ERWEKA Offline Dissolution Testers Overview
ERWEKA offline dissolution testers are automated sampling systems controlled by a DT 950 digital dissolution tester with fraction collector. The ERWEKA DT 950 series offers advanced intelligence and features for stand-alone operation or for control of the dissolution offline sampling system. With the updated TestAssist, the user can easily configure and start dissolution tests with automated sampling on our 7“ touch display. The design principles first introduced with the DT 950 have been applied to offline testing, making it as fast, easy and error-proof as never before. The user is guided through the dissolution test with automated sampling in few simple steps, enabling 100% USP/EP/JP compliant dissolution testing without distraction and errors and ensuring constantly compliant parameters.
With the new user management, user-based control of the complete offline system is only a button-tap away. Users can be easily configured with individual rights, making it easy to restrict functions only to authorized users – for example Administrators, Operators and Service technicians.
Fully CFR Part II software is also available for this bath upon request (click here for more).
DT 950 dissolution testers come with integrated intelligence for controlling the offline sampling system, which consists of a auto-sampling station connected to the DT, an 8 or 16 channel peristaltic pump and the sample collector FRL 824 for storing the samples into glass tubes or sealed HPLC vials.
This configuration does not require an additional PC or any software and therefore saves space, money and last but not least software validation work.
Automated Sampling Station
The ERWEKA automated sampling station ASS-8 with automatic height adjustment takes into account the applied method and the used media volume. Similar to manual sampling the tubes are inserted into the media only for sampling time needed and withdrawn after sampling is finished. Since this system adheres to USP requirements and cross validation is not required.
Peristaltic Pump IPC
With the standard ERWEKA 8-channel peristaltic pump IPC the sample is withdrawn from the dissolution tester vessel and transferred to the sample collector FRL x24. The pump tubings are made of Verderprene (similar to Fluoropolymer) to prevent the absorption of active ingredients. Alternatively a high pressure piston pump PVP 620 or 820 (6 or 8 channels only) allows filtration from 0.22 μm. With a high precision syringe pump type SP automated dilution of the sample in ratio up to 1:10 is possible.
Sample collection with the FRL
Dosing is performed by overfilling and levelling or 3-way solenoid valves incorporated into the sample collector FRL 624 / 724 or 824 with 6, 7 or 8 channels. There are several sampling possibilities of max. 26 sampling intervals into glass tubes or glass tubes and sealed/unsealed HPLC vials as well as media replacement.
- Easy access to sample tubes
- Easy to clean
- Up to 26 rows for extended release formulation testing
- Integrated cleaning procedure
- Needles available in stainless steel or titanium for sensitive APIs, HPLC vials and glass tubes
- Special procedure for foaming medias handling
- Automated flush routine between sampling intervals
- Gentle and precise spindle drive of the sample collector FRL
- Movable trays provide easy exchange of different racks
- Different racks available for glass tubes or HPLC vials
14 Vessel Offline Systems with DT 9510
In combination with the 14 vessel DT 9510 range of dissolution testers, the automated sampling and media replacement can be performed in 14 vessels simultaneously. In this case a peristaltic pump IPC-16 is included in the system.