Method development and validation of dissolution testing. Allschwil, switzerland and horsham, pa, usa, january 2009. Sotax corporation westborough, ma business information. The flexibility of modern uplc systems allows you to automatically screen key method parameters and help to automate your method development experiment. Since then, the importance of dissolution has grown rapidly as have. The design of sotax dissolution systems is compliant with all harmonized pharmacopeia. Sotax laboratory automation world pharmaceutical frontiers. At sotax, we engineer solutions for development and quality control.
Automation of dissolution tests rolf rolli sotax ag basel, binningerstrasse 106, ch4123 allschwil, switzerland. Pharmaceutical testing services provider sotax explores examples of and considerations for automated method development. The at 70smart is driven by the 21 cfr part 11 compliant winsotaxplus advanced dissolution software. The at 7smart is the result of 35 years of development, manufacturing and experience from our customers. Since it takes up a minimum amount of space, it fits into any standard test laboratory. Systems can be configured using baths from pharma test, vankel, erweka, distek, electrolab, hanson, sotax and varian. The sotax at 7smart dissolution tester is the ideal system for automated dissolution. From setup fixed position vessels and autocentering through the complete dissolution test to. The sotax group is an international leader in the development and manufacturing of equipment for dissolution testing, automated sample preparation, and physical testing of pharmaceutical dosage forms. The design of sotax dissolution systems is compliant with all harmonized pharmacopeia requirements for paddle and basket methods. Winsotax software is a 21 cfr part 11 compliant and validated on windows xp2000 software with a high level of data security. Sotax takes over software specialist secom gmbh express. Our experts then assist in finding the most suitable system configuration, help with method development or method transfer if needed and support your team throughout the entire lifecycle of your xtend dissolution system. Sotax has a wide variety of manual and automatic dissolution.
Sotax dissolution system the at md is a fully automated benchtop dissolution system and can handle basket and paddle methods as well as sinkers including japanese sinkers. Read article with this acquisition, sotax group strengthens its portfolio in the data integritydriven field of data management solutions for analytical development laboratories, quality control departments and production sites in the pharmaceutical industry the sotax group has taken over the software specialist secom gmbh to further expand its position as the worlds leading solution. The at md is driven by the 21 cfr part 11 compliant md software. Certification, extended in 1999 to the tickit quality system for software development, thereby becoming the worlds first supplier of dissolution testing systems to. The next generation of dissolution software, winsotax plus, is a now a client. Sotax instruments meet all usp, ep, fda, fip guidelines and most sotax products are in compliance with 21 cfr part 11. The at md is a fully automated dissolution system that fits on your standard laboratory bench. Sotax at 7smart dissolution system with cp 735 piston. Ajay pydah director device development and production. Sotax, founded in 1973, began as an engineering company to service the pharmaceutical and other industries. The at md is a fully automated benchtop dissolution system and can handle. Finding the best solution for your needs starts with one simple question.
Winsotax advanced dissolution software pharmaceutical online. In the event that software is included in an asset sale, notwithstanding the disclaimers set forth above, keith machinery makes no. Today sotax is a leader in the development and manufacturing of test instruments and software for tablet testing and is a leading solution provider for the pharmaceutical industry. We support you with expertise at each step of your process. Sotax dissolution system, model ch4123, sn 011028 va. Sotax dissolution testing fully automated dissolution at md.
With hundreds of systems in operation, the at 70smart is helping pharmaceutical companies worldwide to remain competitive. Sotax group takes over software specialist secom gmbh. Winsotax advanced dissolution software is a 21 cfr part 11 compliant, validated on windows xp2000 software package that controls each of our automated dissolution systems as well as our spectrophotometers. Usp 1092 the dissolution procedure development and validation. Semi automated dissolution testing system sotax india pvt. Reducing cycle times and completing more work with existing resources. Sotax also offers sps pharma services cro, contract research lab dedicated to dissolution testing research, method development and advanced training.
Equipnet is constantly receiving used sotax equipment through our exclusive contracts with our clients. From prerun to postrun system cleaning, sotax streamlines your workflow through the design of features that guide method development and simplify routine operation. At7 smart dissolution testing for usp apparatus 1, 2, 5 and 6, at7 smart dissolution testing for usp apparatus 1, 2, 5 and 6the smarter choice for dissolution testing. The sotax at 7smart dissolution system is designed to determine the invitro drug release from common pharmaceutical dosage forms according to pharmacopoeia requirements. At 70smart fully automated dissolution testing system. It easily handles basket and paddle methods as well as sinkers including large japanese sinkers. Feasibility study secure your instrument investment with data confirmation of fit for purpose method capability on your products method development save time and resources by allowing sotax application scientists to. Winsotax advanced dissolution software controls all sotax dissolution testing systems, as well as, our spectrophotometers. The sotax group is a leader in providing automated dissolution testing systems, sample prep workstations for content uniformity and assay testing, and tablet testing instruments for the pharmaceutical, medical device, biopharmaceutical and dietary supplement industries.
Once a sequence is started, the at md runs up to 8 unattended batches from media preparation to selfcleaning of the system. Sotax flyer at7smart automation system 2006 euro teknokroma. Automated dissolution improves the productivity of a lab creating walkawaytime for operators allowing more time for missioncritical activties such as method development, process validation, data checking, and verification. Dissolution is defined as the process by which a solid substance enters in solvent to yield a solution.
