PharmaLIBS™ 250 by PHARMA LASER - Eisai Machinery U.S.A. Inc.

EIS (Eisai Inspection System)

FOR RAPID, RELIABLE TESTING OF SOLID AND ORAL DOSAGE

The PharmaLIBS™ 250 is an innovative, patented, laser-based analytical instrument designed for rapid, reliable pharmaceutical materials analysis and process monitoring. The PharmaLIBS™ 250 can be used throughout the pre-formulation and formulation process.

Analyses up to twenty-six(26) tablets per acquisition, takes few seconds to a minute per tablet, many applications such as:

Blend and tablet uniformity
Coating thickness uniformity
Coating content uniformity
API and excipient tablet distribution
Dosage and excipient concentration qualification

LASER-INDUCED BREAKDOWN SPECTROSCOPY

The physical process of LIBS begins with focusing a high-energy laser pulse on a sample of interest. The laser-matter reaction generates a plasma which contains chemical characteristic light. The light is then analyzed for quantitative and qualitative results.

PharmaLIBS™ 250

PharmaLIBS™ 250 is a fully integrated and automated analytical instrument based on LIBS technology. The PharmaLIBS™ 250 was designed to meet pharmaceutical requirements. Results are displayed within second in its user friendly interface. All results are saved and follow 21 CFR Part 11 regulations.


PHARMALIBS™ SOFTWARE The software supports fully automated data acquisition and results processing with graphical and tabular output data that can be exported to Microsoft Excel or text formats. Graphic data can be exported to BMP, WMF, and JPG formats. Fully 21 CFR Part 11 Compliant Software	3D MAPPING LIBS has shown to be an effective tool to rapidly probe the surface and the core of the tablet for various compounds and determine their distributions throughout the sample. The lack of uniformity in distribution can be clearly demonstrated in the surface plots obtained from a single tablet, both means of surface distribution and coating uniformity also can be plotted for single tables.

COATING THICKNESS MEASUREMENT Evaluating the properties of pharmaceutical coatings such as intra-tablet and inter-tablet thickness and uniformity is important for demonstrating adequate process controls and for ensuring the optimal performance of the final product.	EASY AND LOW COST OPERATION Requires no consumables or harzardous materials for operation and is plug and play with minimal installation required. Sample preparation is also not required. No calibration needed before analysis.