Services - Testing and Analysis
At The BioProcess Institute we are highly experienced in Performance Testing, Analytical Testing, Prototype Development, and Product Failure Testing. We have performed these testing services on a variety of bioprocessing components including: single-use assemblies, sanitary gaskets, hoses, valves, diaphragms, tubing and filters. Our clients include both manufacturers and end-users. We are also 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 within the marketplace. We want to help you benefit from our applications experience. Please visit our Experience and Examples section for more information on cases we have dealt with.
BIOPROCESS PERFORMANCE REPORTS
How Does BPI Assess Performance?
When your company is selecting a sanitary diaphragm for a particular application, or you want to compare your sanitary gasket to others on the market, what do you do? Do you buy all available components and test them over a period of weeks or months, spending tens of thousands of dollars to evaluate them for service life, cleanability and compliance with industry-accepted performance tests (e.g., BPE Appendix J)? Why waste valuable time and money when The BioProcess Institute (BPI) has already done the work for you and published them in their brand new annual BIOPROCESS PERFORMANCE REPORTS.
In all BIOPROCESS PERFORMANCE REPORTS, performance is assessed in accordance with industry standards. Acceptance criteria include meeting requirements for pressure, dimensional tolerances, and cleanability. New BIOPROCESS PERFORMANCE REPORTS will be produced annually to ensure they stay industry-current.
What Does the BPPR Consist of?
BPI will produce seven (7) Performance Test reports annually:
- EPDM Gaskets
- PTFE Gaskets
- Silicone Gaskets
- PTFE Diaphragms on ITTÂ® valves
- EPDM Diaphragms on ITTÂ® valves
- PTFE Diaphragms on GemÃ¼â„¢ valves
- EPDM Diaphragms on GemÃ¼â„¢ valves
Standard Performance Tests will consider:
- current market products
- multiple sizes
- multiple configurations
$9999 per BIOPROCESS PERFORMANCE REPORT.Â
For the end-user, BIOPROCESS PERFORMANCE REPORTS also provides an opportunity to review their previously-in-service components (gaskets and/or diaphragms) for service-life comparisons and evaluations relative to BPIâ€™s exclusive database.Â
Using trade-secreted testing methods, The BioProcess Institute has tested and evaluated thousands of gaskets and diaphragms across a multitude of criteria using various configurations. BPI offers this service and many others as they strive to be your expert navigators for the complex world of bioprocessing.Â
PERFORMANCE TESTING SERVICES
The BioProcess Institute provides a portfolio of standard and customized performance testing services including fitness-for-use, proof-of-concept and failure mode effects analysis (FMEA) for single-use and multi-use manufacturing components. We have the capacity to test under simulated bioprocess conditions which will help answer important questions about your componentâ€™s lifecycle and robustness. These custom-designed tests are performed on manual or automated hydraulic and pneumatic systems. The Institute's clients use the data we collect for many applications including demonstration of design, robust performance testing, predictive maintenance, process development, optimization, and product development, change control and nonconformance/deviation support.
The BioProcess Institute's technicians use high precision instrumentation such as: Coordinate Measuring Machines, Video Boroscopes and Scanning Electron Microscopy to evaluate the results of the processes. Â Our facilityâ€™s flexible design features custom computer controlled process systems, which are configured and programmed to The BioProcess Institute's clients' specific needs. These custom designed systems utilize The BioProcess Institute's high quality support systems such as: Automated Process Systems, Steam-In-Place Systems, Autoclave, Clean-In-Place Systems, Clean/Pure Steam, Deionized Water, Glass Washers, Biological Safety Cabinet, Environmental Chambers Served From Qualified Utilities, and Clean Compressed Air.
Available Performance Testing Services include:
BPIâ€™s performance testing services are very helpful to those clients attempting to create and advance a new bioprocessing product. We will work with you from the earliest stages of concept origin, through model creation and into product implementation. Our application experience provides us with the knowledge and creativity to help you develop a unique and robust creation.
