NanoRam
Handheld Raman Spectrometer
Joe Colamarino
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NanoRam
 Raman based
technology
 Handheld size for
portability and
versatility
 Chemical ID
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NanoRam
What is Raman Spectroscopy?
 Vibrational spectroscopy
 785 nm excitation
wavelength
 Complies with
USP<1120> and ESP
Ch.2.2.48 guidelines for
Raman spectroscopy
 Accepted cGMP testing
method
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NanoRam
Raman Technology
 Optimal excitation
wavelength of 785nm to
reduce fluorescence
 Complies with USP<1120>
and EP Ch.2.2.48 guidelines
for Raman spectroscopy
 Accepted cGMP analytical
testing method to replace
wet chemistry: ICH Q2 R1
www.bwtek.com | www.nanoram.com
NanoRam
Innovations
 State of the art laser and
cooled sensor technology
increases sensitivity
 Open software design for
third party software
applications
 Transfer libraries from
instrument to instrument
easily
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NanoRam
Applications
 Incoming raw materials
 Powders, liquids, gels,
solids, inside or outside
of containers
 Final packaging and
non-destructive QC
inspection
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NanoRam
Raw Material ID
 Average less than 1
minute per sample
 Multiple samples per
drum
 Complete QC process in
minutes
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NanoRam
Ease of Use
 No lab required
 From truck to production
in minutes
 No specialized training
required for use
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NanoRam
Instrument Operation
Accessories
 Multiple front end adapters for sampling
integrity
 Adapters for bottles, bags, tablets and
more
 Safety adapter for laser activity
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NanoRam
Instrument Menu Operation
 Touch screen with on-screen keyboard
 Lightweight at 2.2 lbs. and able to be used
with either hand
 Easy to read screen for quick menu usage
 Managerial access levels allow for secure
areas of the software
 Users are designated with passwords
 Traceability of all activity with the instrument
and the users
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NanoRam
Instrument Menu Operation (cont.)
 Managerial level
access to set
parameters of
operations
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NanoRam
Quality Control
 Fully compliant to all
regulations
 Personalized and
flexible reporting
functions
 PDF format for report
security
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NanoRam
Regulation Compliance

Supports CFR21 Part 11 Electronic Records and Signature Protocols

Supports CFR21 Part 1040.10 Performance Standards for Light Emitting
Products

Complies with USP<1120> and ESP Ch.2.2.48 guidelines for Raman
spectroscopy

ASTM 1840 Raman Shift Standards for spectrometer calibration
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NanoRam
Reporting Flexibility
 Direct connection to a
computer for
downloading data
 Individualized report
format capabilities
 High storage capacity
for preferred download
scheduling
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NanoRam
Service and Support
 Calibration and
calibration verification
 DQ/IQ/OQ/PQ
 Extended warranty
programs
 On-site technical
support
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NanoRam
Instrument Calibration
 Factory calibration
recommended twice per
year
 Calibration verification
using polystyrene takes
less than one minute
 Cal verification can be
done per batch, per day,
or another parameter
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NanoRam
Warranty Programs
 One year factory
warranty
 Extended warranty
programs of 2 or 3 years
total
 Can be combined with
calibration services for
discounts
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NanoRam
Technical Support
 Pre-loaded libraries
 On-site method
development, training
and other support
services available
 Factory technical
support available
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NanoRam
Technical Support (cont.)
 IQ/OQ documentation
available
 IQ/OQ execution by
factory personnel
available
 Complete validation
support, in-house or onsite
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NanoRam
Savings
 Instrument capital costs
 Processing raw
materials
 No delays in pass/fail
reporting
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NanoRam
NanoRam
QC
Process
Control
Raman
Technology
Library
Speed of
Analysis
Handheld
Ease of
Use
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Thank you for your attention
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Advantages of Raman Spectroscopy
www.bwtek.com
Broad Class of Containers
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BWT Proprietary
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