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Schreiner
rochling

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  2. Solving Pharma Dosing Challenges Through Smart Automation

Solving Pharma Dosing Challenges Through Smart Automation

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By admin on Wed, 04/11/2012 - 08:37

Peptides play a critical role in the modern physicians toolkit. But peptides and related substances present unique manufacturing challenges. Small quantities of expensive materials are typically handmeasured product is moved from a singlesource container to a fixed targetweight batch in a timeconsuming and errorprone method that often results in costly overfills. Is there a better waymanually, sale weights ranging from 1 mg to several100 mg often require 2 to 3 minutes per fill to achieve a withintolerance fill. Substances such as peptides and proteins require multistep synthesis, making them quite expensive&mdashand not the kind of thing any processor or distributor relishes giving away for free. Overfilling to ensure minimum standards are met can reduce already thin profit margins. But magnify the giveaway concern repeat the operation 30, 100 or 1,000 times in one batch. Manual dosing becomes a fulfillment quagmire&mdashtiring for operators, costly for companies. Automated cost savingsone swiss biochemical company faced the unenviable logistical challenge of supplying a catalog of more than 4,400 chemicals on a timely basis to pharmaceutical industry buyers. After evaluating how much money they were losing to overfills, and to meet increased demand for their products, the company began seeking ways to enhance productivity. Mettler toledo determined quantos with an autosampler offered an ideal solution to this manufacturer&rsquos bottling challenge. The quantos doses 30 target vessels of differing target weights without operator interaction, taking 30to60 seconds per vessel&mdashfour times faster than a manual fill. Autogenerated labels simplified filled vial tracking. And, specialized vialfitting adapters reduce electrostatic effects, which can be a concern with automated solutions. The company&rsquos productivity increased more than fourfold in just ten months. Overfilling has also been reduced from 9 to just 2, contributing to significant monetary gains. Added benefits of exact fillsautomated exactness is critical over and underfills risk unintended side effects, and underfills particularly run afoul of strict biochemical regulation. Eu regulation 76211ewg alone states that "the actual mass of the contents of a flask can vary to maximum 9 compared to the written label." when considering these production pressures, the cost of implementing an automated system to enhance dosing precision pales in comparison to the potential costs of not doing so&mdashparticularly when handling small amounts of expensive and potentially volatile materials in the highly competitive&mdashand highly regulated&mdashpharmaceutical arena. For more specifics on mettler toledo solutions for automated dispensing of weights between 1mg and 250mg to improve productivity and reduce costs, visit www.mt.comquantos case study in cost savingsinstalling two combination quantosautosampler machines to relieve pressure on manual filling at one manufacturer resulted in the following savings  annual consumable costs 2.530,00 &euro net investment costs 49.000,00 &euro total annual gross savings 62.968,85 &euro fiveyear savings will equal 252.494,26 the automated system paid for itself in less than 10 months. Dosing examplethe table below shows a summary of dosing data from multiple replicates of four typical peptides at varying targetdose amounts substance target dose mgmean actual dose mgno. Of replicatesaccuracy rsd mean dosagetime s bocglnalaargamc 5 5.19 30 3.83 2.66 47sucalaalaalapna 1000 1005.09 31 0.51 0.28 228hdpheproarg 25 25.39 75 1.58 1.04 23hippurylhisleuoh 250 251.78 73 0.71 0.55 68 3075 samples of each peptide were dosed on the quantos qb5 system in a single batch. The mean dosing time for target amounts between 1 250mg was 48 seconds. Accuracy of dosing is typically less than 2. Mettlertoledo aglaboratory divisionim langacherch8606 greifensee, switzerlandsubject to technical changes.© mettlertoledo ag 1109printed in switzerlandquantos marketing switzerland

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