Abstract
This article describes a new approach to optimizing the drug solution preparation process for a production-scale crossflow ultrafiltration system. Equations were proposed to predict the concentration of the active ingredient and the volume of drug solution in the crossflow ultrafiltration process. These equations take into account the residual water remaining in the process line after the set-up of the ultrafiltration system, the residual drug solution remaining in the process line after ultrafiltration, and the residual Water for Injection (WFI) remaining in the process line after WFI rinsing. Because the residual water or residual drug solution varies slightly for each type of production, it was convenient to define them as preparation parameters. Using the proposed equations, testing was performed during early production in order to collect data on the crossflow ultrafiltration process, and the preparation parameters were then optimized. The concentration of the active ingredient and the weight of the drug solution (which was converted to the drug solution volume using its specific gravity) were calculated accurately with the optimized preparation parameter using the proposed equations. These results indicate that the proposed equations and method of establishing the preparation parameters are useful for a production-scale crossflow ultrafiltration system.
Footnotes
- Copyright © Parenteral Drug Association. All rights reserved.
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.