Pre-use/Post-sterilization integrity testing - the use of a debate for commercial purposes !

Why, one has to ask, is it that a scientific, biopharmaceutical industry topics ends up to become ones again a commercial opportunity to some ?!
Is it not bad enough for the industry to convince regulators that a) processes and activities used for decades in the industry work reliably and b) one knows what one does, i.e. leave the decisions to the end-user ? No, instead of supporting the industry with expertise and a one voice approach, scientific and/or regulatory topics become a contest by the supply industry ! The "who knows best" game is played and unscientific debates spur the fire of confusion. Moreover in instances like this, the regulatory confusion is even used as a commercialization opportunity. Purely to gain a few percentage points of increased revenue an entire industry is subjected to non-common sense regulatory demands.
When do suppliers realize that not the supplier with the highest commercial sense, but the one with the most scientific sense and support will be embraced by an industry which is scrutinized enough ?
A prime example is the current debate of the necessity of pre-use/post-sterilization integrity testing. The topic is fairly easy to resolve; leave the decision whether or not such integrity test should be performed or not to the end-user, to the industry. They perform the riosk assessment and not the supplier, they require to justify their activities to regulators and not the supplier and they have the best experience with their processes and not the supplier. The supplier should support with data, when asked for and required. This topic is not about the ability to perform such test and the great engineering abilities of suppliers, it is about the choice of the industry to either perform such test or not and what are the risks involved.
However, as usual, some suppliers think to take advantage out of a situation like this, express their unsolicited opinion and cause more problem for the industry than good.
Time to stop this nonsense and rather put science in front of commerical motivations !

Are sterilizing grade filters commodities ?

Sterilizing grade filters are once in awhile perceived a commodity item, especially by procurement departments, not realizing that this is far from truth. Technical departments choosing the right or better optimal sterilizing grade filter for a specific application understand the importance of the utilization of the optimal filter. If the filter is is chosen by pricing instead of performance, the actual costs is far higher than the savings of the price of a filter. Filter performance is not only measured by its retentivity, which is a required must anyway, but also by proper sizing, unspecific adsorption, premature fouling, thermal and mechanical stability etc. If he filter system is improperly sized, the hold-up volume will result in major product losses. Tests in unspecific adsorption showed potential losses of hundreds of thousands of dollars of product on the membrane surface. Sterilizing grade filters testing is of importance to find the optimally balanced filter for the specific application, then the procurement department can negotiate pricing, but should fully understand that the optimally balanced filter will safe far more money than a 20% discount.