The cleaning of the PTS Batchmixer® is carried out the same way as the mixing process itself. Cleaning liquid is transferred b PTS Powder Transfer System® which is equipped with a liquid separator to clean the filling line and the liquid is then circulated in order to eventually clean the circulation line.
The upper part of the system contains a spray nozzle guaranteeing thourough cleaning of both the dome and the deflector.
The system can be dried in a very short time by vacuum without the need of hot air.
PTS Batchmixer® SIP
PTS Batchmixer® is designed according to latest cGMP requirements without internal parts or inaccessible areas thus allowing the system to be sanitized or sterilized with either 90° C hot water or steam.
The system is equipped with various temperature probes for temperature mapping and with a steam trap valve in the lowest part of the mixer.
The vessel is insulated to prevent the cleaning media to come into contact with the vessel wall and to keep the heat loss reduced to a minimum.
PTS Batchmixer® can be fitted with load cells in order to check the dispensed weight as well as the complete discharge of the system.
Combined with specific dosing valves in the transfer line controlled by the PTS system, it is feasible to have a fully automated dispensing system directly from the powder discharge stations or from the process equipment to be emptied.
High Shear Propeller
For products requiring shear forces to achieve proper mixing results, the mixer can be equipped with a high shear propeller in the lower part of the vessel right before the circulation line.
The typical speed of the propeller is between 400 and 800 rpm and can be adapted by a variable speed controller according to the product requirement.
The propeller location in the lower part of the system is optimal as all of the product passes this area during the circulation.
Validation of the mixing efficiency is a must for quality control. In the absence of PAT technology, it is required to take physical samples out of the mixer.
This is often a challenge when handling potent materials as it is not acceptable to open the system.
Dec provides a fully contained solution to take samples with the MPTS Sampling Device directly from the circulation lines.
The system is fully automated and synchronized with the Batchmixer operation taking samples at determined intervals.
For processes requiring a very high dilution rate with the addition of small powder quantities for instance for a concentration of less than 0,1 %, it is recommended to add this minor ingredient directly in the circulation line and not in the upper part of the PTS Batchmixer® as it could remain on the vessel wall.
Depending on the quantities to be charged, PFL Powderflex can be used to continuously inject into the circulation line the ingredient during the mixing process thus permitting a predilution in the line before the final homogenization in the mixer.
Process Analytical Technology
PAT can be used to validate the mixing efficiency in line by means of a real-time SWIR spectrophotometer which is installed in the circulation line.
The technology is not intrusive without disturbing the powder circulation or adding cleaning issues.
Chemometric predictive models must be developed in order to accurately determine compositions and the endpoint of the blending process.