Testing and Analysis

The BioProcess Institute is highly experienced in Performance, Exposure, and Analytical Testing. We do it all day long. Every day. Our keen awareness, trade-secreted methods, and expertise in all areas of bioprocess testing are what give us the competitive advantage. Our niche is customized testing methodology and we want you to benefit from our experience.

We perform these testing services, for end users and manufacturers, on a variety of bioprocessing components including: single-use assemblies, sanitary gaskets, hoses, valves, diaphragms, tubing and filters. Suppliers, we are uniquely equipped to provide you with a well-informed and independent assessment of how your product performs and how its performance and expected endurance compares to others on the market. End users, we want to help you select the correct component or material.

Fray Release Study in Process Hoses

Prototype Gasket Performance Test

Prototype Sterile Valve Performance Test

Diaphragm Prototype Performance Test

Performance & Exposure Testing                                                                              

BioProcess Performance Reports® (BPPR®)
In addition to providing customized, confidential testing and consulting, BPI 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 available for purchase.  Clients have used them to support investigations and change controls as well as to gain perspective on competitors For more information on BioProcess Performance Reports® please CLICK HERE.

Prototype Development
Prototypes are the backbone of bioprocessing’s future. The field cannot grow without constant innovation. BPI helps clients verify and improve, when appropriate, their component prototypes through customized testing followed by thoughtful conclusions and recommendations. We have tested many prototypes over the years using parameters required by our clients and additional ones suggested by us. We will find answers to qualification questions such as: Is it cleanable? Is it able to function in the process? Can it show equivalence? How does it perform compared to similar components already on the market? Based on our testing and analysis, clients have modified their prototypes with either small tweaks or total redesigns. In other cases, they’ve acquired the independent, third party backing they needed to confirm the quality and effectiveness of their products in order to make market claims. Test results can be used by manufacturers to show end users how they can justify component change in their application(s).

Service Life Assessment
Knowing the true service life of a component, manufacturers can accurately market their product and end users can make informed purchasing and replacement decisions. At BPI, assessing the service life of a component is done through testing which simulates typical process conditions using a fully-automated testing system. Our robust data collection, alarming and controls allow us to mimic the conditions to which a component would be exposed, but in an accelerated timeframe. Test data is then analyzed, resulting in conclusions and recommendations for the client. We provide data to support frequency of maintenance and appropriate service life assessment up front or during use. We can assess the life of in-service or failed components.

Component Exposure Analysis Project

Analytical Testing                                                                                           

The BioProcess Institute partners with the best-in-class analytical and biocompatibility service providers.  We provide a network of high-end analytical laboratory and consulting services for a variety of bioprocessing customers – end users and manufacturers alike. Some of our key analytical services include method development, laboratory outsourcing, problem-solving, and compliance testing.

We understand how to manage the analytical process for you because we know how the bioprocessing environment works.  We understand the requirements and are outfitted with the tools and resources to find the answers for you all under one roof!  Some of the typical standards and regulations we use as guidelines include:

  • ASME BPE-2014
  • ISO 10993
  • USP Class VI

Product Failure Analysis
involves studying and determining the failure of materials such as polymers, elastomers, and thermoplastics and assessment of their service life.  A seal which has failed is analyzed using various techniques to identify the cause and mode of failure.  We study thermal and chemical effects and investigate whether mechanical failure, fatigue from stress/strain, contaminants, or poor design are to blame.  We determine the root cause of the failure and then define corrective action to help prevent recurrence of the issue, which will help ensure that the biopharma process is not affected.

Clients are encouraged to send us their previously in-service components so that they can be compared to new ones.

Certificates of Conformance (COCs)
are issued by The BioProcess Institute following Class VI analyses for FDA and ISO compliance. Additionally, BPI issues COCs on commercially-available components with respect to compliance with ASME BPE-2014 acceptance criteria (intrusion/recess category compliance).

ANALYTICAL TESTING AT-A-GLANCE

  • USP <87>, <88> Class VI Biocompatibility
  • ISO 10993 Material Characterization
  • Modified Class VI Protocol that meets both ISO and USP Class VI
  • Certificates of Conformance (COCs)
  • Extractables and Leachables Testing
  • USP<788> Particulate Analysis
  • Scanning Electron Microscopy (SEM)/Energy Dispersive X-Ray (EDS)
  • Auger Electron Microscopy
  • X-Ray Photoelectron Spectroscopy
  • Optical Microscopy
  • TOC
  • FTIR
  • TGA
  • VOC, SVOC, NVOC, ICP-MS Analyses
  • And more…