Cambridge Polymer Group is an ISO 9001 certified, ISO 17025 accredited, and DEA-licensed laboratory located in Boston. We can provide basic and applied research and development throughout the lifecycle of your project or concept. With our diverse range of skills including biomedical, chemical, mechanical and electrical engineers, as well as physics and of course chemistry, we can take your paper napkin concept through initial concept, all the way to assist you with regulatory filings and manufacturing scale-up. Our diverse experience across medical, pharmaceutical as well as consumer and industrial products gives us unique insight into your product and design, and our internal R&D allows us to provide a unique one-stop service in product and material development. We offer: * Routine analytical testing * Custom test design * Medical device testing * Device development * Outsourced R&D * Hydrogel tissue models * Cleaning validation * Polymer selection * Leachables and Extractables We have specific expertise in polymer science, and can help you select the appropriate polymer for your application, develop new formulations, or deformulate existing materials.
CPG develops custom hydrogel formulations to mimic properties of native tissue, such as fat, muscle, skin, and fascia. The properties include mechanical behavior, lubricity, puncture resistance, elasticity, electrical properties, ultrasound appearance, and appearance. We can prepare custom geometries based on client needs. The models or phantoms can be used for testing medical devices or surgical tools, or training medical practitioners.
Expertise in shear and extensional rheometry of polymer solutions and melts. Testing services include small amplitude oscillatory, steady shear, yield stress analysis, extensional breakup, and cure behavior of materials.
CPG acts as an outsourced R&D laboratory for medical device development. Our multi-disciplinary staff can provide you with the cross-technology experience that is vital to develop your core technology into a viable medical device concept or instrumentation solution. We work with your team to develop initial concepts, reduce them to proof-of-concept devices, and then assist in transfer to manufacturing OEMs. We also provide testing in support of regulatory submission.
CPG has over 20 years of experience in polymer characterization, in materials ranging from polyethylene, silicones, PEEK, acrylates, polyurethanes, polyimides, polysulfones, elastomers, and hydrogels. We can characterize properties including mechanical, chemical, thermal, shelf-life, chemical resistance, and wear. We specialize in custom test design, and can also test to many ASTM and ISO standards.
CPG provides liquid chromatography with mass spectroscopy analysis of elutable materials from devices, composition analysis of liquid and pharmaceutical formulations, and deformulation analysis of unknown compounds.
CPG performs extractables and leachable studies for product development, quality control, and regulatory approval for pharmaceuticals, medical devices, food products, cosmetics, and packaging.
LEACHING AND EXTRACTION CONDITIONS
Scientists at CPG design simulated conditions to mimic the relevant environment for the product in question.
These conditions may be:
For extraction studies, the relevant solvent for extraction is selected based on the leachable component in question, along with extraction conditions (temperature and duration).
The analysis technique to identify and quantify the leaching or extraction behavior is selected based on the leachable compounds in question, but usually include one or more of the following:
Analysis is often performed in time studies, to determine the elution rate as a function of exposure time.
Coatings, coating flow and coating adhesion involve multiple phenomena that often result in complex processes and complicated behaviors. Shear and extensional rheology can be equally important in the actual coating process, but often mass-transfer for solvents and heat and cooling rates also play a part, as well as the surface chemistry and how the surface interacts with the coating. In addition, coating molecularly thin layers involves understanding the surface chemistry and tools required to create robust layers and activations. The balance between all of these phenomena, and the manner in which they evolve, will strongly influence your outcomes. Although often one might consider coating flows as being large-scale industrial applications and printing and web coating, these processes play a significant role in less obvious applications. For example, drug-eluting stents can be coated using a roll-method, and thin films can be made in this manner. By leveraging CPG's broad expertise to gain a complete understanding of a procedure's physics and sensitivity to conditional variations, our clients are able to maximize the potential utility of new materials and products. In addition, changing the surface chemistry of your material can greatly enhance adhesion or functionality, and through our partner at PlasmaTreat (www.plasmatreat.com) we can provide the concept-to-production service you require to maximize your product's performance.
Qualitative and quantitative liquid injection GC-MS, GC-FID, and head space GC-MS. Expertise in trace solvents, degradation products, composition identification, and unknowns analysis. Typical turnaround time 10-15 days, with rush options. Reports include detailed analysis of chromatograms and compound identity, instrumentation information and calibration records.
CPG has expertise in dynamic mechanical characterization of materials. Tests can be run in frequency or temperature sweeps, or static tests monitoring creep or stress relaxation behavior.
CPG personnel head up the ASTM task group on medical device cleanliness. We provides testing services to assess how clean your medical devices are, and assist in cleanline validation. We can also assist in risk analysis based on identified compounds.
To determine the true performance of a material over time requires shelf-aging and follow-up testing. In reality this is time consuming and costly to perform and so often accelerated aging protocols are used to accelerate the process. Generally speaking these make use of the Arrhenius equation to map an elevated temperature to an effective ambient age through an assumption that all chemical reaction rates are accelerated equally. Although care must be taken in making this assumption (phase transitions and thermal activations must be considered) these tools are routinely used in orthopaedics (ASTM F1980 and F2003) as well as in other industrial applications (ASTM D5427, D6521, D3434 and others). In addition, modifications to these tests for specific conditions are often necessary, such as increased pressures or temperatures, specific gases, or environments that mimic in vivo conditions. We can run the aging tests, and then analyze the samples for changes in chemistry, mechanical properties, or degradation product development.
Multiple detectors, include MS, UV, ELSD, QTOF.
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