MVS. Multichannel Verification System

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1 MVS Mutichanne Verification System

2 Increase iquid handing quaity with easy, reiabe performance verification. Are your iquid handers transferring critica voumes accuratey and precisey? Woud you know if they weren t? Automated iquid handers are essentia components in many aboratories. In order to increase the productivity and usefuness of these systems, it is important to understand how voume transfer steps can infuence assay performance, especiay for transfer of critica target voumes. Each critica voume transfer step is directy tied to assay integrity and subsequent interpretation of the experimenta resuts. Without knowing the exact voume transferred at each step of an assay, the concentration of species in soution is unknown, potentiay eading to unreiabe resuts, deays, and cost overruns. Utiization of the Arte MVS for performance verification can prevent probems, boster aboratory productivity, and provide confidence in the integrity of data.

3 The MVS is recognized by many of our customers and is used in their own abs. It is an industry standard, so our customers know they are comparing appes to appes when they see our resuts. The MVS provides us with non-subjective data that buids credibiity with our customers. Director of Appications Robotic Liquid Hander Manufacturer MVS Mutichanne Verification System Takes just minutes. Requires no specia skis. Saves time and abor. Minimizes iquid hander downtime. Advantages of Superior Technoogy Universa Performance verification for any iquid hander, pipettor or dispenser up to 384 channes. Easier than other methods Environmenta contros are not required, as with gravimetry. There is no need to prepare soutions or generate standard curves. Precision and accuracy for each tip In one measurement, dua-dye ratiometric photometry assesses the precision (repeatabiity of voume transfer) and accuracy (coseness of transferred voume to target voume) for each tip simutaneousy at voumes as ow as 10 nl. Standardized resuts MVS measurement resuts are traceabe to the Internationa System of Units (SI) via standards maintained by NIST (US) and NPL (UK). This aows for direct comparison and measurement consistency between operators, methods and iquid handers regardess of make, mode, manufacturer or ocation. Simpe integration On-site vaidation and user training by Arte ensure efficient startup and seamess integration into your process.

4 With the MVS, you can: Measure aqueous as we as non-aqueous voume transfers of user-specific soutions such as dimethy sufoxide (DMSO) Assess step-wise diution accuracy Integrate seamessy with iquid handers for wak-away, in-process QC Faciitate scae-up and method transfer Troubeshoot assays and methods Ensure reproducibiity of repicate pates Monitor a critica target voumes in an assay or process Compare factory to site acceptance testing for new iquid handers Estabish baseine performance of any iquid hander Minimize waste of expensive or rare reagents Deveop, optimize and vaidate iquid hander methods Verify target voumes dispensed into any container incuding tubes, v-bottom or non-opticay cear microtiter pates Monitor the impact of repeated tip usage on iquid hander performance Verify iquid hander performance before and after maintenance Evauate the effect of tip type on iquid hander performance Measure residua voumes remaining in a pate after sampe aspiration Assess performance of other essentia iquid handing equipment such as pate shakers, pate washers and buk dispensers. and much more.

5 We have used severa different methodoogies [to caibrate our iquid handing robots], from gravimetric readings to our own dye system. The Arte MVS has simpified this process and improved the quaity of our resuts. Jay Snabe Genomic Heath Simpe voume verification with automatic reporting. 1. Dispense Soutions. Dispense the Sampe Soution and Diuent into a Verification Pate and mix. 2. Read Pate. Measure the absorbance vaues with the pate reader. 3. Know Performance. Resuts indicate the performance of the iquid hander. Protoco ID, date/time stamp, test criteria Traceabiity stamp, incuding MVS system performance specifications Overa iquid hander performance reative to user-defined toerance imits Accuracy and precision vaues for each tip Voumes reported for every we Resuts outside of the toerance imits are highighted Fu report aso contains ot numbers, materias used, expiration dates, eectronic signatures, comments, etc.

