Scale-up technical illustrations

The following roller compaction scale-up examples illustrate technology strategies that identify equipment design features, process parameters, and evaluations defining roller compaction scale-up processes. 

Gereg and Capolla developed process parameters determined by a model laboratory bench scale Carver press, model C (Carver Inc. Savannah, Georgia, U.S.A.), which were translated to production scale compactor parameters (6). Their study provided a method to predict whether a material is suitable for roller compaction. Their study objectives were to characterize properties of the material to identify process parameters suitable to achieve the necessary particle size and density using the dry granulation process and then translate laboratory information to a production scale roller compactor. Actually, information developed from a Carver press was correlated and scaled-up to a production scale Fitzpatrick roller compactor. Model IR 520 (Fitzpatrick Co., Elmhurst, Illinois, U.S.A.) The compactor produced very similar powder granule characteristics as the Carver press. Various lactose materials, available as lactose monohydrate or spray dried lactose monohydrate, were used as the model compounds. Results indicated that a parametric correlation could be made between the laboratory bench Carver press and the production scale compactor, and that many process parameters can be transferred directly. 

The roller compactor s full axial rolls produced compacts in the form of sticks. The unmilled compacts from both machines had the same density, 1.3g/cm. The milled roller compacts produced comparative granules except for bulk density and correspondingly the Carr index values  

The milled compacts generated slightly larger particles where the round slugs produced from the Carver press produced a greater number of fines. The compactor flow rate for the milled roller compacted material was twice as fast as that of the Carver press granules, but both flow rates were deemed acceptable. The authors concluded that both methods produced, for all practical purposes, equivalent granulated material. 

A new antibiotic tablet was introduced internationally in three countries. Two countries did not have compactors to manufacture the product. Their process consisted of the following unit operations  

---