EMPRESA ESPECIALIZADA EN LA DISTRIBUCIÓN DE EQUIPOS DE INVESTIGACIÓN Y CONTROL DE CALIDAD.

MÁS DE 15 AÑOS DE EXPERIENCIAEN EL MERCADO ESPAÑOL .

CAPACIDAD DE ADAPTACIÓN A LAS NECESIDADES ESPECÍFICAS DE SUS CLIENTES BASADA EN:

•EXPERIENCIA Y ESPECIALIZACIÓN•COMPLETA LÍNEA DE PRODUCTOS•RECURSOS PROPIOS PARA LAS INSTALACIONES•ASISTENCIA TÉCNICA POSTVENTA

CUATRO DIVISIONES:

• CARACTERIZACIÓN DE MATERIALES

• ANÁLISIS DE LABORATORIO

• ESPECTROSCOPÍA

• LÁSER Y OPTOELECTRÓNICA

EQUIPOS PRESENTADOS EN NUESTRO STAND C5

• TRUSCAN

• XPLORA

• BLUEWAVE Y NANOTRAC

• ATLAS Y FRX

Handheld Raman for material verification

Battery powered (>5 hours)

Rugged & Lightweight

21CFR part 11 compliance

Integrated Barcode scanner

Web-based administration

Network Sync to report archives

IQ/OQ documentation

24/7/365 support

barcode scanner

accessories

Raman SpectroscopyElastic Scattering

Wavelength of light is unchanged

Inelastic ScatteringLonger wavelength light

Rayleigh

Raman

Laser

1,000,000

photons

1 photon

TruScan

500 1000 1500 2000 2500 3000

-100

0

100

200

300

400

500

600

-100

100

200

300

400

500

600

700

800

900

0

ephedrine 3 second exposure

acetaminophen 250 ms exposure

Raman shift (∆∆∆∆ cm-1)500 1000 1500 2000 2500 3000500 1000 1500 2000 2500 3000

-100

0

100

200

300

400

500

600

-100

0

100

200

300

400

500

600

-100

100

200

300

400

500

600

700

800

900

0

-100

100

200

300

400

500

600

700

800

900

0

ephedrine 3 second exposure

acetaminophen 250 ms exposure

Raman shift (∆∆∆∆ cm-1)

200

400

600

800

1000

1200

1400

1600

1800

0

500 1000 1500 2000 2500 3000-200

0

200

400

600

800

1000

1200

1400

Raman shift (∆∆∆∆ cm-1)

α-lactose 10 second exposure

D-fructose 10 second exposure

200

400

600

800

1000

1200

1400

1600

1800

0

200

400

600

800

1000

1200

1400

1600

1800

0

500 1000 1500 2000 2500 3000-200

0

200

400

600

800

1000

1200

1400

-200

0

200

400

600

800

1000

1200

1400

Raman shift (∆∆∆∆ cm-1)

α-lactose 10 second exposure

D-fructose 10 second exposure

Diastereomers

500 1000 1500 2000 2500 3000

� ephedrine

� pseudoephedrine

�

NHCH3

CH3

OH

�

NHCH3

OH

CH3

Raman shift (∆ cm-1)

Hydrates

dextrose monohydrate

dextrose, anhydrous

Raman shift (∆ cm-1)

500 1000 1500 2000 2500 3000

FluorescenceLooks like this … the broad background is due to fluorescence. It is an

additional source of noise, and if present, will slow down the data acquisition

(in extreme cases, even prohibiting data acquisition)

Raman shift (∆ cm-1)

cou

nts

500 1000 1500 2000 2500 3000

spectrum of soy proteinexample of extreme fluorescence

spectrum of animal-derived monoglyceridesexample moderate fluorescence,

but suitable for material ID

Fast Adoption in Pharma Industry• Truscan is new standard for raw materials ID

Running the System

Hands-OnTruScan

– Main menu: RUNning a method

• Running exposed materials (getting focus), materials in standard vials, in non-standard glass and plastic containers, materials in bags, tablets and capsules

– Main menu: TEST (system check)

– Main menu: SYNC (send data to archive)

– Main menu: TOOLS (developer/admin only functions)

WebAdmin

– Managing users

– Managing methods

– System settings

– Save/load configuration

– Help (PDF of user manual)

TruScanTM System Logic

NO YES

determine if aspects of

measurement statistically

contradict reference model

Suspect(Raman evidence of

discrepancy)

PASS(no Raman evidence to

believe otherwise)

measurement reference

(library)

TruScanTM System Logic

Analytical Discovery

NO YES

present solution declare no resolution;

present similar library

records

yes no

determine if aspects of

measurement statistically

contradict reference model

Suspect(Raman evidence of

discrepancy)

PASS(no Raman evidence to

believe otherwise)

measurement

{ option, if desired, admin tool}

reference

(library)

Searches all existing methods and Ahura factory library items

for a match. Similar to FirstDefender logic, but

different algorithms.

