LANCIR II Dedicated NIR Analyzer for Real-time Pharmaceutical Blending Measurements 0 pages

LANCIR II Dedicated NIR Analyzer for
Real-time Pharmaceutical Blending
Measurements
CHICAGO, Illinois -- March 9, 2009 – At Pittcon® 2009, Bruker introduces the all-new
LANCIR II, the next generation on-line Pharmaceutical Process Analytical Technology
(PAT) Analyzer for pharmaceutical characterization and control. The new LANCIR II is a
self-contained, battery operated Near-infrared spectrometer that is dedicated for on-line blend
uniformity monitoring.
Near-infrared spectroscopy has proven to be a rapid, cost-effective, convenient, and nondestructive
routine analysis technique, that is recommended by the Food and Drug
Administration’s Process Analytical Technology (PAT) initiative. Bruker’s new LANCIR II
provides real-time analysis on blending of powders for tablet production to ensure uniform
consistency of active and excipients within a batch. In addition, the system can monitor
components such as moisture to warn when these components are trending outside acceptable
range. Thus making it possible to validate every batch to determine Parametric Release.
The new LANCIR is based on diode array near infrared spectroscopy, and can be mounted
directly onto pilot and production scale blending equipments. It provides high sensitivity, with
detection limits of >1% of pharmaceutical ingredients, including actives and excipients such
as Magnesium Stearate. The system is protected against dust and water (NEMA4 IP65),
allowing decontamination with water or recommended solvents. Bruker offers comprehensive
validation solutions, including IQ/OQ/PQ documentation and the protocols for USP 1119
compliance.
Bruker Optics is the global market leader for implementing PAT solutions to the
Pharmaceutical Industry. The PAT solutions based on NIR, FTIR, Raman and TD-NMR
have been successfully installed in the areas of API production, incoming material control,
blending, drying, granulation, compression & final product assay.