Application of the Discrete Element Method (DEM) to Understand a Powder Blending Process and De-Risk Scale-up

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
AIChE Annual Meeting
October 30, 2012 - 1:45pm-2:10pm
Scale-up of batch manufacturing operations in the pharmaceutical industry often presents technical challenges and various risks.  In this work, a case study describing the use of a discrete element method (DEM) model to  study a batch blending process is described.  This model was developed to (1) gain insight into undesirable blend uniformity results observed during the manufacture of a recent drug product registration batch and (2) to assess the risk associated with scaling-up the process.  During execution of the pilot-scale registration batch, the team had observed the presence of a sub-potent region of the blend that was insufficiently mixed in addition to variability in the potency of stratified samples.  The model has confirmed that poor blending is to be expected in this particular bin and visually depicts the presence of a “dead zone” where mixing does not occur due to the particular processing conditions used in the operation of this blender.  The model also revealed that, by employing certain modifications to the process, a uniform blend could be achieved in this equipment.  To assess the risk in scaling-up this process, the blending performance in the commercial scale bin was predicted to be satisfactory.  Results from the commercial scale batch confirm that a well-mixed blend is in fact achieved in this equipment.  The use of process models such as this enable scientists and engineers to better understand the process and the associated risks which help to enable successful drug product development and scale-up.
Professional Development Hours
0.5 PDHs
You will be able to download and print a certificate for these PDH credits once the content has been viewed. If you have already viewed this content, please click here to login.
Presenter(s): 

Would you like to access this content?

No problem. You just have to complete the following steps.

You have completed 0 of 2 steps.

  1. Log in

    You must be logged in to view this content. Log in now.

  2. Purchase Technical Presentation

    You must purchase this technical presentation using one of the options below.
    If you already purchased this content recently, please click here to refresh the system's record of ownerships.

Pricing

Credits 0.5 Use credits
List Price $25.00 Buy now
AIChE Members $15.00 Buy now
AIChE Undergraduate Student Members Free Free access
AIChE Graduate Student Members $15.00 Buy now
Related Topics: