Handheld Raman Analyzer RaPort

Pharmacy

Enhanced Spectrometry – globally acknowledged developer of Raman and luminescent solutions

Established in 2009

Specialists with 20 years of Raman and luminescent technologies experience

Worldwide distribution network

EnSpectr products have passed CE-certification

21 CFR 11 software requirements compatibility

GMP EU compatibility

IQ/ OQ/ PQ documentation

Method: Raman spectroscopy

Raman spectroscopy

Allows to get individual inherent spectral “fingerprint” of the substance It is one of the most accurate methods at the moment as each ”fingerprint“ is unique

Advantages of the method: Quick measurements through transparent and semi-transparent package Analysis of liquids, powders, tablets, gels Portability Full-range in-field use No sample preparation required No expensive operation supplies

Task: Meeting important quality standards

GMP EU Since it is necessary to use “effective monitoring and control systems for process performance and product quality” and insure that “medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life” which means:

High-accuracy results through package No sample preparation or direct contact Measurement time – 3 s.

Solution: Handheld

Raman analyzer RaPort

Check the quality of new deliveries Confirm the quality of stated substances Perform control check of the components before mixing them with new deliveries

21 CFR 11

De facto is the standard for a number of pharmaceutical organizations all over the world. Among others states the transparency of data transmission and storage, as well as contains professional database operation guidelines.

RaPort for incoming materials analysis: perform the check instantly at the warehouse

Attachments

Best price!

Measurement time 3 seconds

Measurement type Identification, match search, quantitative analysis of mixtures

Accessories Attachments for bottles, plastic packages (indirect operation) and direct measurements of samples

Raman databases and libraries

Specialized reference databases can be enlarged or created by user

Data transmission and storage

Wireless transmission to a tablet /smartphone/ PC

Connection Bluetooth (built-in) and Wi-Fi (via tablet)

Data format Set by user (.txt, .csv, .spc etc)

Program software EnSpectr Pro Software for Windows / Android OS

Battery 8 hours of continuous operation. Changeable unit.

Weight 2 kg

Meeting CFR 21 requirements with EnSpectr

Section 11.10 (e) – For electronic records, this section requires the use of computers-generated, time-stamped audit-trails to track changes.

The software keeps track of all changes that affect saved spectra-data. Any action in the software that modifies the original data is logged. The log of such changes is individually maintained for each Spectra and is referred to as History in the software.

Section 11.3 (b) (4) – This section mandates that the system be controlled by users responsible overall for contents of electronic records required to track.

The software provides an elaborate system of maintaining secure user accounts. Assign unique user names and passwords to all the users who will be using the software. Each account can also be configured to provide read or modify access to other users’ data. Events generated in the audit trail (above) are logged with the user name.

Instant non-invasive analysis through glass ampoules and semi transparent plastic blisters

* Sample spectra obtained while equipping infield laboratories of Russian Federal Service on Surveillance in Healthcare and Social Development

Real-time quantitative analysis of ampoules contents The only handheld Raman spectrometer that can measure water which enables : Quantitative analysis of active substance even in minimal concentrations due to comparison of the substance and water lines

* Sample spectra obtained while equipping infield laboratories of Russian Federal Service on Surveillance in Healthcare and Social Development

Substance identification through semi-transparent plastic package

* Sample spectra obtained while equipping infield laboratories of Russian Federal Service on Surveillance in Healthcare and Social Development

Tablets identification

Mixture recognition: EnSpectr professional software enables qualitative analysis of multi-compound mixtures and solutions

Excellent choice worldwide!

The only Raman-luminescent spectrometer on the market

21 CFR 11 and GMP EU compatibility

3 s per measurement

(while traditional approaches require up to a week)

Quantitative analysis of active substances

in concentrations down to 1%

6 hours of autonomous operation

All data in your smartphone on Windows / Android OS

RaPort: features and benefits

* The opportunity of luminescence analysis contributes to EnSpectr unique technology of counterfeit protection using Spectral markers

MixSplitter: qualitative and quantitative analysis of heterogeneous

powders (Results of chromatomass analysis instantly in-field!)

MixSplitter analyses each grain of the mixture which improves the limit of detection of residual contaminant (detects pieces of 10 µm size) and ensures more accurate identification of components concentration – down to 0.1 %

MixSplitter: automatically scans and identifies

mixed substances’ compounds

Camera image of heterogeneous powder. Made with RamMics microscope.

The result of the scanning presents the number and characteristics of mixture compounds and their percentage ratio Number of mixed compounds is unlimited.

Detection Limit:

0,5% within 20 minutes

0,1 % within 100 minutes

Error depending on impurity concentration:

For 0.5% impurity: - 20% for 100 min

For two-compound

mixture 1:1

- 7% for 20 min

- 3% for 100 min

Unique technology for product marking to ensure quality control and prevent counterfeit Raman-luminescent markers are detected through package

Alcohol

Marker

Sample spectra of diesel gas oil with different marker concentrations. The software identifies concentrations automatically.

Advantages of EnSpectr spectral markers technology

Fast and accurate identification of marker concentrations (the extent of original product ‘s dilution)

The newest and unique patented Raman-luminescent technology cuts off counterfeit

Marker measurement through package

Since the product is measured (not the package) it is possible to additionally control the product chemical composition using the instrument for marker analysis

Low marker concentration down to 0.1 ppm doesn’t affect the quality or properties of main substance

Optional information coding using a combination of markers

Optional use of certified food supplements as markers

Enhanced Spectrometry, Inc. 2033 Gateway Place, #500 San Jose, CA 95128, USA

www.enspectr.org info@enspectr.org