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Parylene A Safe, Environmentally Friendly Coating June 18, 2008. Lamar Young 7645 Woodland Drive Indianapolis, IN 46278 lyoung@scscoatings.com. Parylene C: Vapor Deposition Polymerization. C. l. H. C. C. H. 2. 2. C. l. C. l. H. H. 2. 2. C. C. n. H. C. C. H. 2. 2.
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ParyleneA Safe, Environmentally Friendly CoatingJune 18, 2008 Lamar Young 7645 Woodland Drive Indianapolis, IN 46278 lyoung@scscoatings.com
Parylene C: Vapor Deposition Polymerization C l H C C H 2 2 C l C l H H 2 2 C C n H C C H 2 2 Chemical formula: C8H7Cl (repeat unit) Molecular weight: 138.60 Elemental analysis:: C, 69.33%; H, 5.09%; Cl, 25.58%
Parylene – A Safe, Environmentally Friendly Coating Problem • Recent proposed restrictions on Halogenated compounds have created concerns for Parylene. Parylenes are getting included with ‘hazardous’ substances. • The Parylene family includes 4 unique types of Parylene, 3 of which include Halogens. • These 3 make up the vast majority of Parylene films supplied in the world-wide market. • Restrictions on these products would impact all industries; military, aerospace, medical, automotive, semi-conductor, and consumer electronics.
Parylene – A Safe, Environmentally Friendly Coating Problem • The presence of Halogens do not indicate that it is hazardous or harmful. • The excellent performance of these Parylene types is due to the presence of Halogens in its chemical structure. • Halogens may be present in various forms and may not create any environmental or health issues. • For example, Parylene C (containing Chlorine) has been used in many implantable devices and electronics for the past 30 years without any known adverse effects.
Parylene – A Safe, Environmentally Friendly Coating • Parylene C has not shown any toxicity, and is not considered a toxic substance or pollutant. • Pyrolysis of Parylene C, simulating incomplete incineration, did not create any dioxins. • Pyrolysis gives toluene, xylene, chloroform methylene chloride, hydrogen chloride and high molecular weight hydrocarbons. • Parylene C is currently used in implantable devices and has been in service for the past 30 years without any issues. • It is not possible to suggest a replacement to medical industry without any technical evidence that there is an issue, and without a qualified alternative. So far, there is no alternative available. • Parylene C is a biocompatible coating and we maintain both drug and device master files with FDA. It has successfully passed biological evaluations (per FDA/ISO standards). • USP tested and certified as a Class VI Plastic (acute systemic toxicity, irritation/intracutaneous reactivity, and implantation).
Parylene – A Safe, Environmentally Friendly Coating • It is almost impossible to replace other existing applications of Parylene C (widely used) in the market. This is primarily due to its specific properties and existing qualification requirements by the customers. Examples: Military, Electronics, Automotive market. • There is no other chlorine free coatings available in the market that can replace the exact properties of Parylene C. • A new material would have to be developed with no guarantee of the similar properties. Research may continue, but no one can assure that an alternative can ever be found. • Over the past thirty years, we have developed more than twenty molecules, but none of them could replace or provide similar properties and processing conditions of Parylene C. • The process emits no environmentally hazardous substances.
Parylene – A Safe, Environmentally Friendly Coating Solution • Do not restrict all materials based on the presence of elemental Halogens. • Identify the individual compounds known of being harmful and list these.
Conclusion Recommendation • We strongly request that the RoHS revision not identify all Halogenated organic compounds as Hazardous Substances.