Dissolution testing software for pharmaceutical industry
Optimize dissolution testing with advanced software that manages data collection, analysis, and compliance, ensuring precise and reliable results in pharmaceutical research and quality control processes.
Controls and Manages Dissolution Testing Data
WinSOTAX®plus from SOTAX is an adaptable dissolution data management system tailored for the rigorous demands of pharmaceutical and biotech applications. This system offers precise control over dissolution testing, making it essential for comprehensive analysis and regulatory compliance. It supports a variety of product forms, including tablets, capsules, and injectables. WinSOTAX®plus integrates seamlessly into both semi-automated and fully automated environments, ensuring streamlined operations across R&D and QC departments. Featuring a centralized SQL database, this system enables both stand-alone and networked operations, providing real-time data capture and reporting. With full compliance to 21 CFR part 11, it supports meticulous data management through user-group configurations and customizable report setups. Optionally available in configurations suitable for various chemical environments, it ensures durability and longevity. Cleaning and maintenance are simplified through its streamlined design, while customization options provide tailored solutions to meet unique testing needs.
Benefits
- Enhances data integrity and security in pharmaceutical testing with 21 CFR part 11 compliance.
- Optimizes laboratory productivity through seamless integration from semi- to fully-automated systems.
- Facilitates compliance with real-time data capture and user-group specific reporting.
- Reduces operational inefficiencies by supporting networked and stand-alone configurations.
- Customizable solutions cater to specific testing requirements, increasing versatility across applications.
- Applications
- Medical devices,Gels,Pellets,Granules,Microspheres,Catalysts,Stents,Food,Nano suspensions,Fine chemicals,Coated lenses,Soft-gelatin capsules,Implants,Animal health,Capsules,Powders,Washtabs,Transdermal patches,Creams,Suppositories,Semi-solids,Bottles with screw caps,Apis,Tablets,Injectable suspensions
- End products
- Multivitamin capsules,Industrial catalysts,Sustained-release pellets,Orthopedic implants,Insulin injectable suspensions,Pharmaceutical-grade gelatin,Liposomal nano suspensions,Antiseptic gels,Glycerin suppositories,Omega-3 soft-gelatin capsules,Anti-reflective coated lenses,Protein powders,Effervescent granules,Dishwasher washtabs,Nicotine transdermal patches,Moisturizing creams,Analgesic tablets,Active pharmaceutical ingredients (apis) like ibuprofen,Vitamin bottles with screw caps,Coronary stents,Animal health supplements,Biodegradable microspheres
- Steps before
- Media Preparation,Sample Preparation,Formulation Development
- Steps after
- Data Analysis,Reporting,Result Documentation,Quality Control
- Input ingredients
- tablets,capsules,pellets,APIs,powders,granules,soft-gelatin capsules,suppositories,medical devices,stents,implants,microspheres,nano suspensions,injectable suspensions,semi-solids,gels,creams,transdermal patches,washtabs,fine chemicals,catalysts,food,animal health,coated lenses,bottles with screwcaps
- Output ingredients
- dissolution data,percent dissolved,abs,concentration,calibration results,UV-Vis sampling reports,flow rate data,temperature reports,compliance documentation,audit trails,real-time data collection,customized reports
- Market info
- Sotax AG is renowned for its expertise in manufacturing high-quality pharmaceutical testing equipment, including dissolution testing systems, and has a strong reputation for reliability, precision, and innovation in laboratory and industrial applications.
- Dissolution Tester Types
- USP 1/2/5/6/4
- Automation
- Semi-automated to fully automated
- Data Collection
- Real-time in percent dissolved,abs,or concentration
- Analysis Functions
- Single or multi-component analysis and scanning
- Calibration
- Standard calibration and standard bracketing
- Flow Rate Reporting
- Available
- Temperature Reporting
- Available
- Sampling Control
- UV-Vis sampling timepoints and sample volume collections
- Compliance
- 21 CFR part 11
- Database Type
- Centralized SQL database
- Operation Type
- Stand-alone and networked operation
- Automation level
- Semi-automated / Fully automated
- Data collection
- Real-time
- Control system
- User-friendly / Centralized SQL database
- Batch vs. continuous operation
- Batch
- Cleaning method
- Manual
- Compliance
- 21 CFR part 11
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- 21 CFR part 11
- Compliant
- FDA compliance
- Likely compliant
- Control panel type
- User-friendly method setup
- Integration possibilities
- Single or networked operation
- Database integration
- Centralized SQL database