Regulatory Considerations

• Access controlled by username, password– 3 user levels: user, method developer, administrator– Configurable lock-outs for failed login attempts, inactivity timeouts

• Restricted workflow for routine testing• Electronic records created for each test

– Record of: user, date/time, last login time, method/code, batch/code, note, test spectrum, reference spectrum, goodness-of-fit, pass/fail, system health evaluation, date/time of last full self-test

– Archive formats: configurable as any/all of Ahura serialized binary (ARZ), JPEGformatted report, PDF formatted report, SPC (open binary format), TEXT

• SYNC benefits from TCP/IP fault protection (ensures against packet-loss or corruption during transfer/archive) and transaction verification

• E-records directly delivered to configurable vault destination on SYNC• SYNC delivers all system transaction logs directly to vault• Full system configuration (including library) can be backed-up AND/OR shared

across multiple systems – configure one system appropriately and imprint onto sister systems

Building Methods

Method Building Process

Acquire reference data,

ActivatePopulate Fields, Attachreference spectra, save.

� �

Creating Methods (Chapter 5)Acquire � Activate � Attach

Available Methods

Method creation/editingName to appear on the

handheld, and electronic

records

barcode reference for method

(e.g., RM-ID#)

HTML and/or image files

uploaded to the handheld

(e.g., MSDS, special handling)

enabled/disabled on the

handheld

spectrum management

Installation and Method Validation

Rapid Method ValidationRapid Method Validation

Intent is to create a ‘fake’method that will always fail and trigger discovery analysis.

Since discovery analysis will evaluate all current methods, the selectivity of the methods for the material in question will be challenged.

This result means that the material

passes the method of interest, and fails against all other

methods (selectivity)

Raman vs. FTIR, NIR

IR Absorption versus RamanAbsorption/Reflectance

Raman Scattering

all wavelengths in some wavelengths absorbed/reflected

single wavelength (laser) multiple wavelengths emitted

mid-IR NIR reflectance Raman

Mechanism: absorption by fundamental molecular vibrational modes

Molecular Specificity: high

Signal Strength: strong

Energy: ~ 600-4000 cm-1

Sampling: direct material contact required, glass and water appear opaque; can rarely see through container materials

Hardware: cooled detectors required; probes extremely expensive, and short in length -- portability, ruggedness issues

Mechanism: absorption by harmonics of fundamental vibrational modes of X-H bonds (e.g., N-H, O-H)

Molecular Specificity: low

Signal Strength: weak

Energy: 4000-12,500 cm-1

Sampling: non-contact, but close proximity to material required (<5 mm)

Hardware: longer probes possible (meters); quartz optics; interferometry common; cooled detectors -- portability, ruggedness issues

Mechanism: elastic scattering by fundamental molecular vibrational modes

Molecular Specificity: high

Signal Strength: weak

Energy: 200-3000 cm-1

Sampling: stand-off sampling possible (18-24 mm for FirstDefender; much longer distances possible); confocal aspect enables sampling through containers

Hardware: no moving parts; CCD detection; quartz optics; long probes common (kilometers in some cases)

advantage/disadvantageCompetitive TechnologiesCompetitive Technologies

TruScan VS Benchtop NIR

TruScan

1. Handheld, shock resistant, water and dust proof unit

2. Fast implementation (less than 2 months for up to 100 methods)

3. No need to revalidate methods. Existing methods can be propagated to new units

4. Insensitive to transparent packaging (up to a given thickness)

5. Can verify liquids as well as solids without any specific accessory

Benchtop NIR

1. Laboratory based unit, temperature and dust sensitive

2. Long implementation process (many years for 100 methods)

3. Revalidation necessary if environmental factors change (packaging)

4. Packaging matrix visible on spectra, may or may not be removed

5. Special probe necessary for liquid verification