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Medical Plasticizers & Materials Evolving to Meet the Challenge!Infocards are automatically generated based on industry data. What is an infocard? Substance phthalste may have been claimed confidential, or applkcations not have been provided, and therefore not displayed. More information about the EC Inventory can be found here. Oxandrolone 10mg general european pharmaceuticals dioctyl phthalate dop applications substance was not covered by the EC Inventory, ECHA attributes a list number in the same format, starting with the numbers 6, 7, 8 or 9. The molecular formula identifies each type of element by its chemical symbol and identifies the number of atoms of each element found in one discrete molecule of the substance. The image is dioctyl phthalate dop applications computer—generated visualisation of the InChI character string, which is broadly used as an identifier of chemical structures.
These additives are compounded into certain types of plastics and elastomers to render them more flexible. Embedding themselves between the chains of polymers Spacing them apart increasing the "free volume" Enabling the chains to more readily slip over each other Thus significantly lowering the plastic's glass transition temperature and making it softer Demand for most downstream plasticizer markets is greatly influenced by general economic conditions.
Polyvinyl chloride PVC polymers are one of the most widely plasticized types. Medical device development is indicative of leading edge PVC plasticizer evolution across application segments. Physical properties Ease of fabrication, and Compatibility with intravenous IV solutions and blood PVC products commonly used in medical care, such as IV blood bags and tubing, artificial kidney connective tubing, bubble-type oxygenators, and enema and urinary drainage bags.
These products chiefly contain the plasticizer di 2-ethylhexyl phthalate DEHP , which imparts flexibility to the products. Launched in medical applications in , DEHP is the primary plasticizer in many other medical devices, including: Cardiac catheters Endotracheal tubes, and Certain implanted heart valves and devices Benefits of Plasticized PVC in Medical Applications Initially developed as replacements for natural rubber and glass, medical products made from plasticized PVC are easier to sterilize, transparent, chemically stable and cost-effective.
Plasticized PVC products are convenient to use Their softness and flexibility allow trauma to sensitive tissue and discomfort to the patient to be avoided Furthermore, the collection of whole blood is improved through the prevention clotting and the range of blood treatment options available is broadened Sterilizable, plasticized PVC tubes and catheters do not 'kink' thereby ensuring the uninterrupted flow of fluids critically important whether for the treatment of infants, or open-heat surgery patients Plasticized PVC's transparency also reduces mistakes and allows healthcare workers to see immediately if a fluid is running low or its flow interrupted, while the smooth inner surface prevents blood clots or other disruptions Labels can also be printed directly onto the plasticized PVC surface and cannot be worn off, providing an additional safety feature Medical Plasticizer Challenge Plasticizers serve to increase a polymer's flexibility, elongation or ease of processing workability.
While various plasticizers can be used to soften PVC , the most frequently used are phthalate esters. DEHP also referred to as di-octylphthalate or DOP is a phthalate ester produced from the reaction of 2-ethyl hexanol and phthalic anhydride. Plastics Institute of America Even though the health effects of DEHP have been questioned, it is still the plasticizer of choice for PVC medical and surgical products due to its plasticizing performance and cost.
Insoluble in water, phthalate plasticizers are readily miscible with organic solvents such as plasma and saliva and may result in patient ingestion or absorption during common medical procedures such as blood transfusion, use of tubing for respiration, or in the use of catheters Once absorbed it is believed the plasticizer is stored in the fatty tissue, and can thus be teratogenic able to disturb the growth and development of an embryo or fetus The body's ability to metabolize phthalates once ingested or absorbed is not well understood.
DEHP is suspected to be an endocrine disrupter, affecting reproductive health and being linked to male reproductive tract abnormalities Lately, the risk of phthalates leaching out of the PVC and into individuals has been increasingly debated. While it is still unclear as to what hazards these chemicals pose to humans, research on various other species has shown mixed results. DEHP, the most widely used phthalate, has been associated with a range of adverse effects in laboratory animals including a carcinogenic effect in vivo.
Instead of taking a product-by-product approach, these new laws covering 80, chemicals currently in use, concentrate on the most hazardous, widespread substances first, controlling them at the manufacturing stage, before they leach into the air, water or human skin.
California Assembly Bill AB implemented in early requires the adoption of regulations to establish a process by which materials in products may be identified and prioritized for consideration as being chemicals of concern.
In concert with the Assembly bill, California Senate Bill SB calls for a Toxics Information Clearinghouse to be established for the collection, maintenance, and distribution of specific chemical hazard traits and environmental and toxicological end-point data and is currently underway.
The Medical Devices Directive provisions are adequate to ensure that any material identified as presenting a toxic hazard is replaced as soon as alternatives with a more positive risk-to-benefit balance are available.
As no new evidence indicates that medical devices plasticized with DEHP present an unacceptable health risk to humans, and in view of the proven clinical benefits of PVC medical devices plasticized with DEHP it would be premature to recommend a change to other plasticizers.
Eastman recognized that customers needed options when it came to plasticizer formulation products. DOTP dioctyl terephthalate , a non ortho-phthalate is a para-phthalate; one of the isomeric forms of benzenedicarboxylic acid esters is not adversely listed. It offers good performance properties, excellent low temperature flexibility, resistance to extraction by soapy water and excellent non-migration properties.
