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Dissolution Software is used to ensure data integrity for laboratory analysts working with USP dissolution apparatus. Check out the frequently asked questions and find out how Dissolution Workstation Software supports digital transformation of release-rate testing for drug dosage formulations.
Agilent Dissolution Software enables unique user access rights to be defined. All user access and user events are tracked, date and time recorded, and this data stored in a secure database. The documented events create a secure audit trail that is read only.
A laboratory manager with full administrative rights can specify user access accordingly. Managing user access helps to:
• Restrict access to dissolution methods
• Control operation of dissolution apparatus
• Enable only certain users to create and edit dissolution methods
• Assign authority levels to electronic signatures (eSignature)
• Prevent systems, method settings, and data from being manipulated or compromised
Agilent Dissolution Workstation Software allows for individually customized user permission. The customization means that user access can be tailor-made to every analyst and laboratory environment. For QC laboratories performing high-throughput dissolution testing, the data integrity afforded by Dissolution Workstation Software is invaluable.
Primarily, Dissolution Workstation Software ensures data integrity of dissolution tests when performing release-rate testing on drug dosage forms. Second, the software supports lean thinking and agile work practices in research and development (R&D) and quality control (QC) laboratories.
Formulation chemists working in R&D can track changes to dissolution methods during development. Once a formulation is released to manufacturing, the final dissolution method can be electronically shared with analysts in the QC laboratory for efficient batch testing. Here are 11 reasons to buy dissolution software:
1. Organizes all user dissolution methods and test data
2. Enables complete operational control and automation
3. Offers structured user-level permissions and access
4. Configurable to suit all laboratory users’ needs
5. Gives the ultimate flexibility with control
6. Maximizes sampling in any 24-hour period, and longer
7. Relieves users from being bound to the bench
8. Satisfies regulatory requirements for data storage and traceable digital records
9. Ensures data integrity and digital security (supports 21 CFR part 11)
10. Curates a digital ecosystem of dissolution knowledge
11. Supports troubleshooting and reduces investigation effort
Agilent Dissolution Workstation Software operates all the primary apparatus listed in the United States Pharmacopeia (USP) and harmonized pharmacopeia. Test methods and operational control are accessed following successful login to the software. After login, manual or automated sampling is possible, giving operational flexibility as well as data integrity.
Agilent dissolution apparatus includes:
• 708-DS Dissolution Apparatus (USP Apparatus 1, 2, 5, and 6)
• BIO-DIS II Dissolution Apparatus (USP Apparatus 3)
• The Reciprocating Holder (USP Apparatus 7)
• 400-DS Dissolution Apparatus (small volume Apparatus 7)
• NanoDis System (nanoparticle dissolution testing)
When using Apparatus 1, 2, 5, or 6, all dissolution paddle, basket, rotating basket, and rotating cylinder accessory serial numbers can be electronically recorded. As a result, test reports can include all accessories used for each dissolution run. The Agilent Dissolution Workstation Software can be used to automate the 708-DS Dissolution Apparatus when combined with the 850-DS Autosampler. The Dissolution Workstation Software is always used to operate the small volume Apparatus 7 (400-DS Dissolution Apparatus).
Because dissolution testing uses large volumes of liquid, spillages are common. Using Dissolution Software helps keep the bench area clear of paper and notebooks. Bench space is reclaimed and spillages on paper documents are no longer a concern.
Using Dissolution Workstation Software also frees up precious time from mundane tasks. Repetitive documenting and transcription of tester details is eliminated. Plus, the occurrence of transcription mistakes by human error is also reduced.
Audible and visual alarms notify busy laboratory analysts of when to take dissolution samples. The automated alarms mean that analysts can be relieved from constantly watching the clock. The time between sampling can now be used to perform other essential tasks. Dissolution Workstation Software helps laboratory managers optimize workflows, be lean, and be paper free. And it helps busy analysts successfully keep an efficient laboratory operating effectively.
Yes. The Agilent 280-DS Mechanical Qualification System for Dissolution Apparatus 1 and 2 is a user-friendly system. Dissolution Workstation Software guides the user with prompts to select the method and apparatus for the required test. Users can:
• Select paddle or basket shaft type
• Specify the active positions to be measured
• Review pretest parameter and tolerance settings
• See ‘as found’ online readings
• Monitor each parameter during the test
• View any out-of-specification results in real time
• Include documented comments to each test report
• Update the qualification due date
If an error occurs during the test sequence, the user can cancel the test. A reason must be provided and is documented for compliance purposes. A software-generated final report is automatically stored in the secure database. This report can also be printed or exported as a PDF. A technical overview of the Agilent 280-DS Mechanical Qualification System can be read here.
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