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

Transcription

1 EMPRESA ESPECIALIZADA EN LA DISTRIBUCIÓN DE EQUIPOS DE INVESTIGACIÓN Y CONTROL DE CALIDAD. MÁS DE 15 AÑOS DE EXPERIENCIA EN 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

2 CUATRO DIVISIONES: CARACTERIZACIÓN DE MATERIALES ANÁLISIS DE LABORATORIO ESPECTROSCOPÍA LÁSER Y OPTOELECTRÓNICA

3 EQUIPOS PRESENTADOS EN NUESTRO STAND C5 TRUSCAN XPLORA BLUEWAVE Y NANOTRAC ATLAS Y FRX

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5 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

6 barcode scanner accessories

7 Raman Spectroscopy Elastic Scattering Wavelength of light is unchanged Rayleigh 1,000,000 photons Laser Raman 1 photon Inelastic Scattering Longer wavelength light

8 ephedrine 3 second exposure TruScan α-lactose 10 second exposure acetaminophen 250 ms exposure D-fructose 10 second exposure Raman shift ( cm -1 ) Raman shift ( cm -1 )

9 Diastereomers OH ❶ pseudoephedrine ❶ CH 3 NH CH 3 OH ❷ ephedrine ❷ CH 3 NH CH Raman shift ( cm -1 )

10 Hydrates dextrose monohydrate dextrose, anhydrous Raman shift ( cm -1 )

11 Fluorescence Looks 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) counts spectrum of animal-derived monoglycerides example moderate fluorescence, but suitable for material ID spectrum of soy protein example of extreme fluorescence Raman shift ( cm -1 )

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

13 Running the System

14 TruScan Hands-On Main menu: RUNning a method Running exposed materials (getting focus), materials in standardvials, 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)

15 TruScan TM System Logic measurement determine if aspects of measurement statistically contradict reference model reference (library) NO PASS (no Raman evidence to believe otherwise) YES Suspect (Raman evidence of discrepancy)

16 TruScan TM System Logic measurement reference (library) determine if aspects of measurement statistically contradict reference model NO PASS (no Raman evidence to believe otherwise) YES Suspect (Raman evidence of discrepancy) { option, if desired, admin tool} Searches all existing methods and Ahura factory library items for a match. Similar to FirstDefender logic, but different algorithms. yes present solution Analytical Discovery no declare no resolution; present similar library records

17 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), JPEG formatted 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

18 Building Methods

19 Method Building Process ❶ ❷ Acquire reference data, Activate Populate Fields, Attach reference spectra, save.

20 Creating Methods (Chapter 5) Acquire Activate Attach

21 Available Methods

22 Method creation/editing Name 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

23 Installation and Method Validation

24 Rapid 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.

25 This result means that the material passes the method of interest, and fails against all other methods (selectivity)

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27 Raman vs. FTIR, NIR

28 IR Absorption versus Raman Absorption/Reflectance all wavelengths in some wavelengths absorbed/reflected Raman Scattering single wavelength (laser) multiple wavelengths emitted

29 Competitive Technologies advantage/disadvantage mid-ir NIR reflectance Raman Mechanism: absorption by fundamental molecular vibrational modes Mechanism: absorption by harmonics of fundamental vibrational modes of X-H bonds(e.g., N-H, O-H) Mechanism: elastic scattering by fundamental molecular vibrational modes Molecular Specificity: high Signal Strength: strong Molecular Specificity: low Signal Strength: weak Molecular Specificity: high Signal Strength: weak Energy: ~ cm -1 Sampling: direct material contact required, glass and water appear opaque; can rarely see through container materials Energy: ,500 cm -1 Sampling: non-contact, but close proximity to material required (<5 mm) Energy: cm -1 Sampling: stand-off sampling possible (18-24 mm for FirstDefender; much longer distances possible); confocal aspect enables sampling through containers Hardware: cooled detectors required; probes extremely expensive, and short in length -- portability, ruggedness issues Hardware: longer probes possible (meters); quartz optics; interferometry common; cooled detectors --portability, ruggedness issues Hardware: no moving parts; CCD detection; quartz optics; long probes common (kilometers in some cases)

30 TruScan VS Benchtop NIR TruScan Benchtop NIR 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 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