Material selection plays an important role in the design of a medical device or bioprocessing system. It can improve end-user satisfaction, product reliability, and manufacturability of the device, as well as simplify the 510(k) application process. Various certifications such as animal-derivative-free, USP Class VI, and ISO 10993-5 are just a few of those desired by medical device manufacturers and biopharmaceutical companies. As a result, Value Plastics, a Nordson company, has chosen to mold a large variety of its connectors with a new polypropylene resin in order to better fulfill customer needs and expectations. This material, manufactured by Flint Hills Resources, is represented by part numbers ending in “-6005.” This technical brief will explain the multiple benefits to manufacturers who incorporate this resin into their end products.
Simplified Qualification Processes
USP Class VI and ISO 10993-5 biocompatibility compliance certifications have grown to be common requirements for most Class I, II, or III medical devices and virtually all biopharmaceutical applications. Testing is required for any device coming in contact with tissue or passing fluids that may at any point enter the body. Obtaining the appropriate biocompatibility certification with regard to system components can vastly reduce the amount of testing and paperwork the designer will be required to complete, easing the 510(k) application process. Not only do -6005 components comply with both of these certifications, but the documentation is also easily accessible on Value Plastics’ Web site.
Polymer manufacturers regularly include tallow or similar animal-derived sources in resins to aid in lubrication and processability during the molding process. However, use of these resins presents a certain risk affiliated with Bovine Spongiform Encephalopathy (BSE), belonging to the family of Transmissible Spongiform Encephalopathy (TSE) diseases and commonly known as mad cow disease. Because BSE/TSE is caused by a prion (an infectious protein), transmission mechanisms are not well understood — hence the preemptive shift to animal-derivative-free (ADF) materials. ADF resin is void of any compounds derived from animal sources, essentially eliminating the risk of BSE/TSE and therefore easing qualification work. Many designers now specify ADF material into their products if there is any potential for human tissue contact or exposure to biopharmaceuticals in their applications.
Heightened System Integrity
The polypropylene resin used in -6005 fittings is a random copolymer. This improves processability and offers some other favorable molded part characteristics, including clarity. The increased transparency allows both the designer and end user visibility of the activity inside the connectors and provides reassurance that everything is working properly inside the fitting and that the fluid is flowing freely. For instance, bioprocess systems often require media visibility to help ensure that there are no obstructions impeding proper flow or excessive bubbles within the system, indicating a potential compromise in the system’s integrity.
End-User Safety and Regulatory Compliance
Substances such as latex, Bisphenol-A (BPA), and phthalates present a different set of risks when existent in fluid connectors used in healthcare applications. Latex-free material is highly desirable in order to avoid potential allergic reactions from direct contact. Designers are also choosing to avoid Bisphenol-A (BPA) in plastics due to potential health risks that can surface from the substance leaching into media and being consumed or absorbed by the body. Medical devices have long used materials containing phthalates such as DEHP, a plasticizer used in resins like PVC. Yet in 2002, the FDA issued a Public Health Notification recommending that manufacturers consider an alternative material to avoid the potential harm from phthalates leaching from plastics and entering the patient. Making tubing connectors out of resin that is free of these substances helps to prevent many of the undue problems that may present themselves in various healthcare applications.
Under CFR 314.420(c) and Part VII.A of the Holder Obligations of the Drug Master Files (DMF), holders are required to keep a list of all parties authorized to reference information in the DMF and update the list annually. Holders are required to notify each party affected by any additions, changes, or deletions. Customers are therefore ensured that they will be notified when the -6005 resin manufacturer (a DMF holder) makes any changes in formulation or processing of the material once Value Plastics is made aware of the modification. This guarantees that if any new testing and qualification is required, all customers are appropriately informed to ensure proper compliance and end user safety.
Material Integrity Post-Sterilization
Many healthcare OEMs prefer to incorporate the familiar properties and benefits of polypropylene in their systems, but require gamma radiation as a sterilization method. The resin used in -6005 connectors is ethylene oxide (EtO) and gamma compatible in order to allow flexibility in processes and ensure material integrity through the radiation process — minimizing any potential for issues from material degradation that is common to polypropylenes.
Designers and manufacturers within the medical device and biopharmaceutical industries are not only now required to comply with a multitude of stringent regulations and certifications, but also cannot ignore material features such as transparency and post-sterilization in teg - rity. For these reasons, many companies specifying -6005 fittings into their designs have realized the benefits of the material’s availability.
It should also be noted that to encourage best practices in determining appropriate compatibility with individual applications, Value Plastics strongly recommends sampling connectors for fit and function prior to incorporating them into designs.
This technology was done by Value Plastics, a Nordson Company, Fort Collins, CO. For more information, visit http://www.info.hotims.com/34460-192.