Lamar Parylene C- For Brussels Meeting 6-18-08 RevA

8/2/2019 Lamar Parylene C- For Brussels Meeting 6-18-08 RevA

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ParyleneA Safe, Environmentally Friendly Coating

June 18, 2008

Lamar Young7645 Woodland Drive

Indianapolis, IN 46278

[email protected]


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Parylene C: Vapor Deposition Polymerization

H2C

H2C

C H2

C H2

C l

C lH2C

H2C

n

C l

Chemical formula: C8H7Cl

(repeat unit)

Molecular weight: 138.60

Elemental analysis:: C, 69.33%;

H, 5.09%; Cl, 25.58%


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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


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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 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 devicemaster files with FDA. It has successfully passed biological evaluations (perFDA/ISO standards).

USP tested and certified as a Class VI Plastic (acute systemic toxicity,irritation/intracutaneous reactivity, and implantation).



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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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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.

Documents

Lamar Parylene C- For Brussels Meeting 6-18-08 RevA