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Pest Control - FDA approved list of Pesticides to use for Pest Pontrol in a Cleanroom

C

csterling

#1
Hi to all;

I would appreciate all the help with the following:

1- Is there any FDA approved list of pesticides to use for pest control in a cleanroom or in the medical device industry in general?

2- what considerations must be taking when deciding to use a pesticide for pest control.

PS: we are a medical device contract manufacturer.

Thanks in advanced for all the help.
 

arios

Your Mexican Amigo
#2
Re: Pest Control - FDA approved list of pesticides to use for pest control in a clean

I have been told about the following essential practices about Pest control in the MD sector:

1. Use of EPA approved varieties of pesticides. Make sure the contract with the Pest Control service supplier indicates so

2. It is expected to have a program for the application of pesticides, but not into the controlled environment area. Have records to show evidence, I would keep thm with a retention time equivalent to PM records.

3. Evidence of insects or rodents inside could mean an ineffective program.

4. Don't have into the clean room those types of bug zappers that electrocute insects. They kill the bugs but can spread around pieces of the insect (e.g. legs, heads, poped eyes, little bellies, etc). :nono:

Hope this helps
 

Ajit Basrur

Staff member
Admin
#3
Re: Pest Control - FDA approved list of pesticides to use for pest control in a clean

Hi to all;

I would appreciate all the help with the following:

1- Is there any FDA approved list of pesticides to use for pest control in a cleanroom or in the medical device industry in general?

2- what considerations must be taking when deciding to use a pesticide for pest control.

PS: we are a medical device contract manufacturer.

Thanks in advanced for all the help.

My friend, Alberto has given great advise. There is no such FDA approved pesticides. You may want to check with local environmental regulations also on the pesticides, as some countries do not allow certain chemical agents. The current trend in many countries is to use "bio" agents :)

Some additional info on pesticides are -

FDA - Subchapter 5.8 - Pesticides

EPA Info on Pesticides
 
M

MIREGMGR

#4
Re: Pest Control - FDA approved list of pesticides to use for pest control in a clean

ISO 14644 defines what "cleanroom" means.

A "cleanroom" with pests present isn't a cleanroom.

A cleanroom must be designed mechanically so that pests cannot enter.

As to pesticides...I too have never heard of FDA approval for use of pesticides in the same environment where clean medical devices are processed.

A search of the entire FDA CDRH website for documents containing both the word "pesticide" and the word "cleanroom" finds no matches.
 

Ajit Basrur

Staff member
Admin
#5
Re: Pest Control - FDA approved list of pesticides to use for pest control in a clean

Oh my :bonk::frust:

I did not :read: properly - missed that you wanted for Clean Room.

It is not recommended to use pesticides inside the facility and for Clean Room, its not at all allowed.
 
P

Panik66

#6
Re: Pest Control - FDA approved list of pesticides to use for pest control in a clean

What about for the areas outside the clean room? Or even outside the building? What about an adjoining warehouse?

What regulates what pesticides can be used in these areas for Medical Device Manufactures?
 

Ajit Basrur

Staff member
Admin
#7
Re: Pest Control - FDA approved list of pesticides to use for pest control in a clean

What about for the areas outside the clean room? Or even outside the building? What about an adjoining warehouse?

What regulates what pesticides can be used in these areas for Medical Device Manufactures?
Welcome to the Cove :bigwave:

You could use any pesticides that you feel efficient for your pest management in outside of the clean rooms but not within.
 
M

MIREGMGR

#8
Re: Pest Control - FDA approved list of pesticides to use for pest control in a clean

If you were doing contract manufacturing for my company and we found you had used a pesticide in proximity to incoming, in-process or outgoing materials/products, I'd need to see proof that zero pesticide had migrated to the product at mutagen sensitivity levels (parts per billion) and/or proof that the pesticide is fully ISO 10993 biocompatible.

The latter is highly unlikely for typical natural and synthetic pesticides such as organophosphates and carbamates, which as classes are mutagens, carcinogens and reproductive- and neuro-toxins.

There's no way we would continue to work with a supplier that created a situation in which our products would expose patients to skin contact with detectable levels (again, PPB) of known mutagens etc.
 
J

jamesclarke160

#9
Re: Pest Control - FDA approved list of pesticides to use for pest control in a clean

If you were doing contract manufacturing for my company and we found you had used a pesticide in proximity to incoming, in-process or outgoing materials/products, I'd need to see proof that zero pesticide had migrated to the product at mutagen sensitivity levels (parts per billion) and/or proof that the pesticide is fully ISO 10993 biocompatible.

The latter is highly unlikely for typical natural and synthetic pesticides such as organophosphates and carbamates, which as classes are mutagens, carcinogens and reproductive- and neuro-toxins.

There's no way we would continue to work with a supplier that created a situation in which our products would expose patients to skin contact with detectable levels (again, PPB) of known mutagens etc.
I have never thought of using pesticides in controlling pests. They are effective but harmful. If you know natural pesticides than it would be of great help. Don't mind in posting old thread as it still can be used for gaining pest control knowledge.
 
#10
Re: Pest Control - FDA approved list of pesticides to use for pest control in a clean



Welcome to the Cove :bigwave:

You could use any pesticides that you feel efficient for your pest management in outside of the clean rooms but not within.
Good afternoon and hope you are doing great.
I know that this post was posted long time ago... but right know I have the same question. What is the list of pesticides approved to be use in medical device manufacturing plant? I know that I can't use any pesticide inside of the clean room ... but what about outside?
I am really new in this industry that's why I don't know many thinks... but last week I had an audit and was questioned my approved list of pesticides.
If I can use any pesticide outside... Do you know where I can find information about that?
Thank you so much for your help.
 
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