The Powerful, Portable, Palm-Sized Pharmaceutical Identification System

PharmaID integrates the technologies and tools necessary for pharmaceutical manufacturing and quality control. Pass/fail methods are designed and managed with intuitive graphical method development software. Methods are transferrable between systems and can be implemented to verify the identification of excipients and Active Pharmaceutical Ingredients (APIs) in receiving areas, at-line, and offsite locations. PharmaID allows pharmaceutical manufacturers to meet regulatory demands, improve product quality through increased testing, reduce identification time and the costly laboratory analysis associated with classical wet chemical methods, identify counterfeit pharmaceuticals, and ensure a fast and ongoing return on investment.

Flexible Sampling OptionsPharmaID, one of the world’s 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 direct sample analysis.

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 Optical design combined with proprietary FSX technology provides a high performance system that delivers highly accurate and reproducible results.

Discover the Raman Advantage

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 pass/fail analysis•Graphics, plots, data importation, auditing, and user controls

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 pass/fail analysis•Graphics, plots, data importation, auditing, and user controls

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.

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

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

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 steps

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. PharmaID’s small size does not sac-rifice sample resolution or quality of the photo-response. The system’s 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.

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.

UserAdministration

Rights

METHODInstrumentOperationalParameters

Algorithms &Tolerances forMaterial ID and

Pass/Fail

Auditingand

Reporting

SCORES

HeadquartersSciAps, Inc.2 Constitution WayWoburn, MA 01801339-927-9455www.sciaps.comsales@sciaps.com

Figure 1

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 (Figure 2), identification, or interpreted metrics for the model matching to the unknown samples.

PharmaID System SpecificationsRaman Spectrum Range

Spectral Resolution

Laser

Collection Optics

System Stability

Exposure and Sampling Time

Battery

Power

Weight

Size

Operating Temperature

Bar Code Operation

Sampling Accessories

Compliance

Protocols/Standards for Compliance

300 - 2500 cm-1

8 - 10 cm-1 FWHM across range

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

Free Space Design, circulized and collimated output beam, 0.7 mm diameter

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

Auto exposure, Manual option, Normal total sampling time is less than 20s

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

100-240 V AC, 50-60 Hz, AC to DC wall adapter or USB connecor to charge PC, optional car adapter

14 oz (397 g)

6”H x 3”W x 1.75”D (15.24 cm x 7.62 cm x 4.44 cm)

-20° - 40° C

Optional external bar code reader with Bluetooth communications

Vial Holder, Point-and-Shoot, Right Angle

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

NIST and ASTM traceable polystyrene, IQ/OQ/PQ procedures and documentation available

03/2013

are 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.

Figure 2

Engineering and ManufacturingSciAps, Inc.5452 Aerospace DriveLaramie, WY 82072