Ordering information Reference Description Auto-Validation Software 890-0050 Auto-Validation software – One license needed per computer (can be used for all LaChrom Elite instruments attached to one PC) Accessories 4.02011.0001 Teflon tube 0.25 mm ID x 10 m Recommended accessories 609-1118 Stop watch DELTA E200 620-4703 Thermometer QTemp 500 620-4705 Temperature sensor ALS300 (two units are needed) Consumables 1.19161.0001 Set 7: Precision (OQ) 60 mg/l methyl paraben in methanol 1.19162.0001 Set 8: Linearity (OQ) Dilution series of methyl paraben in methanol (concentrations: 1.5 ; 7.5 ; 15 ; 75 ; 150 mg/l) 1.19163.0001 Caffeine solution A for gradient test (OQ) 20 mg/l caffeine in water 1.19164.0001 Caffeine solution B for gradient test (OQ) 20 mg/l caffeine in methanol 1.15333.1000 Water, Lichrosolv 1.06007.1000 Methanol, Lichrosolv 1.50164.0001 LiChroCART 125-4 HPLC Cartridge Autovalidation – A new tool to qualify your Hitachi LaChrom Elite ® HPLC. Austria VWR International GmbH Graumanngasse 7 A - 1150 Wien Tel: +43 1 97 002-0 Fax: +43 1 97 002 600 E-mail: [email protected] Belgium VWR International bvba Haasrode Researchpark Zone 3 Geldenaaksebaan 464 B - 3001 Leuven Tel: +32 16 385011 Fax: +32 16 385385 E-mail: [email protected] Denmark VWR International ApS Roskildevej 16 DK - 2620 Albertslund Tel: +45 43 86 87 88 Fax: +45 43 86 87 90 E-mail: [email protected] Finland VWR International Oy Pihatörmä 1 C 1 FI - 02240 Espoo Tel: +358 9 804551 Fax: +358 9 80455200 E-mail: [email protected] France VWR International S.A.S. Le Périgares – Bâtiment B 201, rue Carnot F-94126 Fontenay-sous-Bois cedex Tel: 0 825 02 30 30 (0,15 € TTC/min) Fax: 0 825 02 30 35 (0,15 € TTC/min) E-mail: [email protected] Germany VWR International GmbH Hilpertstrasse 20a D - 64295 Darmstadt Tel: +49 6151 3972 500 Fax: +49 6151 3972 441 E-mail: [email protected] Ireland VWR International Ltd Rath Business Park Ashbourne Co. 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Apartado 48 E-08100 Mollet del Vallés - Barcelona Tel: +34 902 19 56 44 Fax: +34 902 19 59 39 E-mail: [email protected] Sweden VWR International AB Fagerstagatan 18a SE - 163 94 Stockholm Tel: +46 8 621 34 00 Fax: +46 8 621 34 66 E-mail: [email protected] Switzerland VWR International AG Lerzenstraße 16/18 CH-8953 Dietikon Tel.+41 44 745 13 13 Gratisfax: 0800 825 429 E-mail: [email protected] The Netherlands VWR International B.V. Postbus 8198 NL - 1005 AD Amsterdam Tel: +31 (0)20 – 4808 400 Fax: +31 (0)20 – 4808 480 E-mail: [email protected] UK VWR International Ltd Customer Service Centre Hunter Boulevard - Magna Park Leicestershire - LE17 4XN Tel: 0800 223344 Fax: +44 1455 558586 E-mail: [email protected] Your European Distribution Partner LaChrom ® , LaChrom Elite ® and ChromSword ® are registered trademarks of VWR International, EZChrom Elite™ is a registered trademark of Scientific Software Inc. The Auto-validation software ● Performs the instrument OQ and produces data which com- plies with the electronic records and electronic signature rule (21 CFR Part 11). ● Keeps all the qualifications performed on an instrument (history). ● Follows all hardware manufacturers standard operating procedures (SOP’s) ● Runs as automatic as possible, freeing the technician and analyst from time-consuming manual procedures. ● Enables system testing as well as single parameters. ● Is fully integrated into the EZChrom Elite platform How often should the instrument OQ be performed? The frequency of OQ depends on the use of the LaChrom Elite instrument, but also on the specified acceptance criteria. The use of the instrument is highly depended on how often analysis are performed (continuous operation?) and how frequently aggressive solvents and samples are analysed. The default acceptance criteria is given by the instrument SOP’s. This will be entered as default values as soon as you start a qualification run. What tests will be performed? The instrument OQ typically comprises the following test items: Pump Tests ● Flow rate Accuracy ● Flow rate Precision ● Gradient Accuracy ● Gradient Ripple Autosampler Tests ● Injection Amount Repeatability ● Carry Over ● Injection Amount Linearity Oven Tests ● Temperature Accuracy ● Temperature Stability Detector Tests ● Lamp Energy ● Wavelength Accuracy ● Auto Zero Function ● Baseline Noise/Drift ● Absorbance Linearity What can EZChrom Elite do for you? ● Performs and documents automatic operational qualification ● Provides qualification data that complies with FDA’s 21 CFR Part 11 ● Increase the productivity by performing a step-by-step qualification with a minimum interaction by the analyst ● Keeps the qualification data online as long as needed to master the next inspection. ZPROVWRI2003EN A new tool to qualify your Hitachi LaChrom Elite ® HPLC Auto-Validation as ms em 07/2005 Autovalidation.qxd 11/07/05 17:09 Page 1