19 May How to Determine the Correct Resin for Medical Applications
How to Determine the Correct Resin for Medical Applications
As the COVID-19 pandemic continues, the demand for medical products is rapidly increasing across the world. Behind these products are suppliers like PolySource, who work hard to ensure that every product, especially medical products, utilize the correct resins based on the requirements of the application. PolySource can provide a wide range of solutions for the medical market, thanks to a talented team of professionals and a broad portfolio of medical-grade resins. To learn more about PolySource’s response to COVID-19 and how we can help –We Can Help!.
Medical Grade Regulatory Requirements
Before selecting a plastic resin grade based on the functionality of the part, one must first determine the regulatory requirements on the resin to be used, the molder part and the final product assembly. These requirements can include FDA compliance, (even though the FDA does not certify the resin, they set the guidelines that the resins must meet to be called in compliance), USP Class VI, (testing aimed to certify that there are no harmful reactions or long-term bodily effects caused by chemicals that leach out of plastic materials) and ISO standard 10993, (a series of standards for evaluating the biocompatibility of medical devices to manage biological risk). The actual plastic resin can meet these guidelines, or in the case of compounds, all the ingredients in the compound.
The Resin Selection Process
Like any plastic application, regardless of the industry, it is important to understand the functionality of the part. To do this, ask:
- What does the part need to do?
- What is required of the part to perform that function?
- What are the requirements for strength, stiffness, and impact strength?
- Are there any secondary operations on the part that needs to be taken into consideration?
In medical applications, there are additional factors that may lead to added requirements that need to be discovered. For example, asking:
- Will it be a one-time use application or repeated use?
- If it will be used for repeated use, does it need to be sterilized?
- If so, what sterilization technique, (radiation, autoclaving, ETO), will be used and what is required from the resin to meet this sterilization environment?
- If it will be used for repeated use, does it need to be sterilized?
Consider Changing Requirements
One of the new challenges in selecting medical-grade resins is being able to choose a resin that will be able to withstand the new sanitizing techniques and requirements. New sterilizing and sanitizing chemicals and solvents have become more efficient at killing harmful pathogens. However, these chemicals/solvents have become more aggressive toward plastics. With the recent COVID-19 pandemic, medical facilities are now using hydrogen peroxide and bleach in sanitizing, both aggressive chemicals to plastics. In addition, it’s important to understand how the part is assembled, how the unit is cleaned and the resulting exposure it will have with the sanitizing chemicals.
Plastics like polycarbonate and ABS, which have a long history of being used in medical plastics devices, have not responded well with the new sanitizing chemicals. In many cases, processors are finding they have to revert from an amorphous polymer to a more chemically resistant material such as a polyamide, polyester or an aliphatic polyketone. This now requires attention at the beginning of the selection process, to ensure there is an understanding of how the material will be sterilized.
The use of autoclave, polyethylene oxide and gamma sterilization – classic ways to sterile plastics devices, temperatures, and the steam autoclave, has been raised by 10 to 15 degrees Celsius; this puts additional thermal stress on the plastic part.
Consider New Resin Technologies
In late July 2019, PolySource became an official TOPAS® COC distribution partner. This partnership allowed us to diversify our offerings and add additional USP Class VI resins for the medical market. Amid the COVID-19 virus outbreak, having TOPAS as part of our portfolio has introduced us to a large number of new customers who are involved with developing tests and screening methods to detect the virus. TOPAS is an ideal material for use in the analytics plates, which is utilized in high throughput screening. TOPAS molds exceptional well, providing an intricate replication of a tool surface needed for high throughput screening.
When dealing with aggressive cleaning agents, EMS Grilamid TR amorphous nylons should be considered. The results of the medical cleaner exposure study demonstrate the resilient properties of these polymers when exposed to cleaning agents. For almost all the cleaning agents, Grilamid TR polymers outperformed the acrylonitrile butadiene styrene (ABS), polycarbonate (PC), and PC/ABS alloy polymers included in the study.
How PolySource Can Help
At PolySource, TOPAS is just part of our broad assortment of medical-grade resins. Our portfolio ranges from medical-grade polypropylene, ABS and polycarbonate, up to medical-grade polyamides, aliphatic polyketone, PPS and medical-grade LCP. What this means for our customers is our team can replicate what we call our toolbox of resins, or what we use for our existing non-medical customers. Our medical resin portfolio has the same depth that allows us to solve problems, in any temperature range, any type of exposure range and any thermal environment. PolySource offers a complete set of tools in our arsenal to bring a quick, accurate solution to any problem our customers present us with.
Our knowledgeable team is well-equipped to provide technical solutions, no matter what the issue presented to us is. What sets us apart is the depth that we have in our company. PolySource has talented and experienced employees across the US, meaning wherever you are, we have a solution close by.
Discover the PolySource Advantage! Contact our friendly team today.