Jim’s Blog

Bias in BioProcessing

“It’s not really a question of who is biased, but which bias is the correct bias with which to be biased.” - Jonathan Sarfati   The Stainless People vs. the Polymer People? No, not a dystopian battle. Just a room full of engineers at a recent ASME-BPE meeting defending their biases on multi-use vs. single-use components. Whether male or female, baby boomer or millennial, end-user or supplier, everyone--especially those of us in the bioprocessing standards community--have inherent Continue Reading→

Working Summits on Particulate in Single-Use Systems

We would like to summarize the current state of the industry and to identify areas which should be addressed to improve the overall quality of BioPharmaceuticals. Please click on the flyer for more information.   Continue Reading→

A Bone of Contention

Did you hear about the guy who went in for a hip replacement and the surgeon swapped out all 206 of his bones just to be on the safe side? Me neither, because that would never happen. Right? Then why does it happen every day in the bioprocessing industry? In our industry, a single process can contain hundreds or even thousands of components working in harmony to manufacture a pharmaceutical product. But, although they work together, these components should not be treated as a set. In order to Continue Reading→

Misapplications, Misuse & Misunderstandings

Have you ever tried to assemble a gas grill, a toy on Christmas Eve, or anything from IKEA? If you have, you might understand how that kind of confusion, pressure and frustration can cause component failure in bioprocess lines. Manufacturers do their best to provide users with what they consider to be the proper set of assembly instructions for their product(s).  But, whether those instructions are for a two-story doll house, a trundle bed, or a bioprocess component, at the end of the day, Continue Reading→

Testing on Orphans

Now that I have your attention, let me explain. I have long considered gaskets and diaphragms to be the orphans of the bioprocessing industry. My analogy isn’t perfect, but bear with me. When measured in square inches, they collectively make up a tiny fraction of a process line and are nearly forgotten, but processes cannot function without them. Neglected and underestimated, they try to manage the task of creating perfect seals to prevent contamination and leakage. When something inevitably Continue Reading→