Trichloroethlene and REACH - Any less harmful substitute available?

[mpfizer]

We manufacture medical devices mainly orthopaedic implants , we sometimes use very small amouints of trichloroethylene to clean some implants do we need to register with Reach ?

is there any substitute material avaialable which is not harmful?

what is the harm in using trichloroethylene is it causing harm to the receipent when the implant is inserted in the body or is it harming the person who is cleaning?

is there a need to again wash the implant with some solution after using trichloroethylene? to remove the trichloroethylene?

the weight of the implant is appoximately 800 gms as per the reach defination of 0.1% w/w would we need to register?


could spirit be an alternative ?

michelle

[Dr. L. Ramakrishnan]

I am not an expert on REACH. The following may be useful to you:

1. It depends on what you are cleaning. Substitutes should be available. You need to to know as to what is being cleaned. In many cases trichloroethylene cleaning (vapour degreasing or cold dip) has been replaced by aqueous cleaning and "glycol" cleaning.

2. I doubt if any trace of trichloroethylene will be left behind on your product; but trichloroethylene is a "banned" substance in many MNCs in their operations. Trichloroethylene is a toxic substance which has potential to cause cancer if inhaled in higher quantities than the TLV (TWA) value of 50 ppm during the normal operations.

3. To my knowledge NO. The residual trichloroethylene is supposed to varpourize and leave a dry surface.

4. Even if traces remain, I doubt if that will add to 0.1 % of the mass of the implant.

For more details see MSDS for Trichloroethylene.

One area that those who are using trichloroethylene should be concerned about is the potential soil and water pollution. Tri being heavier than air, will settle down in and around the area of use and contaminate the land and aquefer. The decomposition product of Tri in soil is vinyl chloride, that is a proven carcinogen and one can detect VC in water contaminated with Tri.

With kind regards,

Ramakrishnan

[SteveK]

Hi Michelle,

We used Trichloroethlene to vapour clean the metal components of our medical devices. We have now replaced this with 'Vapour-Kleen' (Absolute Solvents Ltd), which is mainly Methylene Chloride with some Acetone and ionic surfactant.

Steve

[mpfizer]

Hi Steve

Thanks for your reply could u give some further does Methylene Chloride with some Acetone and ionic surfactant. have to be registered with Reach ?

does this combination stick to the surface or does it evaporate ?

any cleaning required after that ?

we need to clean artificial joints

Thanks

michelle

[somashekar]

In Reply to Parent Post by mpfizer

Hi Steve

Thanks for your reply could u give some further does Methylene Chloride with some Acetone and ionic surfactant. have to be registered with Reach ?

does this combination stick to the surface or does it evaporate ?

any cleaning required after that ?

we need to clean artificial joints

Thanks

michelle

For a product as critical as yours like the implant, whatever solvent is used, it is to be ensured that traces of it are not present on the surface. You may resort to some final cleaning process with pure water and / or UHP Nitrogen blow.
Regarding registration part, the attached information may give you some insight...

[Kales Veggie]

In Reply to Parent Post by mpfizer

We manufacture medical devices mainly orthopaedic implants , we sometimes use very small amouints of trichloroethylene to clean some implants do we need to register with Reach ?

is there any substitute material avaialable which is not harmful?

what is the harm in using trichloroethylene is it causing harm to the receipent when the implant is inserted in the body or is it harming the person who is cleaning?

is there a need to again wash the implant with some solution after using trichloroethylene? to remove the trichloroethylene?

the weight of the implant is appoximately 800 gms as per the reach defination of 0.1% w/w would we need to register?


could spirit be an alternative ?

michelle

Only the manufacturer can register the cleaning solvent. As a user, you can not register.

From your description, it appears to be a process chemical and not put on the market as part of the implant.
Are you concerned about the residue?

If you want to find out if this substance is registered:

http://apps.echa.europa.eu/registere...tered-sub.aspx

or preregistered:

http://apps.echa.europa.eu/preregist...tered-sub.aspx

[mpfizer]

yes it is a process chemical , so we need not register ?

any alternatives for this chemical which are safer for use?

[somashekar]

In Reply to Parent Post by mpfizer

yes it is a process chemical , so we need not register ?

any alternatives for this chemical which are safer for use?

Have you tried the pure Iso Propyl Alcohol (IPA) or had a look into cleaning solutions in www.alconox.com