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Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.

Mar 31, 2015

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Darian Sawin
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Page 1: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.
Page 2: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.
Page 3: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.
Page 4: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.
Page 5: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.
Page 6: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.
Page 7: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.

Validation in a box

Generic procedure for all makes of equipment

Contains all software, materials and consumables required for self-validation or for your service provider

Traceability of all materials

Range of kits available for HPLC and GC

Calibrated v:tools

Training

Page 8: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.

Developed by NLG Analytical Ltd

Based upon years of validation experience

Allow companies to control their own equipment qualification process

Increase compliance - reduce costs

Straightforward use

Complete hplc test takes about four hours

Page 9: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.
Page 10: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.
Page 11: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.

For complete ease of use, all traceability information is provided with v:kits

This provides an auditor with instant access to all trace information they might require, without needing to go to external sources

Page 12: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.

v:kit has been designed to achieve two key benefits :

1. to reduce your cost of compliance

at the same time as

2. increasing your degree of compliance

Page 13: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.

the future of laboratory testingThe ability to self-validate with reduced costs, reduced risk,

and high integrity is the way forward for organisationsof all sizes - from labs with a single piece of testing equipment,

to multi-site, multi-nationals

Page 14: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.
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Designed to integrate with the materials and protocols used within v:kits, v:tools are supplied with traceable calibration certificates and a re-calibration service is offered for all v:tools to ensure that you maintain your regulatory compliance.

Keep your v:tools validated - return to NLG Analytical Ltd for re-calibration. For more information call: +44(0)1625 574 633 or Email: [email protected]

Page 44: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.

VKIT - LFMThe v:kit digital flowmeter is designed specifically for HPLC applications is supplied with a certificatetraceable to NAMAS (the UK equivalent to NIST)

SpecificationsMeasuring Range: 0.05-25ml/min Resolution 1µl/min Calibration Calibrated at 1.0ml/min

with NAMAS traceable calibration certificate

Display 4-digit LCD displayAccuracy +/-1% of readingReproducibility +/-0.5%Power Supply 9V

Part Number3pin UK 240v V:KIT-LFM-UK2pin Europe 220v V:KIT-LFM-EU2pin USA 120v V:KIT-LFM-US

Page 45: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.

VKIT - GFMThe v:kit Digital Gas Flowmeter is ideal for use in gas chromatography applications and canbe used for any gas used in gc, eg Hydrogen, Helium, Air, Nitrogen and even mixtures such as Argon/Methane

SpecificationsMeasurement Range 0.1-1000ml/minMeasurement Principal Volumetric flow

measurementsAccuracy +/- 3% of readingTraceability Supplied with

certificate traceable to NIST

Part Number V:KIT-GFM

Page 46: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.

VKIT - TPA multi-purpose meter, the v: kit Digital Temperature Probe can be used for accurate and traceable temperature readings for HPLC and GC temperature controlled zones

SpecificationsMeasurement Range -50°C-1300°CResolution 0.1°CAccuracy ±0·3% of reading

@ -50°C ~ 200°C±0·4% of reading @ 200°C ~ 1000°C

Thermocouple Type KCalibration Supplied with certificate traceable to NAMAS/UKASPower Supply 9V Part Number V:KIT-VTP

Page 47: Validation in a box Generic procedure for all makes of equipment Contains all software, materials and consumables required for self-validation.

VKIT - SPTake the strain out of delivering detector accuracy and linearity solutions by using the v: kit Syringe Pump

It also allows easier flushing of detector cells, permitting quicker detector OQ. Dispense volume is tracked and displayed continuously.   When the preset volume has been dispensed, the pump shuts-off automatically

SpecificationsDelivery volume up to 50mlDelivery speed variable, 0.01l /min

–50ml /min

Power Supply 110V-240V withexternal adaptor

Accuracy + / - 0.1 mm or +/- 1% of total distance

Display 2 line LCD 20 characters per line

Drive Motor Pulse free DC motor with variable speed setting

Part Number V:KIT-SYP`

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El software está diseñado para windows 95, 98, 2000, NT y XP y se adquiere inicialmente con 2 licencias. Proporciona automáticamente los informes normalizados incluyendo datos de desviación, incertidumbre, trazabilidad y criterios de pasa/fallo.Para posteriores validaciones se adquieren los repuestos que incluyen los patrones con su correspondiente certificado.

ANÁLISIS VÍNICOS S.L. C/ Los Pastores, 38. 13700 Tomelloso – Ciudad Real. España. E-Mail: [email protected] HOME: www.analisisvinicos.com