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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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Parylene a safe environmentally friendly coating june 18 2008 l.jpg

ParyleneA Safe, Environmentally Friendly CoatingJune 18, 2008

Lamar Young

7645 Woodland Drive

Indianapolis, IN 46278

lyoung@scscoatings.com


Parylene c vapor deposition polymerization l.jpg
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%


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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.


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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.


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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).


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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.


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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.


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Conclusion

Recommendation

  • We strongly request that the RoHS revision not identify all Halogenated organic compounds as Hazardous Substances.