In addition, elastic recovery is an important parameter for tubing applications. In the medical device industry, TOTM is used primarily in blood and bag infusion sets. It is inferior to DEHP in terms of cold flexibility. This plasticizer is specifically designed for use in medical articles, especially blood storage bags; however it is not steam sterilizable. Currently used as a plasticizer in medical tubing devices, tolerates steam sterilization better than DEHP. Idealized plasticizer cost comparisons based on numerous industry sources are shown in Table 1 as follows: However, their acceptance across the health care industry is progressing more slowly in part due to the need to develop information concerning the health effects of the alternatives and their metabolites.
Medical Specialty Materials Based in Phthalate Alternatives AlphaGary's 'Superkleen' Specialty Vinyl Compounds AlphaGary's 'Superkleen' specialty vinyl compounds are a new generation of technically advanced specialty materials formulated with an FDA-recognized phthalate alternative plasticizer system. This family of compounds makes use of citrate-based plasticizers, an ATC-IV Alpha additive package based on a derivative of a naturally occurring tribasic monohydroxy acid, which, according to the manufacturer, makes them ideal for molding medical devices, infant toys, and other regulated products.
They are available in hardnesses of 55 to 95A, are functionally equivalent to conventional vinyl, and exhibit similar processing in molding. The advance could lead to a new generation of PVC plastics that are potentially safer than those now used in: Packaging Medical tubing Toys, and Other products The permanent plasticizer effect will also ensure PVC flexibility is maintained with the possibility of extending useful product life.
The functionalized plasticizer DOP-SH [di 2-ethylhexyl 4-mercaptophthalate] was developed with physiochemical properties similar to those of commercial DOP, but with an additional functional group able to establish a covalent bond to the polymeric backbone. The percentage of plasticizer that could be covalently linked to the PVC backbone was similar to plasticizer amounts usually commercially employed.
The approach completely suppressed plasticizer migration. This approach may open new ways to prepare flexible PVC with permanent plasticizer effect and zero migration. PolyOne GLS Thermoplastic Elastomers' Versaflex CL E95 designed for markets requiring a clear, sterilizable, low-extractable material with no phthalates, is a thermoplastic elastomer TPE developed to eliminate the need for plasticizers altogether.
This FDA approved TPE material is stable under gamma and autoclave sterilization, and offers a unique balance of superior clarity, low hardness, and excellent flexibility at low temperatures as compared to competitive products. Target applications include medical tubing, drug storage and delivery, face masks, and infant-care products. Ethyl vinyl acetate EVA Polyolefins PE-polyethylene, PP-polypropylene Polyurethane Silicone, and TPU thermoplastic polyurethane As well as blends and multilayer laminates of these materials A key consideration for these materials is their shelf life in a medical situation - that is their capacity to retain flexible characteristics without leaching harmful chemicals.
Materials used in medical tubing applications must be capable of being formed in a variety of arrangements, have thin inner walls, be durable and strong with low coefficients of friction, and be highly resistant to chemicals and to temperature variations. They must also be weldable to other components of the medical device.
Ethylene vinyl acetate EVA: A copolymer blend used for many years in medical film applications such as for parenteral and enteral solutions and for custom mixing of pharmaceuticals Polyethylene: Stable polymer widely used in medical device applications particularly medical tubing due to its flexibility, transparency and toughness.
However, it is less clear and less flexible than PVC Silicone: A naturally translucent, odorless and tasteless synthetic rubber, it is biologically inert and its inherent lubricity and flexibility eases medical procedures.
Conventional silicone elastomers can have fairly high ultimate elongations, but only low-to-moderate tensile strengths. Consequently, the toughness of most biomedical silicone elastomers is not particularly high Thermoplastic polyurethane TPU: There is an environmental and human health concern associated with the manufacture of TPU, potentially making it less favorable as an alternative from that perspective.
Used as plasticizer for medical devices made with soft PVC products such as tubes for enteral feeding and hemodialysis, bags, respiratory tubes, catheters, gloves and breathing masks www. Studies include alternatives for significant uses of DEHP www. These medical devices have undergone strict regulatory review by numerous government and independent health agencies around the world, including the FDA.
In use for more than 40 years, the safety of these materials has been confirmed through billion patient days of acute exposure and billion patient days of chronic exposure with no indication of adverse effects.
Such alternative materials must also be evaluated on the basis of toxicological evidence and standards of safety typically used and accepted for these applications, and should demonstrate an equivalent degree of safety. Patient safety, functional effectiveness, cost-efficiency, and regulatory compliance will dictate the future selection and preference of medical device materials.
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Established in , Panel members sponsor health, safety and environmental research on phthalate esters. Research, test and promote alternatives to toxic chemicals used in Massachusetts industries and communities.
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the classic application of thermodynamic notions even within the limits of . flow U for PVC on the dioctyl phthalate content. I. 0. % 3c. 7. I. DOP. Fig. 7. Aldrich; Di-n-octyl phthalate >=% (GC); CAS No. Dioctyl phthalate quantities for your development, manufacturing or research applications?. Many translated example sentences containing "dop dioctylphthalat" – English- German dictionary and search engine for English translations.