The Powerful, Portable,

Palm-Sized Pharmaceutical
Identification System

Discover 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
O
ptical
design
combined
with proprietary FSX
provides a high performance system thattechnology vers highly accurate and reproducible
deli
results.

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

Flexible Sampling Options

PharmaID, one of the worlds smallest Raman
spectrometers, is ergonomically designed for singledhanded 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 wellsuited 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, 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 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 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.
are predetermined, powerful regression classification
is provided, and different plots are offered on the same
screen for easier data interpretation of the final model

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
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

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.

Figure 2

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

For more information:

www.sciaps.com
sales@sciaps.com

03/2013