Self-cleaning dissolution tester for automated series testing

Achieve unparalleled precision in dissolution testing with an automated system that minimizes hands-on intervention, ensuring consistent and reproducible results across multiple test runs while maintaining stringent compliance with pharmacopeia standards.

The ATF Xtend™ Offline Dissolution Tester from SOTAX revolutionizes your laboratory workflow by implementing a fully automated, self-cleaning system that meticulously manages dissolution testing. This equipment excels in integrating dissolution testing, media preparation, and sample collection, optimizing processes across R&D and quality control environments. Suitable for applications ranging from pharmaceutical tablets to medical device coatings, it ensures precise and reliable results.

Equipped with an integrated media preparation module, the system prepares, heats, and degasses media using various recipes. The high-precision piston pump and automated filtration system support efficient HPLC/UPLC analysis by accommodating filters down to 0.2 microns. The system’s compliance with USP, Ph.Eur., and other pharmacopeias assures 100% traceability and repeatability, making it ideal for maintaining standards in pharmaceutical manufacturing and biotechnology.

Designed for efficiency, the self-cleaning dissolution tester reduces the need for manual intervention, enabling continuous operation with no operator-required vessel removal for cleaning. Additionally, the q-doc® data management software ensures data integrity while adhering to 21 CFR part 11 compliance. With customization options and engineering support available, the ATF Xtend™ Offline is engineered to cater to the specific needs of pharmaceutical manufacturers, R&D labs, and biotech firms.

Benefits

  • Enhances laboratory productivity by allowing uninterrupted, unattended operation.
  • Ensures consistent and reliable results with automated, repeatable testing processes.
  • Minimizes maintenance efforts and downtime with a self-cleaning system.
  • Meets stringent compliance requirements, ensuring alignment with industry standards.
  • Safeguards data integrity through robust, 21 CFR part 11-compliant data management.
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,Apis,Tablets,Injectable suspensions
End products
Fish oil soft-gelatin capsules,Vitamin d capsules,Dental implants,Omega-3 supplements for animal health,Anti-aging face creams,Pharmaceutical catalysts,Nicotine transdermal patches,Injectable insulin suspensions,Antifungal gels,Paracetamol suppositories,Dishwasher tablets,Paracetamol tablets,Scratch-resistant coated lenses,Drug-eluting stents
Steps before
Media Preparation,Heating,Degassing
Steps after
Sampling,Filtration,Cleaning,Gravimetric Verification
Input ingredients
dissolution media,tablets,capsules,pellets,API's,powders,granules,soft-gelatin capsules,suppositories,medical devices,stents,microspheres,nano suspensions,injectable suspensions,semi-solids,gels,creams,transdermal patches,washtabs,fine chemicals,catalysts,food,animal health products
Output ingredients
dissolution samples,filtered samples,collected samples,capped LC vials,wellplates,test tubes,HPLC analysis,UPLC analysis
Automation
Fully automated
Self-Cleaning
Yes
Filtration Precision
0.2 microns
Sample Collection
Up to 60 timepoints
Media Preparation
Automatic heat and degas,pH change
Vessel Volume Verification
Gravimetric
Data Compliance
21 CFR part 11
Compliance
USP,Ph.Eur.
Cooling
Flow-through rack cooling
Degassing Method
Helium sparging/vacuum
Automation level
Fully Automated
Batch vs. continuous operation
Batch
CIP/SIP
Self-cleaning
Cleaning method
Automated Vessel Cleaning
Traceability
Automatic Execution and Recording
Repeatability
High Precision
Sample Collection
Automated up to 60 timepoints
Cleanability
Self-cleaning
Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm
USP Compliance
USP 1/2/4/5/6
Machine footprint
Compact
Control panel type
HMI with touchscreen interface
Sample collection format
Test tubes,capped vials,or wellplates
Compliance software
q-doc® software with 21 CFR part 11 compliance
Video monitoring
CenterView™
Robotic automation
RS robotic station for basket exchange and sinker retrieval
System modules
Integrated MP-F,CP-F,FS-F,CS-F modules
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.