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Ultra high molecular weight polyethylene (UHMWPE) is commonly used as a bearing surface in hip, knee, shoulder, and other total joint replacement arthroplasties. Aging of UHMWPE that has been irradiated without additional treatment to stabilize the residual free radicals can result in oxidation followed by chain scissioning. Researchers will usually measure oxidation index to characterize shelf‐life, but this technique does not capture the actual degradation due to oxidation. In this study, gamma sterilized UHMWPE was accelerated aged, and the molecular weights of extractable material
were characterized with gel permeation chromatography in an attempt to see if this technique can be used to characterize shelf life of the aged material.


The extraction of the polyethylene material in this study shows that there is a molecular weight difference between the unaged and aged material, with the aged material showing broadening in the molecular weight distribution. This change can be explained by oxidative degradation, which is supported by the oxidation index. The test methodology shows that a larger ratio of solvent to sample is required to ensure extraction without gelation of the extracted material, and that 4 hours is sufficient to extract the larger molecular weight species. The impact of the molecular weight change on in vivo performance, however, cannot be discerned from this test.


See the poster presented at the Orthopedic Research Society in March, 2015 here.

Chocolate is a complex structure containing consisting of cocoa powder, sugar, fat solids (primarily cocoa butter). The cocoa powder and cocoa butter both come from the cocoa bean following roasting, grinding, and liquification. The flavor and mouth feel of chocolate will depend on the ratios of these components, as well as their size and structure. For the cocoa butter alone, there are six different crystalline structures that it can assume depending on its processing, which will impact how shiny the finished product is, how it melts in your mouth, and if it will undergo blooming, the development of a gray coating on some inferior brands of chocolate.

Cambridge Polymer Group analyzed multiple types of chocolates, looking at their chemistry, morphology, rheology, and mechanical behavior.  Alkaloid content, primarily caffeine and theobromine, was analyzed with chromatographic techniques, along with microstructural information by scanning electron microscopy.

The full application note can be found here.

The pore size in filters, membranes, and fabrics can be determined at Cambridge Polymer Group by a variety of methods, including optical and scanning electron microscopy, mercury porosimetry, and particle size exclusion. A commonly used method is ASTM F316 "Pore size characteristics of membrane filters by bubble point and mean flow pore test." This standard describes two test methods to obtain pore size in filtration media by making use of gas transmission through the filtration media. In both methods, the filtration media (in the form of a sheet) is cut into a disc, which is then placed in a filter holder. One side of the filter holder is connected to a gas line with a pressure regulator. The other side is vented to the atmosphere. In Method A, a fluid of known surface tension is placed on top of the filtration media on the vented side. The gas pressure on the other side of the filtration media is slowly increased, and the experimenter looks for the lowest pressure where gas bubbles begin to rise from the filter, indicating that the gas pressure has overcome the interfacial tension of the liquid in the pores. The maximum pore size can be calculated from this pressure and the surface tension of the fluid. In Method B, the same apparatus is used, but with the addition of a gas flow meter. In this variation, the gas pressure is also slowly increased, and the flow rates of gas through both a wet filter (using the fluid of known surface tension) and a dry filter are recorded.  The percentage of filter flow rate can then be determined as a function of pressure, which in turn is related to the pore size.

Contact CPG for more information on performing this test on your filtration media.

CPG was a sponsor of MIT's 5th annual Polymer Day Symposium, held on March 11, 2015 at MIT. The event is hosted by MIT's Program in Polymers and Soft Matter. A poster session was held in the morning, and two CPG scientists, Svirkin and Kozak, acted as judges, and awarded prizes to the top posters. More information on the Symposium can be found here.

The success of a medical device depends on both the details of its design and the proper selection of materials from which it is fabricated, taking in to account its final use and regulatory requirements. Success also depends on how it is manufactured, and a critical feature of medical device manufacturing is ensuring a suitably clean product. Cleaning is almost always performed in the final stages of manufacturing, but some manufacturing processes may include intermediate cleaning steps.

To ensure that the cleaning process is doing its job, manufacturers will perform cleanliness measurements on their devices to determine how much manufacturing residue remains on the part, and the nature of that manufacturing residue. Simply quantifying the presence of residues is not sufficient however, because this does not account for how sensitive the design is to that residue.  For example, residual sodium chloride may be acceptable at gram quantities, whereas arsenic may not be acceptable at any level. A critical step in clean-line validation that is often missed is therefore to assess what is an allowable amount of residue while still ensuring a good clinical outcome of the device.  Often this involves are considered cost-benefit analysis between the effort to clean, and the risk associated with that residue.

Cleanliness measurements are either performed by removing the residue from the part and quantifying the residue with various analytical assays, or by measuring the residue in situ on the part. The latter technique is less suitable for quantification measurements, but is useful for identifying where on the part the residue is residing, which may assist in modifying either the cleaning process or the part design. Cleanliness measurements include residue weighing, FTIR, GC and LC/MS, ICP, UV-Vis, and SEM-EDS to quantify and identify sources of residue.

To assess what levels of residues may remain on the part without impacting the clinical performance, manufacturers often look at devices on the market already in the same application area with good clinical history, and measure their residue levels. These levels can serve as guidance for establishing acceptable manufacturing residues. Alternatively, toxicological studies can be carried out, or  some animal studies.

The manufacturers clean-line can then be validated using the cleaning assays discussed above, along with the allowable residue levels the manufacturer previously determined. To validate a clean-line, a representative number of devices are tested under normal operating conditions as well as the extremes of the operating conditions, to see if the process is in control.

ASTM offers several standards for testing the cleanliness of medical devices, and new standards are being developed for clean-line validation and establishing allowable residue levels. Cambridge Polymer Group performs these standards for clients, and assists with clean-line validation.


Case studies on medical device cleanliness can be found here.