Particle Size Analyzer suits pharmaceutical applications.
Press Release Summary:
On-line Insitec Pharma Voyager combines laser diffraction-based Insitec X dry powder analyzer, measurement electronics, cabling, and pneumatics in mobile system with HMI. Available in inline or by-pass configurations, system meets GAMP requirements with triclamping and 316 SS parts. Software enables full compliance with FDA's 21 CFR Part 11 requirements. System requires no calibration or lengthy data acquisition intervals that can mask true process behavior.
Original Press Release:
Mobile On-Line Particle Size Analyzer for Pharmaceuticals
Malvern's new pharmaceutical industry-specific version of the company's innovative Insitec Voyager system is now available worldwide. The Insitec Pharma Voyager is a mobile, on-line particle size analyzer that is based on the standard Voyager platform, but offers a fully validatable, pharmaceutical industry compliant package.
The Pharma Voyager combines the Insitec X dry powder analyzer (an intrinsically safe in-process particle size analyzer designed for real-time measurement of dry powders and for hazardous area applications), and all necessary measurement electronics, cabling and pneumatics in a compact mobile system with a human machine interface (HMI). Pharma Voyager is ideal for pilot plant operation or process analytical technology (PAT) research where mobility, cleanability, and ease of operation are essential. The Voyager can be easily moved to production at any point.
Operation of the Pharma Voyager is straightforward. The Insitec X optical head is removed from the cart and installed directly to the process line. There are two standard configurations; inline or by-pass. The inline design is a flange placed directly in the process stream with all material passing through the analyzer. The by-pass configuration consists of an eductor system used for high concentration applications or to aid dispersion.
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.
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. www.malvern.co.uk
About Malvern Instruments
Malvern Instruments is a leading supplier of analytical solutions for particle characterization and rheological applications. Advanced technologies are combined with robust mechanical designs and comprehensive software to provide systems that measure material characterization data (size distribution, particle shape, zeta potential, molecular weight) and bulk material properties. On-line, at-line and off-line solutions are provided to meet QA/QC, control and development applications across a diverse range of industries. An extensive support service facilitates the optimal design and exploitation of any given system.
USA contact:
Marisa Fraser, Malvern Instruments Inc
10 Southville Road
Southborough, MA 01772, USA
Tel: +1 508 480 0200
Fax: +1 508 460 9692
marisa.fraser@malvernusa.com
Please send sales enquiries to:
Alison Vines, Malvern Instruments Ltd
Enigma Business Park, Grovewood Road
Malvern, Worcestershire UK
WR14 1XZ
Tel: +44 (0) 1684 892456
Fax: +44 (0) 1684 892789
salesinfo@malvern.co.uk
