Handheld Raman Spectrometer NanoRam Handheld Raman Spectrometer Joe Colamarino

NanoRam Raman based technology Handheld size for portability and versatility Chemical ID

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

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

NanoRam Applications Incoming raw materials Powders, liquids, gels, solids, inside or outside of containers Final packaging and non-destructive QC inspection

NanoRam Raw Material ID Average less than 1 minute per sample Multiple samples per drum Complete QC process in minutes

NanoRam Ease of Use No lab required From truck to production in minutes No specialized training required for use

NanoRam Instrument Operation Accessories Multiple front end adapters for sampling integrity Adapters for bottles, bags, tablets and more Safety adapter for laser activity

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

NanoRam Instrument Menu Operation (cont.) Managerial level access to set parameters of operations

NanoRam Quality Control Fully compliant to all regulations Personalized and flexible reporting functions PDF format for report security

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

NanoRam Reporting Flexibility Direct connection to a computer for downloading data Individualized report format capabilities High storage capacity for preferred download scheduling

NanoRam Service and Support Calibration and calibration verification DQ/IQ/OQ/PQ Extended warranty programs On-site technical support

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

NanoRam Warranty Programs One year factory warranty Extended warranty programs of 2 or 3 years total Can be combined with calibration services for discounts

NanoRam Technical Support Pre-loaded libraries On-site method development, training and other support services available Factory technical support available

NanoRam Technical Support (cont.) IQ/OQ documentation available IQ/OQ execution by factory personnel available Complete validation support, in-house or on-site

NanoRam Savings Instrument capital costs Processing raw materials No delays in pass/fail reporting

NanoRam NanoRam QC Process Control Raman Technology Library Handheld Ease of Use Speed of Analysis Library QC Process Control

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Advantages of Raman Spectroscopy www.bwtek.com

Broad Class of Containers

BWT Proprietary 58