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1 NanoRam Handheld Raman Spectrometer Joe Colamarino.

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Presentation on theme: "1 NanoRam Handheld Raman Spectrometer Joe Colamarino."— Presentation transcript:

1 1 NanoRam Handheld Raman Spectrometer Joe Colamarino

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

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

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

5 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 6 NanoRam Applications  Incoming raw materials  Powders, liquids, gels, solids, inside or outside of containers  Final packaging and non-destructive QC inspection

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

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

9 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 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 11 NanoRam Instrument Menu Operation (cont.)  Managerial level access to set parameters of operations

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

13 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 and ESP Ch guidelines for Raman spectroscopy  ASTM 1840 Raman Shift Standards for spectrometer calibration

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

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

16 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 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 18 NanoRam Technical Support  Pre-loaded libraries  On-site method development, training and other support services available  Factory technical support available

19 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 20 NanoRam Savings  Instrument capital costs  Processing raw materials  No delays in pass/fail reporting

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

22 Thank you for your attention 22

23 Advantages of Raman Spectroscopy

24 Broad Class of Containers 24

25 58 BWT Proprietary

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