1. Handheld Raman Spectrometer
NanoRam
Handheld Raman Spectrometer
Joe Colamarino

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

3. NanoRam What is Raman Spectroscopy? Vibrational spectroscopy
785 nm excitation wavelength
Complies with USP<1120> and ESP Ch guidelines for Raman spectroscopy
Accepted cGMP testing method

4. NanoRam Raman Technology
Optimal excitation wavelength of 785nm to reduce fluorescence
Complies with USP<1120> and EP Ch guidelines for Raman spectroscopy
Accepted cGMP analytical testing method to replace wet chemistry: ICH Q2 R1 |

5. 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

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

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

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

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

10. 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

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

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

13. NanoRam Regulation Compliance
Supports CFR21 Part 11 Electronic Records and Signature Protocols
Supports CFR21 Part Performance Standards for Light Emitting Products 
Complies with USP<1120> and ESP Ch guidelines for Raman spectroscopy
ASTM 1840 Raman Shift Standards for spectrometer calibration

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

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

16. 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

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

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

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

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

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

22. Thank you for your attention

23. Advantages of Raman Spectroscopy

24. Broad Class of Containers

25. BWT Proprietary 58