Automatic dissolution tester CE 7smart Offline

fully-automaticfor medical researchfor in-vitro drug release

Product overview
CE 7smart Offline is a flow-through cell dissolution testing system designed to automatically collect dissolution samples offline. The system collects samples from a constant flow using a splitting valve; fluid is pumped with a CP pump and filtered through a circular filter located in the flow-through cell head before being stored in an autosampler (C613 or C615). The CE 7smart supports both open and closed loop configurations and enables controlled hydrodynamics for reproducible dissolution testing.

Benefits

• COLLECT – Collect dissolution testing samples in tubes or vials
• CONTROLLED – Controlled hydrodynamics for reproducibility
• OPEN – Open loop configuration with infinite sink conditions and automated pH changes
• CLOSED – Closed loop configuration with fixed volumes (15 - 4000 mL) for compendial low-volume dissolution
• IVIVC – Simplified in-vitro/in-vivo correlation using open loop operation
• ADAPT – Test APIs, oral, topical, parenteral and subcutaneous formulations reproducibly
• CLEAN – Automated cleaning procedure

Highlights
Simple and efficient: collecting dissolution testing samples offline automates sampling while preserving consistent sample treatment. A splitting valve directs the sample flow, the CP pump delivers media and sample flow, the sample is filtered via a circular filter in the cell head and stored in autosamplers C613 or C615. Consistent handling improves data reliability.

From API to novel dosage forms: the CE 7smart expands experiment design for reproducible testing of APIs, intermediates and final dosage forms, providing relevant data for pre‑formulation, characterization, IPC and QC testing.

Biorelevant methods: compatible with biorelevant media (levels 0–3). The CE 7smart enables on‑the‑fly pH changes for extended and delayed release testing and is suited for poorly soluble compounds (BCS class II and IV).

Volume flexibility: users can adapt open and closed system settings to solubility and sensitivity needs, adjusting media volume while maintaining the same hydrodynamic conditions across volumes (closed-loop fixed volumes 15–4000 mL; flexible operation 50–5000 mL as documented).

Testing subcutaneous injectables: BioJect™ is a specialised cell to assess drug release of subcutaneous injectables. Built on a compendial dissolution setup, the 22.6 mm ID cell supports a hydrogel-based reservoir (agarose) for controlled pore size and diffusion behaviour.

Options & related modules

• Autosamplers: C613, C615 (sample storage)
• Software: WinSOTAX®plus dissolution data management and reporting

Technical specifications

• Model: CE 7smart (Offline configuration)
• Technique: Flow-through cell dissolution tester (USP 4 technique)
• Sample collection: Offline collection into tubes or vials via splitting valve; filtered through circular filter in the flow-through cell head
• Pumping: CP pump used to deliver media and sample flow
• Autosamplers: C613 or C615 for sample storage
• Configurations: Open loop (infinite sink, automated pH changes) and Closed loop (fixed volumes for compendial low-volume dissolution)
• Closed-loop fixed volume range: 15 - 4000 mL
• Volume flexibility: adaptable operation from 50 to 5000 mL while maintaining hydrodynamic conditions
• Biorelevant compatibility: supports biorelevant media levels 0–3; enables on-the-fly pH changes
• Applications/dosage forms: APIs, oral, topical, parenteral and subcutaneous injectable formulations
• BioJect™ cell: specialised cell for subcutaneous injectables; 22.6 mm internal diameter; supports hydrogel-based (agarose) reservoir for controlled pore size and diffusion
• Cleaning: automated cleaning procedure available
• Accessories/modules: splitting valve, circular filter in cell head, CP pump, autosamplers (C613/C615), WinSOTAX®plus software
• Intended uses: pre-formulation, characterization, IPC and QC dissolution testing; suitable for poorly soluble compounds (BCS II/IV)