The Powerful, Portable,Palm-Sized PharmaceuticalIdentification System

ptical design combined with proprietary FSX technology vers highly accurate and reproducible results.ols ity ed re. e nd ng ws ory ed ory ds, ndDiscover the Raman Advantage with

PharmaID is a powerful, portable system that enables 100% material verification for pharmaceutical manufacturers. It is the ideal solution for the analysis of solutions, gels, powders and a wide range of solid materials. Patented Raman Free Space Oprovides a high performance system that deli

KEY FEATURES Reliable results in seconds 21 CFR Part 11 compliant Palm-sized, one-handed use Rapid return on investment Analysis through containers and packaging Easy and powerful method management with pass/fail analysis Outstanding graphics, plots, data importation,auditing, and user controls

PharmaID integrates the technologies and to necessary for pharmaceutical manufacturing and qual control. Pass/fail methods are designed and manag with intuitive graphical method development softwa Methods are transferrable between systems and can b implemented to verify the identification of excipients a Active Pharmaceutical Ingredients (APIs) in receivi areas, at-line, and offsite locations. PharmaID allo pharmaceutical manufacturers to meet regulat demands, improve product quality through increas testing, reduce identification time and the costly laborat analysis associated with classical wet chemical metho identify counterfeit pharmaceuticals, and ensure a fast a ongoing return on investment.

Flexible Sampling OptionsPharmaID, one of the worlds smallest Raman spectrometers, is ergonomically designed for singled-handed operation. All operational buttons can be contacted with the hand holding the system, leaving the other hand free for sample handling. Disposable sampling tips are available for liquid and powder analysis in 4-12 mm glass vials. Point-and-shoot and right angle sampling tips are available for analyzing liquids directly in their receiving containers, powders in plastic bags, or di- rect sample analysis.Optimized Design, Superior Technology Patented Free Space Optical Design facilitates the supe- rior collection of the Raman scattering signal for maximum signal-to-noise detection. The PharmaID system features FSX technology, creating a stabilized system that delivers outstanding performance. FSX technology offers a single mode 785 nm laser (120 mW) which is TE stabilized and optically controlled with variable bragg grating (VBG) technology. This design optimizes the collection of Ra- man scattered light from the sample, minimizing the laser power required to reduce the risk of photo-bleaching or burning the sample. PharmaIDs small size does not sac- rifice sample resolution or quality of the photo-response. The systems resolution of ~8 cm-1 makes PharmaID well- suited for unknown material identification and pass/fail discrimination algorithms.

PharmaID has met rigorous standards for stability and ro- bustness through multiple tests, including MilSpec Vibra- tion, Drop and Dunk, and NEMA 4 and IP67 classification.

Simple, Powerful Method Management Pharmaceutical manufacturers require material testing equipment that is easy to implement, and offers auditing and reporting procedures that fulfill compliance requirements.

The PharmaID method is central to the operation of the system and incorporates all user rights privileges, au- dit trails and reporting functions, instrument parameters, identification and pass/fail algorithms for materials that require testing. A method is selected for each material tested and is typically named from the material of interest.

NuSpec open architecture software comes standard with PharmaID and offers intuitive method development and management. The elements of a method are managed and interpreted on large displays with standard keyboard/ mouse functions that provide simple to read graphical features. Standard Windows features allow multiple ap- plications to be opened, managed and imported to LIMS systems. Methods that are imported into PharmaID can be selected from a drop down menu or from an external bar code reader.

Get Faster, Deeper Insights from DataThe PharmaID system includes CAMOs Unscrambler RX module to implement pass/fail methods based on multivariate analysis used by researchers, engineers and scientists worldwide.

SCORES

User Administration Rights

Instrument Operational Parameters

METHOD

Algorithms & Tolerances for Material ID and Pass/Fail

Auditing and Reporting

PharmaID is tethered to NuSpec software on a PC and the parameters for the methods are synchronized to the device in a few seconds.

SciAps has tailored the UnscramblerRX, providing a version that facilitates easy data importing options with intuitive workflows, outstanding graphics, plots and interactive visualization tools. Data is collected on PharmaID either in NuSpec or directly from PharmaID and exported into the UnscramblerRX module. Spectral transformation stepsare predetermined, powerful regression classification is provided, and different plots are offered on the same screen for easier data interpretation of the final model results. Interactive data visualization tools are offered for each plot and graph for zooming, rotate and drill down to individual data points. Models that are transported into SciAps methods can be implemented into the software and the firmware of PharmaID for real time pass/fail analysis.

Interpret and Manage Results EasilyPass/fail and library match results are displayed on the PharmaID screen (Figure 1). Or, results can be displayed in NuSpec software as simple pass/fail pop-ups (Figure2), identification, or interpreted metrics for the modelmatching to the unknown samples.

Figure 1

Figure 2

PharmaID System Specifications

Raman Spectrum Range300 - 2500 cm-1

Spectral Resolution8 - 10 cm-1 FWHM across range

Laser785 nm, 120mW, < 100 MHz nm line width, VBG Single Mode Stability < 0.05 cm-1

Collection OpticsFree Space Design, circulized and collimated output beam, 0.7 mm diameter

System StabilityFrequency stability < 0.07 cm-1 and error < 0.6%. Intensity stability < 1% on 1000 scans of toluene.

Exposure and Sampling TimeAuto exposure, Manual option, Normal total sampling time is less than 20s

BatteryRechargeable Li battery, 4 hours operation, recharge 2 hours after full discharge

Power100-240 V AC, 50-60 Hz, AC to DC wall adapter or USB connecor to charge PC, optional car adapter

Weight14 oz (397 g)

Size6H x 3W x 1.75D (15.24 cm x 7.62 cm x 4.44 cm)

Operating Temperature-20 - 40 C

Bar Code OperationOptional external bar code reader with Bluetooth communications

Sampling AccessoriesVial Holder, Point-and-Shoot, Right Angle

ComplianceFDA 1040, 21 CFR part 11, CE certification, MilSpec 810 G Vibration, Drop, Immersion, NEMA4, IP67

Protocols/Standards for ComplianceNIST and ASTM traceable polystyrene, IQ/OQ/PQ procedures and documentation available

For more information: www.sciaps.com sales@sciaps.com

03/2013