Dissolution Tester Mechanical Calibration System 280-DS
JP17 Bureau Reference Information: Mechanical Calibration Correspondence for Dissolution Test Apparatus
The 280-DS MQS measures the parameters of mechanical calibration of dissolution testers with high precision. Measurement is done hands-free thanks to sensor technology, taking only about 30 minutes per unit. It complies with 21 CFR Part 11. ★ Mechanical calibration has been included as reference information in the 17th edition revision. "To aim for reduced variability in test results through mechanical calibration, it is recommended to apply this reference information." (From the 17th Japanese Pharmacopoeia revision "Standard Methods for Mechanical Calibration of Dissolution Testers")
basic information
Effects of introducing 280-DS MQS: - Shortened MQ tasks (2 days to 30 minutes) - Reduced calibration intervals, improving the reliability of test results - Equipment history can be investigated - Measurement results are automatically recorded from each module to the PC - Standard tablets such as prednisone are not needed
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Thank you for visiting the 6th Bio Pharmaceutical EXPO at Interphex Week Tokyo.
Thank you very much for visiting our booth at the "INTERPHEX Week Tokyo - 6th Bio Pharmaceutical EXPO" held recently. Thanks to your support, we were able to conclude the event successfully. If you have any questions regarding the products you viewed, please feel free to reach out to us. We will respond to the inquiries received during the event in due course. We appreciate your continued support of Higuchi Shokai. 【Exhibited Products】 - Sterile Capsule Filter Asepti Series (Advanced Microdevices) - Assembly Tubes and Bags (Advanced Microdevices, WHK BioSystems) - 3D Printer for Solid Dosage Manufacturing M3DIMAKER (FabRx) - Dissolution Testing Paddle Method/Basket Method 708-DS for Nanoparticle Formulations (Agilent Technologies)
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[Announcement of Webinar] Agilent Pharma / Biopharma Virtual Summit 2021
We would like to introduce a live webinar hosted by Agilent Technologies. In December 2020, and in January and February 2021, a series of webinars focused on pharmaceutical analysis, ranging from small molecule drugs to biopharmaceuticals, will be held. In December, the theme will be "Small Molecule Drugs and Nucleic Acid Medicines (Active Ingredients - CMC - Quality Control)," and we will present on "Automation of Dissolution Testing and Regulatory Compliance Software." The seminar will introduce the automation of dissolution testers through auto-sampling, compliance with data integrity, and the nanoparticle dissolution testing system "Nano Dis."
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Notice of Interfex Week Osaka Exhibition
We will be exhibiting at "Interfex Osaka" in February!! This time, we will have a booth showcasing many new release products. Additionally, we will be displaying related products regarding the management of testing and manufacturing data, which is a recent trend, so please stop by. <Highlights of New Release Products> ▶ Polarimeter compatible with JP, USP, and ChP ▶ Tablet testing machine compliant with Part 11 ▶ Benchtop granulation equipment ▶ Dynamic flowability testing device, etc. <Data Management Products> ▶ Dissolution testing management system ▶ Mechanical calibration system for dissolution testing apparatus ▶ Dissolution testing camera system ▶ Management system for tablet pressing mortars and pestles
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[Seminar 3/15] Announcement of the Practical Seminar on Dissolution Testing
We will be holding a seminar focused on mechanical calibration and data integrity (DI) in relation to dissolution testing of formulations, which has recently garnered significant interest. Mechanical calibration, newly included in the reference information of the 17th revision of the Japanese Pharmacopoeia, has become well-known as a qualification evaluation method using a different approach and is being implemented by many companies. Additionally, there has been a longstanding requirement for the data generated from each process to be complete, and specific guidelines, including draft versions, have now been provided by various countries and organizations regarding DI. This seminar will include demonstrations and explanations related to mechanical calibration. We will also cover an overview of DI and its relationship with dissolution testing. We hope that by attending this seminar, participants will find it helpful in terms of future implementation, resolving issues, and deepening their knowledge. Seminar Content: - Qualification evaluation of dissolution testing equipment - Differences in mechanical calibration content between the Japanese Pharmacopoeia and various organizations - Practical training on mechanical calibration - Information on data integrity - Introduction to the equipment we handle
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We exhibited at the 31st Interphex Japan!
Thank you very much for visiting us during the event. Thanks to your support, we were able to conclude the event successfully. We sincerely appreciate it on behalf of all involved. We will respond to the inquiries received during the event in due course. Additionally, for inquiries regarding exhibited products or other products, we would be grateful if you could contact our sales representative or reach out via the "Contact Us" section at the top of our website. We look forward to your continued support. [Main Exhibits] Agilent Technologies 708-DS Dissolution Tester, BIO-DIS Dissolution Tester, 280-DS Mechanical Calibration System, Dissolution Testing Workstation Software (DWS), Inspector 500 Portable Raman Spectrophotometer, Work Assistance Robot (Reference Exhibit)
