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The Powerful, Portable,

Palm-Sized Pharmaceutical
Identification System

Discover the
Raman Advantage
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.
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 Options


PharmaID, 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 direct
sample analysis.

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

Optimized Design, Superior Technology

Patented Free Space Optical Design facilitates the superior 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 Raman 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 sacrifice sample resolution or quality of the photo-response.
The systems resolution of ~8 cm-1 makes PharmaID wellsuited for unknown material identification and pass/fail
discrimination algorithms.
PharmaID has met rigorous standards for stability and robustness through multiple tests, including MilSpec Vibration, 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, audit 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 applications 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 Data

The 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 Unscrambler RX, 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
Unscrambler RX module. Spectral transformation steps

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 1

Figure 2

Interpret and Manage Results Easily

Pass/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 Specifications


Raman Spectrum Range

300 - 2500 cm-1

Spectral Resolution

8 - 10 cm-1 FWHM across range

Laser

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

Collection Optics

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

System Stability

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

Exposure and Sampling Time

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

Battery

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

Power

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

Weight

14 oz (397 g)

Size

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

Operating Temperature

-20 - 40 C

Bar Code Operation

Optional external bar code reader with Bluetooth communications

Sampling Accessories

Vial Holder, Point-and-Shoot, Right Angle

Compliance

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

Protocols/Standards for Compliance

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

Headquarters
SciAps, Inc.
2 Constitution Way
Woburn, MA 01801
339-927-9455
www.sciaps.com
sales@sciaps.com

Engineering and
Manufacturing
SciAps, Inc.
5452 Aerospace Drive
Laramie, WY 82072
03/2013

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