The unfortunate truth is, there are many "filtration scientists" out there who care more about the top line than supporting the industry using filtration.
Here a prime example from a PDA Interest Group Meeting (also supposed to science based):
"XYZ company tested a variety of its own and competitors’ filters, and Mr. X offered the following suggestions for addressing the surface tension issue. Consider, he said:
a tighter filter (0.1 µm if possible, he said)
serial (bioburden reduction) filtration
double sterilizing grade filtration
filtration prior to product formulation"
Three suggestions, which just will increase the sales of the filter vendors. How about showing the surface tension results, determining why surface tension increase the risk of microbial penetration, determine the critical process parameters and list them. The filtration industry should use meetings like this to synchronize their data and find robust solutions to filtration problems. A similar, one voice, approach requires to be found for other discussion points. For example, post-sterilization integrity testing causes an elevated risk. Why though are some vendors in denial, because they offer a magic test kit, which will solve all the associated problems, including meeting sales target. For me, just a disturbing sight.
Rather take this approach: http://www.americanpharmaceuticalreview.com/images/article/9_Jornitz.pdf
No comments:
Post a Comment