Product Failure Testing
When test articles do not perform as expected, you need to know why.Â Valuable information can be gathered by discovering how and why a product has failed. This evidence will help improve the product and determine its potential uses in the marketplace. If your product fails for us, we will help you determine why and uncover potential for improving it. If your product fails for your customers, they wonâ€™tâ€”and you may not hear from them again. [please click here for product failure photos]
In the process of conducting performance testing services for you, The BioProcess Institute often determines that additional analyses should be performed to characterize the disposition of a sample further.Â In many instances, BPI will recommend that the client consider more in-depth supplemental analyses to determine whether a finding is of concern or not.Â Because our customized performance testing subjects the sample to simulated bioprocess conditions designed to your process specifications at an accelerated pace -- criteria to which you may have never exposed your sample -- we sometimes uncover results that require further analytical study.Â The follow-up analytical services when required, are a win-win for both parties: The BioProcess Institute's third-party assessment becomes a complete 'picture' about the effects of exposure testing; the client's product design engineers learn about the effects of exposure testing on a materials science level and can use the results to retool and address issues in their product's design.Â Â Â
ANALYTICAL TESTING SERVICES
The BioProcess Institute offers Analytical Testing to support characterize your processes and components.Â When more in depth analysis is required, The BioProcess Institute directs an extensive network of specialized laboratories to deliver the proper tests to support the investigation.Â We can expedite your sampling needs with detailed chain of custody practices and summarize the results in decision ready format.Â The BioProcess Institute will help you count, size, fingerprint, and map your samples to understand how bioprocess applications impacts your sample's materials science.Â Â
We will work with you to determine which analysis is the right choice for your challenge.Â Analyses often include, but are not limited to:
- Optical Microscopy is often used as the first step in conducting a failure analysis or materials characterization.Â Â Optical microscopes can provide up to 400X magnification and darkfield/brightfield imaging, which can document part markings and any external damage that might be present.
- Scanning Electron Microscopy (SEM) is an important tool for materials and failure analysis and provides high magnification, high resolution images of samples at magnifications up to 50,000x.Â Energy Dispersive X-ray analysis (EDS or EDX) can be applied in conjunction with SEM analysis and is a technique used to identify the elemental composition of a sample or small area of interest on the sample.Â At left is an example SEM image which represented tubing that was exposed to a 24-hour continuous duty with deionized water.Â It shows how the interior of the tubing was affected by the mechanical shear forces within the pump.Â
- Fourier Transform Infrared Spectroscopy (FTIR) is an analytical technique used to identify mainly organic materials.Â FTIR analysis results in an absorption spectra which provides information about the chemical bonds and molecular structure of a material.Â The FTIR spectrum is equivalent to the "fingerprint" of the material and can be compared with cataloged FTIR spectra to identify the material. A few examples of common materials identified by FTIR are:
- Thermosets (hard plastic)
- Elastomers (rubber)
- Thermoplastics [polyethylene (PE), polyvinyl chloride (PVC) and polystyrene (PS)]
- Food Products
- Synthetic Fibers (acrylic, nylon, polyester, rayon)
- Natural Fibers (cotton, silk, wood)
- Other analysis offered:
- Total Protein Identification
- Individual Protein Identification
- Liquid Solution Trace Element Analysis
- Liquid Solution Particle Analysis
- Surface Analysis
- System Metal Surfaces
- Rouge Traps â€“ trade secreted method to evaluate rouge over time
- Particulate Vision System
- Physical Dimensions
- Optical Microscopic Verification
- Coordinate Measuring Machines
- Physical Measuring Tools
- Microbiological â€“ Traditional USP and ASM Methods
- Optical Microscopic Verification
- USP Methods
- Vision Systems
- USP Methods
- EPA Methods
- Trace Element Analysis
- Steam Quality
- Environmental Monitoring
MARKETING CLAIM SUPPORT
Marketing claims are a crucial part of every competitive industry. Great marketing claims should always be supported by research and evidence.Â But, if that data was produced in-house and not corroborated by a credible, independent source, the superiority of your product in the marketplace will be challenged by your competitors and your customers/end-users. Would you be more impressed to hear Lexus tell you how remarkable their new sedan is, or to hear Consumer Reports Magazine or J.D. Power tell you the same thing?
At The BioProcess Institute, we are impartial, highly credible, and, most importantly, uniquely positioned within the industryâ€™s uppermost organizations to provide our clients with key insights into standards and regulations. Our team members hold sought-after leadership positions within many well-respected industry establishments. These highly trained and experienced experts will work with you to define your product claims and satisfy or surpass industry fitness-for-use guidelines via custom-designed protocols and unrivaled testing procedures.
We routinely perform failure analysis for clients and have a keen awareness of the applications, their conditions, and their impact on components. Our Trade Secreted methods of Process Simulation, as well as Inspection and Measurement, are just a few of the tools and sound principles we use to best serve our clients and their marketing claims.
If you have a superior product, we will work with you to prove it, or to improve it.