Plastic Materials for Medical devices
July 2015
Table of Contents
Abstract 1
1. Medical Plastics Market overview 1
2. Polymer materials 2
3. Healthcare Domain requirements 3
3.1 Sterilization compatibility 4
3.2 Biocompatibility 5
3.3 Benefits of Medical Polymer knowledge 6
4. Summary 6
5. How will your use case bring value to IGATE business/vertical 6
6. References 6
7. About the Authors 6
Abstract
Polymers popularly coined as “plastics” have proved their importance in different areas like FMCG, pharma, automobiles, etc. Plastics are versatile materials with unique properties like high strength to weight ratio, good aesthetics; good Processability, balanced engineering properties and optimum cost led its entry into medical
Modern healthcare would be impossible without plastics medical products we tend to take for granted: disposable
Syringes, intravenous blood bags and heart valves, etc. Plastics packaging is particularly suitable for medical applications, thanks to their exceptional barrier properties, light weight, low cost, durability, transparency and compatibility with other materials.
Figure 4: Polymer Families
3. Healthcare domain requirements
Medical devices demands for specific properties in addition to general properties like mechanical & electrical. Sterilization and biocompatibility plays prime role in selection healthcare polymer. Material knowledge and its selection process is the key step in product design and development process. Following are few design requirements enlisted for medical devices design:
Sterilization
Biocompatibility
Good chemical resistance
Colour
Texture
Reusable / Disposable
Duration of contact
Mechanical
Plastics react differently to various sterilization methods. The most common sterilization methods are radiation (gamma/e-beam), chemical (ETO) and autoclave (steam). The majority of thermoplastic polymers can withstand exposure to toxic Ethylene oxide (ETO) without significant changes to their properties or colour during sterilization.
However, plastics subjected to radiation sterilization will be affected, and it may change the mechanical properties of the material such as tensile strength, impact strength and elongation by chain scission or cross-linking. It is also important to note that multiple exposures to radiation are cumulative. In terms of mechanical performance, PC is generally resistant to radiation, but it will discolor with radiation exposure. The key to selection is highly resistant plastics which can perform well after sterilization. Figure 6: sterilization methods
Table 1: Medical polymers resistant for radiation process
# Radiation process Resistant Materials
1 E-beam sterilization Styrenic, Olefins, PC, Acrylics, Blends
2 Gamma sterilization PC, acrylics, sulphides,
STERILIZATION Competent SPD (sterile processing department) technicians must be knowledgeable about all available sterilization methods, regardless of whether those methods are currently being used at their facility. The sterilization equipment, sterilization parameters, and loading and unloading of sterilizers are all critical components of effective sterilization .in addition, sterilization processes must be monitored administratively, biologically, and chemically. It is important that all
There are three risk levels (low, medium and high) associated with sterile compounding. CSPs are assigned a risk level based on the probability of contaminating the preparation during compounding with microbial contaminants e.g. spores or endotoxins and chemical and physical contaminants e.g. skin particles from staff or broken glass. Once a CSP is classified, a licensed healthcare professional overseeing the sterile compounding can then decide upon the most suitable procedure and environmental quality of the facility which are necessary for preparing the CSP. The risk levels apply to the quality of the CSP d...
Alumina and zirconia ceramics have been widely used in orthopaedic hip replacements for the past 30 years. The advantage of using these was lower wear rates than those observed using polymers and metals. Because of the ionic bonds and chemical stability of ceramics, they are relatively biocompatible and therefore more preferable to use than metals and polymers. Alumina is most commonly used as a femoral head component instead of a metal in a hip prosthesis because this would reduce the polyethylene wear that is generated. Alumina is a desirable biomaterial to use in hard tissue implants because of characteristics like excellent wear resistance, high hardness, bio inert, low abrasion rate and good frictional behaviour. Furthermore, it has excellent surface finish as well as high fatigue streng...