Dissolution testing of drug formulations was introduced in the 1960s and accepted by health regulatory authorities in the 1970s. Dissolution is the process of dissolving the drug substance from the solid state. Builtin firmware for method programming and reporting. Dissolution testing is essential in the formulation, development, and production process for quality control and release in drug manufacturing. Whether you perform dissolution tests occasionally or several times each day argusdissolution will make you more productive in running tests and analy. Sotax introduces winsotax plus a client server dissolution software with improved features. Sotax instruments meet all usp, ep, fda, fip guidelines and most sotax products are in compliance with 21 cfr. Sotaxs mission is to provide high quality and efficient equipment that yields accurate results. Sotax group, worldwide market leader in automated dissolution innovation, launches the new winsotax plus advanced dissolution software. Operated by 21 cfr part 11 compliant winsotax dissolution software alreadyknown and val. Total revision august 2015 usp 1094 capsulesdissolution testing and related quality attributes usp 2040 disintegration and dissolution of dietary supplements ep 2.
Sotax leads the way in the development and manufacture of highquality pharmaceutical testing equipment and associated services. Certification, extended in 1999 to the tickit quality system for software development, thereby becoming the worlds first supplier of dissolution testing systems to receive this seal of quality. Sotax helps pharmaceutical companies worldwide in overcoming the various challenges associated with feasibility studies, method development, method automation, method validation, and method transfer. Sotax instruments meet all cp, ep, jp, usp and fda guidelines and sotax. Using the standard rs232 interface, test temperature, stirrer speed, automated tablet drop and start stop functions can be triggered and monitored from a pc through winsotax advanced dissolution software. Automation within the pharmaceutical industry is a complex process, made even more challenging because the terminology used is inconsistent. Shapes and supports sotax as a member of the sotax usa board conceptualizing and authoring shortlong term strategic plans which prioritize developmental, production, and quality to deliver low. On top of that it also features easy setup and method programming for manual or semiautomated test runs. At7 smart dissolution testing for usp apparatus 1, 2, 5 and 6. The sotax at 7smart dissolution tester is the ideal system for automated dissolution tests based on the stirrer methods. Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution of the drug under physiological conditions, and the absorption across the gastrointestinal tract. Atmd fully automated dissolution testing system youtube. Sotax dissolution system, model ch4123, sn 011028 va 25, 3 component type.
Sotax is well known for their advanced expertise and skills in their field, ensuring consumers are receiving the ideal equipment they need. Uplc can provide the versatility to discover the best set of chromatographic conditions for your sample, providing a more robust method. Automated dissolution testing system sotax india pvt. Sotax at7 smart semiautomated dissolution tester for. The 21 cfr, part 11 compliant qdoc dissolution software from sotax fully integrates the uv7 spectrophotometer. The photometers are completely integrated into the system software. Sotax is a leader in the development and manufacturing of test instruments and software for tablet testing and is a leading solution provider for the pharmaceutical industry.
The dissolution profile is used to demonstrate reliability and batchtobatch uniformity of the active ingredient. March 2014the sotax group, a global leader in the development and manufacturing of dissolution testing, automated sample preparation, and physical testing equipment for the pharmaceutical industry, launches the 4th generation sotax at md fully automated dissolution system. With cameras placed underneath a dissolution bath the user is not only able to see and store real time videos, export pictures or complete videos for future analyses. Sotax is the global leader in providing highquality dissolution testing systems, composite assay and content uniformity workstations and physical tablet testing instruments for the pharmaceutical, dietary supplement, medical device and biopharmaceutical industries. The sotax group is a leader in providing automated dissolution testing systems, sample prep workstations for content uniformity and assay testing, and tablet testing instruments for the. With hundreds of systems in operation worldwide, sotax. For sotax ag, the partnership with the jenabased high tech company is an opportunity to strengthen its position as a leading dissolution systems provider. In 1996 sotax received the iso 9001 certification, extended in 1999 to the tickit quality system for software development, thereby becoming the worlds first supplier of dissolution testing systems to receive this seal of quality. The new at md fully automated dissolution system from prerun to runtime to postrun system cleaning, sotax streamlines your workflow through the design of features that guide method development and simplify routine operation. Sotax dissolution testing smart 10 winsotaxplus dissolution software winsotaxplus has been developed under the latest regulations including gamp, galp, iso 9001 software standards and completely complies with the rules and regulations of 21 cfr part 11 and data integrity set out by the fda. Sotax dissolution system 80002 9150 w cp7 pumpspecifications. Fully automated dissolution testing is defined as several unattended lots run in succession with media preparation. Fully automated dissolution testing system sotax india. This automated tablet dissolution analytical system provides unprecedented performance over and above that of any other hplc or uv dissolution system.
Whether used standalone or in a networked environment, the modern clientserver architecture can be flexibly implemented for different needs. In the pharmaceutical industry, dissolution testing can also be defined as an in vitro laboratory test method that is designed to demonstrate how efficiently an active ingredient is. Discovering the best methods gets you the best results. Our equipment is used worldwide in the development and production processes of our customers and the pharmaceutical and science industries. Customdesigned offline automation system with sample collection, solvent addi.
The sotax group, the global leader in the development and the manufacture of dissolution testing systems, automated sample preparation platforms and physical testing equipment for the pharmaceutical industry, has been working hand in hand with secom for over 20 years. Sotax corporation winsotax advanced dissolution software is a 21 cfr part 11 compliant, validated on windows xp2000 software package that controls each of our automated dissolution systems as well as our spectrophotometers. New sotax at7 smart semiautomated dissolution tester offline automation. Argusdissolution is a scientific dissolution data management software for instrument controle, data acquisition, data management, processing and reporting designed by users for users. With its compact spacesaving design and ease to use, the 7smart features a builtin heatercirculator and staggered vessels for easy sample viewing. Sotax dissolution testing fully automated dissolution at 70smart. Sotax dissolution testing fully automated dissolution at 70smart 7 the at 70smart fully automated dissolution system from prerun to postrun system cleaning, sotax streamlines your workflow through the design of features that guide method development and simplify routine operation.
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