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Join Cambridge Polymer Group scientists Adam Kozak and Stephen Spiegelberg for a webinar on how to establish and mitigate the risks of degradable products in medical devices.

This webinar will focus on techniques to identify and quantify degradation products in in vitro and in vivo environments. Knowledge of the kinetics of degradation products and the degradation pathway will allow researchers to validate simulated in vivo environments and to establish risk profiles for degradable products based on biocompatibility concerns. The techniques are applicable to materials for permanent implants and to biodegradable materials.

This webinar is targeted towards:

• Biomedical engineers
• Medical product designers
• Material engineers
• Regulatory personnel

Duration: 30 minutes

Degradable Products in Medical Devices Webinar 

Thursday, December 8, 2 p.m., Eastern Standard Time

To register, click here.

With the upcoming ASTM workshop on reprocessing of re-usable devices, we thought a primer on this important area of the health care industry would be in order. Reprocessing is a set of procedures that will take a previously used medical device and return it to a state fit for a subsequent clinical use. Usually, the most important steps in reprocessing include (1) cleaning; and (2) disinfection or sterilization.  

Cleaning

The cleaning step should remove biological soils, such as blood and tissue, as well as any other materials that may have contacted the medical device, such as hospital disinfectants, lubricants.

Disinfection

The disinfection or sterilization step is a completely separate step from cleaning, and neither can be substituted for the other. The choice of disinfection (the killing of some or most microorganisms, with the exception of bacterial spores, depending on the level of disinfection) or sterilization (killing all microorganisms to a log reduction, typically 1E-6) depends on the application area where the medical device is used.

Re-usable Medical Devices

A re-usable medical device is one that is intended to be used on multiple patients with reprocessing between each patient. Examples of reusable devices include forceps, stethoscopes, endoscopes, scissors, arthroscopic shavers, and suction tubes. Reprocessing is often conducted either at hospitals or by third body reprocessors. It is up the reprocessor to demonstrate a validated reprocessing procedure for each medical device, which involves demonstration of adequate cleaning through verification tests. The original equipment manufacturer should ensure that the device is designed and constructed to allow reprocessing, and provide adequate instructions on how to reprocess the device, along with appropriate labeling. Proper selection of materials that can undergo repeated reprocessing is an important consideration as well.

The FDA issued a guideline on reprocessing of re-usable medical devices in 2015. 

CPG TRANSITIONS FROM ISO 9001:2008 TO THE UPDATED ISO 9001:2015 STANDARD

Cambridge Polymer Group is pleased to announce that it is now certified as an ISO 9001:2015 compliant organization by International Certifications Ltd. 

CPG is certified as meeting the requirements of ISO 9001:2015 for the following activities:

• Contract Research and Analytical Testing Laboratory
• Design and Manufacture of Custom Materials and Instrumentation

Previous to transitioning to the ISO 9001:2015 standard this November, CPG has maintained ISO 9001:2008 certification since 2010.

ISO 9001:2008 vs. ISO 9001:2015

In September 2015, the International Organization for Standardization released a new revision of the ISO 9001 standard, giving ISO 9001:2008 certified organizations three years to transition. 

In addition to the rigorous quality requirements of ISO 9001:2008, ISO 9001:2015 stipulates that certified organizations assess risk, not only to themselves but also to customers and stakeholders. The updated standard ensures that ISO 9001:2015 certified organizations pay greater attention to the external perspective of customers. 

Cambridge Polymer Group's Commitment to Quality

CPG's early attainment of ISO 9001:2015 demonstrates our commitment to our customers and to quality. We strive to understand our customers' needs and to meet and exceed expectations. Our quality policy is an integral part of our strategy of being recognized as the premier contract research organization in North America, offering a full range of contract research services, excellent technical support and innovative products.

Originally, “Jack o’lantern” meant “man with a lantern,” but was later used to describe the lights that floated over bogs, swamps and marshes. Before science provided possible explanations for these lights, many believed the illuminations to be wandering spirits. Irish children carved lanterns out of turnips and carried them about, simulating the floating lights to scare friends and neighbors.

