TYPICAL DEVELOPMENT PATH

1. Material Evaluation: A small sample will be requested to evaluate the starting particle size distribution and physical properties such as friability, hardness and feed-ability. The safety of the compound in terms of toxicity, occupational exposure limits (OELs), and explosivity is also evaluated. 2. A non-GMP trial is recommended to provide a low cost, immediate turn-around processing event in which a “proof of concept” sample will be returned to the customer to evaluate the benefit of the milling, micronization or classification service developed in the customers application. Additional outcomes of a non-GMP trial will be estimations of throughput, cost and process parameters required for commercial scale cGMP processing. 3. A GMP production event, will require cGMP documentation to be put into place prior to a production campaign. The documentation will include a Customer Standard Batch Procedure (CSBP) to document the necessary customer, Powdersize and cGMP processing requirements. Additionally, analytical method(s) are transferred to Powdersize for use in post-run cleaning verification.

Flowchart of typical development path