Laboratory Products 37 Autoclave Controller Software Meeting FDA 21 CFR Part 11 Guidelines Introduced
Astell Scientific is pleased to announce the launch of a new software option that enables its full range of autoclaves to meet FDA 21 CFR Part 11 electronic signature regulations.
The software is targeted towards customers operating in the pharmaceutical and medical manufacturing industries, but can bring benefits to a much wider range of applications should traceability be of key importance when specifying a steriliser.
The basic requirement of the Electronic Records; Electronic Signature final rule (21 CFR 11) legislation is to ensure that any computerised system used for regulatory purposes produces electronic records that have integrity and reliability, and that electronic signatures are trustworthy and equivalent to handwritten signatures executed on paper records. Astell’s latest software combined with its advanced touchscreen controller positions the company as one of few autoclave manufacturers able to provide a solution that complies with FDA 21 CFR Part 11.
Available across both circular and square section sterilisers, the specially developed 21 CFR 11 controller software captures any change made to a cycle, option, or device parameter, which will require an electronic signature authorisation. All device changes and signatures will be electronically logged and can be recalled to provide a clear picture of user input for any given point in time. All audit trails are saved in a file format that cannot be altered in any way.
Astell spokesperson Dave Thomas commented: “The introduction of FDA compliant autoclave software offers our customers the transparency and record management required by tightly regulated industries. It’s another good reason to choose Astell Scientific, and demonstrates why we remain the leaders in sterilisation.”
For more information on Astell’s FDA 21 CFR Part 11 software option, its applications or capabilities please visit
www.astell.com/21cfr11.
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Next Generation ONH Analysers
Eltra presents the latest generation of ONH analysers for the determination of oxygen, nitrogen and hydrogen in inorganic materials with a fresh new design and advanced features.
Highest precision with even better reproducibility of the measurement results combined with a considerably reduced consumption of carrier gas are the main features of the ELEMENTRAC®
New System Provides Accurate and Safe Bottle-top Dispensing of Many Common Laboratory Liquids
Gilson, an industry leader in liquid handling, purification, and extraction systems, have introduced DISPENSMAN™, a bottle-top dispenser for convenient, safe, and precise delivery of common laboratory solutions and solvents. DISPENSMAN continues the innovation of Gilson’s liquid handling line, which also includes PIPETMAN® continuously adjustable-volume pipette.
, the first ONH series.
The core of the new analyser is the powerful impulse furnace with Eltra’s optimised sample drop mechanism which allows for a wide range of sample materials and sizes: from granules to whole pieces of materials such as steel, copper, titanium or silicon.
The new analyser generation is equipped with a precisely tuned IR measuring system (furnace, catalyst, IR detector) for oxygen determination. Nitrogen and hydrogen concentrations are measured by highly sensitive thermal conductivity cells which provide accurate results even for very low measuring ranges. For the first time it is now possible to use consumer- friendly argon as carrier gas.
The comprehensive software is easy-to-use and offers a variety of diagnosis and analysis tools which simplify routine tasks in the laboratory.
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DISPENSMAN has an innovative, three-position nozzle that controls the dispensing of liquids, the removal of air in the system to avoid liquid loss, and includes an anti-drip safety feature that returns liquid to the bottle. Make volume changes quickly and easily by pushing to unlock and then sliding the volume adjuster to the desired dispensing volume with no need to open bottles, decreasing chances of contamination.
DISPENSMAN is easily calibrated by the user and accommodates most liquids including many acids, bases, and solvents. The system is autoclavable, and does not require consumables such as tips.
Five DISPENSMAN models are available that cover various volume ranges from as low as 0.25 mL up to 50 mL. All meet ISO 8655 specifications. A variety of adaptors are also available that allow the DISPENSMAN to be used with most common bottle types.
For more information on DISPENSMAN bottle-top dispenser, please visit
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New Liquid Handling Website Announced
Dornier LabTech Systems launched a brand new web presence. Get direct access to all information around the PIRO®
www.dornierlts.com.
Pipetting Robot at
“Instead of little cosmetic changes we performed an entire relaunch,” said Michael Duchaussoy, Head of Sales and Marketing. Global customers get information more and more frequent via smartphone and tablet-PC. Therefore this new website is optimised for all relevant displays and browsers.
Dornier LabTech Systems GmbH develops, produces and market premium quality, flexible and easy to use benchtop liquid handling systems Made in Germany. The former aeroplane builder stands for highest quality, precision, and reliability. Service and customer focus are key cornerstones of Dornier’s company philosophy.
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