New Tool For Characterizing Foreign Particulate Matter In Foreign ...

Tag : Synthetic Fibres

Malvern Instruments has added a new capability to its award-winningMorphologi G3 automated particle characterization system, enablingthe fully automated detection, enumeration and size classificationof foreign particulate matter (FPM) collected on a filter. In thepharmaceutical industry this is especially important in controllingparticulate contamination of materials for injection or inhalation.Analysis of FPM on filters has traditionally been the preserve ofmanual light microscopy. Now, the Morphologi G3 brings fullyautomated image analysis to accelerate characterization and removeany operator subjectivity.
FPM in pharmaceutical preparations derive typically from the activeor excipient material, or from the administration device itself,from abrasion and shearing during activation. Glass, transparentsynthetic fibres, stainless steel, rubber, aluminium, and plasticparticles are just some of the materials that may be involved. USP788 specifies acceptable levels of FPM in injectable drugs; FDAguidance provides regulatory recommendations for foreign particletesting in metered dose inhalers, dry powder inhalers, and nasalsprays and solutions; and testing for FPM in orally inhaled andnasal drug products is also discussed by the InternationalPharmaceutical Aerosol Consortium on Regulation and Science.
As well as generating fast, reproducible results, Morphologi G3provides large amounts of information about each individualparticle, allowing detailed investigation, troubleshooting, andprocess and quality control. Several different sample carriers areavailable for mounting prepared filters of different sizes on tothe Morphologi G3. These allow two filters to be presented andanalyzed successively with no manual intervention. Essential forautomated analysis is their ability to hold the filter paperstretched flat.
The FPM application is fully controlled via the system softwarethrough the Standard Operating Procedures (SOPs). Full automationof the Morphologi G3 using SOPs eliminates any user bias inherentin manual microscopy methods. SOPs also allow straightforwardmethod development and easy electronic transfer. FPM are measured,down to 2 µm in size, in a short time, and are automaticallyclassified into specified size brackets.
Automatic calibration, conformance to 21CFR part 11 requirementsand the availability of full IQ/OQ documentation ensure that theMorphologi G3 is accurate and repeatable and all data is secure andvalidated. www.malvern.com/LabEng/products/morphologi/contamination_monitoring.htm
About Malvern Instruments
Malvern Instruments provides a range of complementary materialscharacterization tools that deliver inter-related measurementsreflecting the complexities of particulates and disperse systems,nanomaterials and macromolecules. Analytical instruments fromMalvern are used in the characterization of a wide variety ofmaterials, from industrial bulk powders to the latest nanomaterialsand delicate macromolecules. A broad portfolio of innovativetechnologies is combined with intelligent, user-friendly software.These systems deliver industrially relevant data enabling ourcustomers to make the connection between micro (such as particlesize) and macro (bulk) material properties (rheology) and chemicalcomposition (chemical imaging).
Particle size distribution, particle shape information, zetapotential, molecular weight, chemical composition, and bulkmaterials properties can all be determined with instruments fromthe Malvern range. The company's laboratory, at-line, on-line andin-line solutions are proven in sectors as diverse as cementproduction and pharmaceutical drug discovery.
Headquartered in Malvern, UK, Malvern Instruments has subsidiaryorganizations in all major European markets, North America, China,Korea and Japan, a joint venture in India, a global distributornetwork and applications laboratories around the world. www.malvern.com .
SOURCE: Malvern Instruments