate the use of on-line particle sizing for the application.

Insitec Voyager systems use the same proven technology and rugged platform that is the foundation for all Malvern’s Insitec range of on-line particle sizers. The Voyager unit houses all the instrumentation and software needed for on-line particle size analysis and can be moved easily around a plant. Voyager is suitable for use even in highly regulated environments.

On-line particle sizing facilitates real-time optimization of process parameters and configurations. Being a laser diffraction-based system, Malvern Insitec offers benefits in that the technique requires no calibration nor does it need the long data acquisition intervals that can mask true process behaviour.

With laser diffraction techniques, laser light is scattered by particles in the sample and the angular intensity is measured by a series of photodetectors. Smaller particles scatter light at greater angles than larger ones and the resulting diffraction pattern is used to measure particle size. By applying the rigorous Mie light scattering theory to the data, the complete particle size distribution can be ascertained.

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