Drying Scale-down Laboratory Kit

Pharmaceutical Drying: Design and Manufacturing of a Drying Scale-Down Laboratory Kit

Would you be able to share some further details on what is meant by compaction force ? Are you referring to the effect of the smoothing feature of the agitator blade when ran over a cake surface ? Are you referring to the effect of pressure filtration stage (with cake smoothing) on the cake ? Other ?
- ANSWER: We define the compaction force as the force exerted by the powder on itself. Since thicker and wider cakes are expected at plant scale, high compaction forces are created by top layers of cake on bottom layers. These forces combined with shear forces due to agitation are expected to result in breakage and attrition. The compaction forces are recreated in the lab scale by adding extra weights on top of the cake.

Would the equipment need to be able to perform fully automatically the testing through pre-set recipes, i.e. a need for automation valves, flow controllers, pressure regulators, etc… or would this remain more of a manual process via SOP ?
- ANSWER: The initial ask is to be the main unit: the filter dryer and its components which are the agitation system and the added weights. As mentioned in the RFP, the kit should include ports to be used as needed (PAT, thermocouples etc.…) and should be jacketed for temperature control.

Have you identified already what type of parameters you would want to monitor ? Pressure, Differential Pressure, Flow rates (filtrate out, purge gas in ?), speed, torque, etc… ?
- ANSWER: Yes, drying rate will be likely determined by Mass Spec analysis of the effluent gas. We expect to monitor the cake temperature to inform about drying evolution within the cake. Filtration rate cake be determine using an add on balance and is out of scop of this project.

Are you looking to record this data ? If so to what frequency of sampling (10s, 1s, 1min ?). Can this data be stored in .csv format ?
- ANSWER: The only data record required with the unit is torque measurement (although it can be added later on). The frequency of sampling depends on the drying kinetics, but based on experience, sampling time of 30s to 10min is preferred. Other data recording is out of scope of this project as it will be set by the add-on accessories (MS, Temp. Mass of filtrate)

Would the equipment need to communication with other surrounding equipment ?
- ANSWER: Yes. The unit will be connected to a temperature control bath (it has to have a double jacket). In addition and mentioned in answer to Q2. The core unit should be equipped with sampling ports to plug in various probes. It is recommended that the unit has a sight window and an internal lighting.

If the topic can only be discussed officially in writing, can you clarify what is expected from vendor/PSL in terms of documentation, technical detail, etc… to assess what we can offer ? Are you looking to run this project through the means of a Front End Design (FED) where concepts and designs are reviewed and adjusted, before a formal equipment cost can be put forward ?
- ANSWER: It depends on time budget required for the FED. In my view, a rough estimate of the cost of a feasibility study and the building of the prototype is needed at this time. If there is a risk of a significant change in cost between an estimate with and without and FED, then I think that an FED is needed. However, I leave it up to the ETC secretariat to provide a final answer.