6 Unique MVS components Caibrator Pate The Caibrator Pate is used to correct for day-to-day performance variations in the pate reader. The pate is composed of neutra density gass and five seaed cuvettes containing soutions made with the same dyes used in the Sampe Soutions. Absorbance measurements of the Caibrator Pate are compared to the bar code, which contains the absorbance vaues for each of the cuvettes, as measured in the Arte reference spectrophotometer which is caibrated to standards maintained by NIST (US) and NPL (UK). Verification Pates By measuring the dimensiona quaities and performance characteristics of microtiter pates for each manufactured ot, Arte has minimized the uncertainty associated with the pate used in the voume verification process. The bottom diameter (D) and taper ange of the side wa (θ) are measured by a NIST-traceabe coordinate measuring machine, and ot-specific information is stored on the bar codes. Sampe Soutions MVS Sampe Soutions are manufactured to strict toerances to ensure ot-to-ot consistency. The Sampe Soutions are suppied at different concentrations to enabe voume measurements as ow as 10 nl. θ D The MVS provides accurate measurement performance not avaiabe with other methods such as gravimetry. As the target voume decreases, the appropriate Sampe Soution contains an increased concentration of dye, thereby maintaining the necessary absorbance signa strength to be easiy measured.

7 We seected MVS because it wi aow us to compy with cglp initiatives, due to the NIST-traceabiity and 21 CFR Part 11 software. In addition, we wi be abe to standardize our aboratory sites wordwide by using a singe technoogy to caibrate a of our automated iquid handers. Senior Scientist Mutinationa Biopharmaceutica Company and dua-dye ratiometric photometry provide confidence and contro. MVS uses unique components and dua-dye ratiometric photometry to measure the voume transfer performance of iquid handers. The iquid hander being tested dispenses Sampe Soution containing both red and bue dyes into the dimensionay-characterized Verification Pate. The wes are fied to a working voume by adding a non-quantitative amount of Diuent, which contains bue dye at the same concentration as the bue dye in the Sampe Soution. The Beer-Lambert Law reates the measured absorbance (A) of a soution at a given waveength (λ) to the moar absorptivity (ε) of the soution at waveength λ, the concentration (C) of dye in the soution, and the pathength of ight () through the soution: A λ = ε λ C. The concentration and the moar absorptivity are combined into a new term caed the absorbance per pathength (a λ ), which is embedded in each soution bar code, and is defined by the equation: a λ = ε λ C. Independent determination of sampe voume for each we proceeds via three cacuations: 1. The bue dye, with absorbance per unit pathength (a b ) at 730 nm, is used to cacuate the pathength: = A 730 /a b 2. Based on this pathength, MVS cacuates tota we iquid voume (V T ) using the pate dimensions θ and D contained on the pate bar code. 3. Using the ratiometric equation, the voume of Sampe Soution (V S ) is cacuated from this tota voume, the known absorbances per pathength (a r and a b ), and the measured absorbances from the pate reader (A 520 and A 730 ): This resut is independent of the amount of Diuent added. Dua-dye ratiometric photometry ight source fiters 520 nm 730 nm V S (sampe voume) (pathength) V T (tota voume) Sampe Soution is dispensed into each we (eft). Diuent is dispensed into each we (center) and the pate is mixed. Absorbance measurements for each dye are coected (right) and the sampe voume is cacuated as described above. A 520 A 730 detector

8 Arte is the wordwide eader in iquid handing quaity assurance. Since 1982, Arte systems have been proven in daiy use in thousands of pharmaceutica, cinica, forensic, pubic heath, government, academic, and environmenta aboratories. These eading aboratories depend on Arte technoogy to meet their objectives for quaity, productivity, and reguatory compiance. ISO Certified QMS MVS PATENTS The MVS and its components are covered by patents: US 6,741,365; US 7,187,455; US 7,791,716; US 7,998,747; US 8,003,405; US 7,061,608; EP ; DE ; JP ; JP ; and other US and Foreign Patents Pending. Trust Your Resuts 25 Bradey Drive, Westbrook, Maine to-free: te: fax: emai: info@arte-usa.com 19A5593G

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