When the Irish immigrated to North America, they found pumpkins ideal for vegetable lanterns. With its hard, smooth outside rind, the orange Curcurbita was perfect for sculpting scary designs. Carving jack o'lanterns became a popular American Halloween tradition.

Chemical Reactions of Swamp Gases

What was the real cause of the ghost lights? When Italian physicist Alessandro Volta discovered methane in 1776, he posited that the swamp gas interacting with natural electricity produced the swamp lights. Although his hypothesis did not receive much support at the time, it is now generally accepted that the lights are produced by the oxidation of phosphine (PH3), diphosphane (P2H4), and methane (CH4). Created by organic decay, these compounds can cause photon emissions. Only small amounts of phosphine and diphosphane mixtures would be needed to ignite the more plentiful methane to create the swamp lights.

An alternative modern explanation for the lights could be cold flames. These are luminescent pre-combustion auras produced when certain compounds are heated to just below ignition point. Cold flames are usually bluish in color and create very little heat. They occur in an assortment of compounds, including hydrocarbons, alcohols, aldehydes, oils, acids, and waxes. Whether cold flames occur naturally is not known, though many of the compounds which produce cold flames are the byproducts of organic decay.

Other modern hypotheses for the ghost lights include the bio-luminescence of fungus and insects, and the geologic phenomenon of piezoelectricity created under tectonic strain. 

Happy Halloween

At CPG, we pumped our pumpkin full of liquid nitrogen, which we usually use for DMA, TGA, FTIR, and LC-MS. Because we're not just great at solving your polymer problems, we also know how to have some Halloween fun.

Flowers usually open to the sun, but scientists at the University of North Carolina at Chapel Hill have engineered a polymer bloom that unfurls over the course of two hours, due to the location, strength and number of its molecular bonds. This feat of hydrogel horticulture isn’t just aesthetically pleasing, it also demonstrates how a material can be programmed to change shape over hours and minutes, without an external trigger.

Covalent vs. Physical Crosslinks

The UNC team based their smart material on a soft polymer with the texture of human cartilage. The majority of bonds are reversible physical crosslinks which are easily broken and give the polymer its flexibility. A small portion of the polymer’s molecular bonds are covalent crosslinks, which enable the material to return to its original shape after being stretched, like a rubber band. The UNC team adjusted the molecular structure of their polymer so the physical crosslinks would act as a brake against shape recovery by the covalent crosslinks, allowing control of the rate of shape change.

Biomedical Applications of Shape-Changing Polymers

The ability of smart materials to change shape and function without an outside trigger has many potential biomedical applications, including slow-release drug delivery and minimally invasive surgical procedures.

CPG works with shape-memory materials as well, incorporating them into medical devices to produce environmentally-responsive devices. Our devices respond to temperature, fluid environment, salinity and pH as appropriate.

Journal reference: Nature Communications, 10.1038/ncomms12919

The New England office of Cambridge Polymer Group is fortunate to see the brilliant color display every fall as the foliage undergoes its autumnal transformation. Our work in polymer chemistry naturally starts us down the path of wondering what is happening to the leaves to cause this color change. 

The colors in leaves come from three principle sources:

Chlorophyll

Chlorophyll is responsible for photosynthesis in leaves, and provides them with their green color.

Anthocyanins

Anthocyanins provide the reddish colors found in fruits such as cherries, strawberries, and cranberries.

Carotenoids

Carotenoids provide the orange, brown, and yellow colors in fruits and vegetables like bananas and corn, as well as egg yolks and flowers.

Chemical composition of leaf color

Chlorophyll is produced during the growth of plants, typically in the spring and summer when there is more daylight, resulting in the lush green appearance we associate with those seasons. When the days start to grow shorter resulting in less light, chlorophyll production slows and eventually stops. The chlorophyll eventually degrades and disappears, along with its green color. The remaining pigment types, anthocyanins and carotenoids, which were there all along but dominated by the green chlorophyll, now emerge.

Species vs. Weather

The amount and type of color will depend on the species of tree or bush, but also depend on the weather leading up the fall. Warm days and cool nights will result in the production of sugars in the leaves during the day, with the cool nights keeping the sugars in place by closing off the veins in the leaves. The sugars aid in production of anthocyanin, or the red colors we clamor to see in late September in the New England area.