For DI compatibility of dissolution testing machines! Workstation software (DWS)
Management of test data, data integrity, dissolution testing software!
Since 2015, guidance on data integrity (DI) has been issued by the MHRA (UK Medicines and Healthcare products Regulatory Agency), WHO, FDA, and PIC/S, and its importance has been increasing in recent years. DI is defined as "the completeness, consistency, and accuracy of data. Data that is complete, consistent, and accurate is recorded with attributes of traceability, legibility, and contemporaneity, and is either original data or a true copy, and is accurate." It also ensures that pharmaceuticals meet the required quality standards. DWS is the optimal software for ensuring data integrity in dissolution testing. It supports access management, data tampering prevention, and backup, allowing for the management and control of dissolution testers and their peripheral devices with just this one software, making complex methods and data management easier to handle.
basic information
To ensure data integrity in dissolution testing, the introduction of the Agilent dissolution testing workstation is optimal. ● Compliance: 21 CFR Part 11 compliant ● Security: Access management, tamper prevention, audit trails, backups ● Efficiency: Control and data management for up to 4 dissolution testers
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Model number/Brand name
Dissolution Test Workstation Software (DWS)
Applications/Examples of results
Purpose: Control of multiple dissolution testers using software. Monitoring of bus & vessel temperature, paddle rotation speed, vibration, and sampling time. Tamper prevention for password, user permissions, audit trails, etc.
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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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We will be exhibiting at Interfex Week 2019!
We will be showcasing our products at the booths of various manufacturers. Please feel free to stop by when you visit the venue. We look forward to your visit. <Exhibitor: Evonik Japan Co., Ltd.> Exhibition: 21st Interphex Japan Booth Number: W20-29 [Main Products] Functional Polymer EUDRAGITⓇ Please consult us regarding formulation design, scale-up services, and oral DDS. <Exhibitor: Agilent Technologies, Inc.> Exhibition: 1st Pharma Lab EXPO Booth Number: A18-4 [Main Display Products] Dissolution Tester 708-DS (USP Apparatus 1/2/5/6) This device features excellent operability with automatic height adjustment and automatic tablet insertion, along with a robust design that excels in mechanical calibration compliance. Data Integrity Compliant Software This software is ideal for ensuring data integrity in dissolution testers, with features such as access management, data tampering prevention, and backup. [Information on Booth Presentations] During the event, we will hold a presentation at our booth on "Digitalization of Data Related to Dissolution Testing."
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Starting as an import trading company in 1927, we have been developing our business with many overseas suppliers and domestic customers over the years. Through our services of connecting the two together, Higuchi has become the well trusted "Japan distribution channel" for suppliers, and the "dependable vendor" who provides a stable supply of the latest high-valued overseas products to customers. Today, we conduct not only importing but also exporting businesses, trilateral trades, and overseas business investments as well. We have also expanded to local subsidiaries in the United States and China, to which we are able to effectively network overseas. Higuchi believes in the criticalness of providing a stable supply to customers, and we also place the highest priority on the coexistence with suppliers, to whom we can mutually develop together in a long-term perspective. Your support and consideration to our corporate philosophy would be much appreciated.