Piringer, O., & Baner, A. (2008). Plastic packaging: interactions with good and pharmaceuticals. New York: Wiley-VCH.
such as those that give off radiation as well as x-ray machines, and medical devices. The FDA is
Although companies across the globe continue to produce multiple polycarbonate #7 plastic products with BPA, more is being noticed about the adverse health effects to humans can be harmful. Testing on mice has proven that some exposure to BPA can be linked to Cancer and neurological disorders. In countries which have banned the use of BPA in different products, would agree that this chemical is toxic and dangerous. However, as long countries like the United States, who do not currently support banning BPA countrywide due to limited scientific data to back all claims, BPA will continue to be a global issue which continues to be hidden in the dark and a mystery globally
Polyethylene (PE) is one of the most commonly used polymers which can be identified into two plastic identification codes: 2 for high-density polyethylene (HDPE) and 4 for low density polyethylene (LDPE). Polyethylene is sometimes called polyethene or polythene and is produced by an addition polymerisation reaction. The chemical formula for polyethylene is –(CH2-CH2)n– for both HDPE and LDPE. The formation of the polyethylene chain is created with the monomer ethylene (CH2=CH2).
Since human recognize the material, biomaterials have had initial development. As early as 3500 BC, the ancient Egyptians used sutures made of cotton fiber or horse hair, and in 16th century gold plate was used to repair jaw bone and ceramic materials were used to make dedendum, and so on. With the development of medicine and materials science, especially the success of the research and development of new materials, such as the rapid development of polymer materials in the 1940s provides a great opportunity for the research and application of biomaterials. It could be said that in addition to the brain and most
Polymer-Polyethylene is partially crystalline as well as amorphous because it has crystalline and amorphous regions. Also it has linear chains so this is the simplest structure compared to a branched or network chain. This can be of an advantage to it over other types of materials as its good toughness and elongation makes it very significant in the engineering industry as it can be moulded or extruded into shape...
There are numerous factors which can affect dimensions of subsequent casts on repetitive pouring. These include the process of polymerization (7), temperature (1), and material used to fabricate the replica or working cast (1). Although, PVS impression materials have demonstrated superior dimensional stability when compared with other elastomeric materials due to no releasing any by-products (8), it had been reported that the dimensional accuracy of a material is time dependent. A material may be highly dimensionally accurate soon after its initial polymerization but less accurate after the storage for a period of time (9). On the other hand, PVS impression materials have chosen as the impression material in many clinical situations because they possess excellent physical properties and handling characteristics
In addition, the plastics have shown to generate more damage to the environment in the long-term than any other sources of energy. So, it becomes our responsibility to preserve the environment creating mass awareness. The practice of bio-plastics are an environment friendly method, which doesn’t use the landfills while recycling and deposition, but it is also not that convenient method because the cost of manufacturing bio-plastics are much higher than ordinary method. This directly indicates that the cost of minimizing the waste, the cost of human health and environmental pollution is much higher than the production of
The only way to ensure that sterilization has occurred is to use the biological monitoring methods. This is because these are the only tests done which show whether or not actual microbial life has been killed. Biological methods are the only ones which are recommended by the CDC (Centers for Disease Control and Prevention), the AAMI (Association for the Advancement of Medical Instrumentation), the AMA (American Medical Association), OSHA, and OSAP (Office Safety and Asepsis Procedures Foundation)
It would be difficult to imagine the modern world without unreinforced and reinforced plastics. Today they are an integral part of everyone's life-style, with products varying from commonplace domestic to sophisticated scientific products. In fact, many of the technical wonders we take for granted would be impossible without these versatile and economical materials.
Plastic is used in everything from food containers, to shoe soles, plastic bottles, baby bottles, sippy cups, medical devices, dental sealants, water bottles, specific hard plastics, and reusable water bottles. Additionally, inside these packaged items is a synthetic compound lining that has been used to reinforce these plastics and cans for more than 40 years (Shaw).
that make thousands of types of plastics. Ink pens, car parts and plastic bags are all made