The BioProcess Institute is proud to publish BioProcess Performance Reports® (BPPR®) which provide objective foundational data compiled by evaluating and comparing commercially-available bioprocess components after subjecting them to simulated process test conditions.
The first three BioProcess Performance Reports® (on EPDM, PTFE, and Silicone Hygienic Clamp Gaskets) are now available for purchase. In 2016, two more BioProcess Performance Reports®, on diaphragm valves and single-use tubing (for pumps, pinch valves and general use) will be published.
These reports can be used a benchmarks for new components. They are designed to be expandable and tailored to your specific needs while leveraging core information in each existing report. You can use each or any of them as a bridge to assess alternative process parameters.
Our clients have used them to support investigations and change controls as well as to gain perspective on competitors.
Why did BPI create BPPRs®?
As an independent 3rd party testing laboratory, BPI developed BioProcess Performance Reports® in direct response to the industry’s need for component performance data. Everyone wants the data, but the price tag of commissioning customized testing on such a large scale can be very high. BPPRs® contain all the information you need at a fraction of the cost.
Throughout our collective career, BPI engineers and technicians have witnessed numerous examples of process failures where there was little to no information to reference. Whenever there is a failure or a contamination, it seems that the same four components are always at the top of the suspect list: gaskets, diaphragm valves, O-rings, and hoses/tubing. However, we have found that, while failures do occur, seldom are they the direct result of component malfunction, but rather to component misapplication.
The goals of each BPPR® are (1) to provide process application data for the evaluation of component performance; (2) to help determine service life; and (3) to provide a basis for the comparison of different components.
Assessing performance for the BPPR®
In all BioProcess Performance Reports®, performance is assessed in accordance with current industry standards. Acceptance criteria included meeting requirements for pressure, dimensional tolerances, and cleanability.
The purpose of BPPRs®
The main purpose of all of The BioProcess Institute’s BioProcess Performance Reports® is to help you select the best component for your application.
Each BPPR® details the testing and evaluation of the major component brands used in the bioprocess industry. For instance, before testing began for each gasket BPPR®, The BioProcess Institute first consulted with their clients and other end users to determine the most commonly used gaskets. BPI then obtained hundreds of each type of these gaskets, in various sizes, through routine supply chain channels and subjected them to three months of rigorous exposure and performance. Combining their insight, experience, and trade-secreted methods, BPI’s testing procedures mimic common bioprocess conditions. Exposure methods used by BPI during BPPR® testing are, at a minimum, per ASME BPE-2014 Appendix J, but often above and beyond this standard.
During and after the gasket testing, results and observations were scrutinized and evaluated based on the performance by the gaskets in five major categories:
|Sealability||BPI examined nuances and fit-up observing how they changed over hundreds of exposure cycles.|
|Cleanability||BPI studied the ability of the gaskets to maintain their seal at the process interface throughout Steam-in-Place (SIP) and Clean-in-Place (CIP) exposure, using a trade-secreted soiling method.|
|Intrusion/Recess||BPI used techniques and trade-secreted methods, which are unavailable to other testing facilities, to accurately measure and analyze the intrusion and recess exhibited by the gaskets.|
|Observations||BPI interpreted every normal, abnormal, surprising and unremarkable observation. As renowned sticklers, no detail was too small to be recorded and photographed by BPI engineers and technicians.|
|Chemical Exposure||BPI’s exposure methods involved the use of chemicals commonly used in bioprocessing.|
These results, including rankings and justifications, are described in each BioProcess Performance Report®.
What do you get with a BPPR® purchase from BPI?
Each BPPR® includes the results of a pre-study which was conducted prior to testing to determine the initial fit-up and proper tightening torque for each style gasket per size and clamp type. Each BPPR® is comprised of over 150 pages of information and interpretation (presented textually, graphically, and photographically) and organized into seven major sections: Objective, Test Methods, Results, Observations, Discussion, Conclusion, and Recommendations. Purchase of any BPPR® includes ongoing consultation and support from The BioProcess Institute (up to 1 hour per month/12 hours per year from the date of each report.)
Why are BPPRs® important to an end user?
End users have less and less latitude, in their highly-regulated processes, to test alternatives. BPPRs® contain all the test data they need. The BioProcess Institute is an unbiased and independent testing facility. For this reason, end users can employ BioProcess Performance Reports® to validate their service life recommendations, conduct failure investigations, and justify changing to the better-performing gasket. This report can also satisfy change control requirements. In addition, for the end user, BPPR® provides an opportunity to participate in a database of previously-in-service gaskets and/or diaphragms for service-life comparisons and evaluation in order to help verify the results and correlate them to real life experiences.
Why are BPPRs® important to a supplier?
For the supplier, BPPRs® reveal how their component compares to others on the market right now. This detailed assessment comes at a substantially lower cost to the supplier, and within a shorter timeframe, than customized testing. Furthermore, BPI maintains an active dialog with manufacturers and routinely receives feedback from them. They, in turn, use our BPPR®-based findings to determine the applications in which their gaskets are being used and eventually improve these products to meet the needs of their end users.
For more information on BioProcess Performance Report®, including cost, discounts for bundling, and additional customized participation in future reports, please contact us at (401) 294-9000 or firstname.lastname@example.org