New Tool For Characterizing Foreign Particulate Matter In Foreign Particulate Matter

Malvern Instruments has added a new capability to its award-winning Morphologi G3 automated particle characterization system, enabling the fully automated detection, enumeration and size classification of foreign particulate matter (FPM) collected on a filter. In the pharmaceutical industry this is especially important in controlling particulate contamination of materials for injection or inhalation. Analysis of FPM on filters has traditionally been the preserve of manual light microscopy. Now, the Morphologi G3 brings fully automated image analysis to accelerate characterization and remove any operator subjectivity.

FPM in pharmaceutical preparations derive typically from the active or excipient material, or from the administration device itself, from abrasion and shearing during activation. Glass, transparent synthetic fibres, stainless steel, rubber, aluminium, and plastic particles are just some of the materials that may be involved. USP 788 specifies acceptable levels of FPM in injectable drugs; FDA guidance provides regulatory recommendations for foreign particle testing in metered dose inhalers, dry powder inhalers, and nasal sprays and solutions; and testing for FPM in orally inhaled and nasal drug products is also discussed by the International Pharmaceutical Aerosol Consortium on Regulation and Science.

As well as generating fast, reproducible results, Morphologi G3 provides large amounts of information about each individual particle, allowing detailed investigation, troubleshooting, and process and quality control. Several different sample carriers are available for mounting prepared filters of different sizes on to the Morphologi G3. These allow two filters to be presented and analyzed successively with no manual intervention. Essential for automated analysis is their ability to hold the filter paper stretched flat.

The FPM application is fully controlled via the system software through the Standard Operating Procedures (SOPs). Full automation of the Morphologi G3 using SOPs eliminates any user bias inherent in manual microscopy methods. SOPs also allow straightforward method development and easy electronic transfer. FPM are measured, down to 2 µm in size, in a short time, and are automatically classified into specified size brackets.

Automatic calibration, conformance to 21CFR part 11 requirements and the availability of full IQ/OQ documentation ensure that the Morphologi G3 is accurate and repeatable and all data is secure and validated. www.malvern.com/LabEng/products/morphologi/contamination_monitoring.htm

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.

SOURCE: Malvern Instruments