Nano Ram Handheld Raman Spectrometer Joe Colamarino 1

Nano. Ram Handheld Raman Spectrometer Joe Colamarino 1

Nano. Raman based technology Handheld size for portability and versatility Chemical ID 2

Nano. Ram 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 c. GMP testing method 3

Nano. Raman Technology Optimal excitation wavelength of 785 nm to reduce fluorescence Complies with USP<1120> and EP Ch. 2. 2. 48 guidelines for Raman spectroscopy Accepted c. GMP analytical testing method to replace wet chemistry: ICH Q 2 R 1 www. bwtek. com | www. nanoram. com

Nano. Ram 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 5

Nano. Ram Applications Incoming raw materials Powders, liquids, gels, solids, inside or outside of containers Final packaging and non -destructive QC inspection 6

Nano. Ram Raw Material ID Average less than 1 minute per sample Multiple samples per drum Complete QC process in minutes 7

Nano. Ram Ease of Use No lab required From truck to production in minutes No specialized training required for use 8

Nano. Ram Instrument Operation Accessories Multiple front end adapters for sampling integrity Adapters for bottles, bags, tablets and more Safety adapter for laser activity 9

Nano. Ram 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 10

Nano. Ram Instrument Menu Operation (cont. ) Managerial level access to set parameters of operations 11

Nano. Ram Quality Control Fully compliant to all regulations Personalized and flexible reporting functions PDF format for report security 12

Nano. Ram Regulation Compliance Supports CFR 21 Part 11 Electronic Records and Signature Protocols Supports CFR 21 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 13

Nano. Ram Reporting Flexibility Direct connection to a computer for downloading data Individualized report format capabilities High storage capacity for preferred download scheduling 14

Nano. Ram Service and Support Calibration and calibration verification DQ/IQ/OQ/PQ Extended warranty programs On-site technical support 15

Nano. Ram 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 16

Nano. Ram Warranty Programs One year factory warranty Extended warranty programs of 2 or 3 years total Can be combined with calibration services for discounts 17

Nano. Ram Technical Support Pre-loaded libraries On-site method development, training and other support services available Factory technical support available 18

Nano. Ram Technical Support (cont. ) IQ/OQ documentation available IQ/OQ execution by factory personnel available Complete validation support, in-house or onsite 19

Nano. Ram Savings Instrument capital costs Processing raw materials No delays in pass/fail reporting 20

Nano. Ram QC Process Control Nano. Raman Technology Library Speed of Analysis Handheld Ease of Use 21

Thank you for your attention 22

Advantages of Raman Spectroscopy www. bwtek. com

Broad Class of Containers 24

BWT Proprietary 58