ERWEKA is highlighting the Fully Automated Dissolution System RoboDis II+, a proven parallel‑working dissolution platform that automates every stage of the dissolution process under the control of ERWEKA’s Disso.NET software.
ERWEKA
RoboDis II+ combines a fully automated mechanical setup with integrated digital control to execute all dissolution steps without user intervention, increasing reliability and throughput while freeing scientific staff from repetitive manual work.
RoboDis II+ is engineered to support inspection‑ready operation with integrated System Suitability Tests and a 21 CFR Part 11‑compliant audit trail that continuously self‑checks critical process steps and securely logs user actions, time stamps and test data. The system is fully USP/EP/JP compliant and supports USP methods 1 (basket) and 2 (paddle), allowing quality control and development teams to consolidate pharmacopeia‑compliant testing across global markets on a single platform rather than maintaining multiple, method‑specific setups.
To address space and capacity constraints in modern QC labs, RoboDis II+ delivers high throughput within a compact footprint of up to 2 x 1 meters. A flexible sample magazine for 10, 20 or 40 batches, combined with a parallel‑acting architecture, allows teams to schedule overnight or weekend runs for true 24/7 testing independent of staff presence.
At the heart of RoboDis II+ is a high‑precision Festo robot arm that takes over all routine handling steps within the system, including sample handling, media filling, basket handling and automated vessel cleaning. This robotic precision minimises human error in repetitive operations and ensures that each test is executed in exactly the same way, run after run. Built‑in media preparation with support for up to six media types automates preparation, heating, degassing and supply of dissolution media, accelerating setup and promoting consistent medium quality.
For demanding high‑volume environments, RoboDis II+ uses a ceramic piston pump (PVP) that delivers highly accurate, virtually maintenance‑free dosing and sampling, and supports multiple solid dosage forms and sinkers up to 34 millimetres so laboratories can test tablets, granulates, powders, pellets and sinker‑based formulations on one flexible system. Automatic pH change according to USP Methods A (half‑change) and B (full‑change), with automated pH measurement and documentation, supports complex dissolution profiles that require controlled pH shifts over the course of a test. A USP‑compliant sampling setup with Poroplast inline filters, a valve‑free ceramic piston pump and optional membrane filters via an AFC 825 filter changer enables parallel sampling with temperature measurement in each vessel and multi‑stage filtration when needed, while integrated online UV‑Vis and/or HPLC analytics with automated injection reduce manual analytical work by automating sample transfer and measurement for rapid, end‑to‑end dissolution testing on a single platform.
On the digital side, Disso.NET provides user and role management backed by an MS SQL database and XML‑based LIMS connectivity, combining role‑based access control, secure data storage and straightforward integration into existing IT environments. Laboratories can generate reports and place them on the network while maintaining a complete electronic audit trail, supporting high‑accuracy, reliable testing with short cycle times that help shorten both batch release timelines and development cycles. ERWEKA’s maintenance‑free PVP pump delivers high precision and reliability with minimal downtime, while full automation and 24/7 utilisation allow the system to “pay back” its investment by replacing manual tasks, reducing labor effort and maximising instrument uptime. A comprehensive service concept, including installation with IQ/OQ/AVT, six‑monthly preventive maintenance and requalification, and 24‑hour support, ensures validated startup, sustained performance and rapid response to issues for both QC and R&D laboratories.
With the Fully Automated Dissolution System RoboDis II+, ERWEKA provides pharmaceutical and life science organiations with a mature, field‑proven dissolution platform that automates the complete workflow from media preparation to compliant reporting. By combining advanced robotics, integrated analytics and compliance‑ready digital control, RoboDis II+ helps laboratories streamline dissolution testing, reduce operator dependency and support inspection‑ready operations.