RT Journal Article
SR Electronic
T1 In Situ Monitoring of Soil Dissolution Dynamics: A Rapid and Simple Method for Determining Worst-case Soils for Cleaning Validation
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 203
OP 214
VO 58
IS 4
A1 Sharnez, Rizwan
A1 Lathia, Justin
A1 Kahlenberg, David
A1 Prabhu, Sunil
A1 Dekleva, Michael
YR 2004
UL http://journal.pda.org/content/58/4/203.abstract
AB A common approach utilized in validating the cleaning of multi-product equipment is to challenge the cleaning cycle with the hardest-to-clean, or “worst-case”, soil. The worst-case soil is often determined through bench-scale experiments. These experiments can be tricky and time-consuming, especially when the dissolution dynamics of the soils are characterized by crossovers beyond the limit of visual detection. This paper describes a simple in situ method for monitoring soil dissolution dynamics and rapidly determining worst-case soils for cleaning validation. The method utilizes the real-time response of electrical conductivity to identify crossovers and to determine the optimal time for endpoint analysis. The results address the sensitivity and reproducibility of the method and the identification of critical experimental parameters. The dissolution dynamics of several parenteral products are compared.