Pest Control procedure requirements? Pesticide / Sprays in Production Areas

W

WisdomseekerSC

#1
During a recent supplier audit by one of our customer resulted in a non-conformance against our Pest Control procedure stating the procedures do not include instruction for use or ban of pesticide/sprays in production areas. We use a pest control contractor which inspect our facilities monthly and treat as needed (exterior, restrooms, stairwells....). We don't specifically state in the contract a ban against interior treatment in production or raw material storage areas, although in practice this is not done so we can prevent potential contamination of product from insecticide residues.

Changing procedures around here requires justification...and making procedures more restrictive is even harder :caution:. The auditor used ISO 9001 section 6.3 c) Infrastructure as the reference. Can someone provide a reference to this requirement from a standard or other regulatory source that is more specific? :read:
 
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A

Alexisss

#2
Re: Pest Control procedure requirements???

We are using an ISO9001 certified pest control contractor. He provided the material-safety data sheets (MSDS) for each chemical he intended to use, and we performed our risk assessment with his assistance. The chemicals he uses are not harmful, hence we do not have any risk.

In your case, that you have the production area, may be you may perform such a risk assessment.

Your procedures may include how do you choose the contractor (criteria - easy if iso9001 certified), how does it affect your product (risk assessment - if the chemicals affect), and how about cleaning operations of the production area.

One thing that I think can be tricky is "where do the dead bugs end up"? What happens if an exterminated bug ends up in your device? (I do not know what r u manufacturing... sorry :rolleyes: )

a
 
G

Groo3

#3
Re: Pest Control procedure requirements???

Yes, to further what Alexisss :agree1: said, a lot can depend on what you are manufacturing and what other requirements may apply. Are there food and drug requirements you need to uphold? medical device requirements? customer requirements? other requirements? There could also be local, state or other government requirements you need to uphold?

If you can provide a little more detail (in general) with what you manufacture, you will most likely find someone on the cove who has experience with that industry... and may be able to help with some examples of how they handled it.

For my site, for the cosmetic, automotive and exterior products we manufacture, we require our pest control contractor to provide us with MSDS's for all chemicals they bring onsite. We also perform a risk assessment for all new chemicals that our EHS department will help review before any new chemicals may be used onsite. In addition, we provide some basic training for all our contractors to make them aware of the potential hazards they may face while working at our facility. We also make them aware of any site procedure requirements. For our pest control contractor, we really basically have two main documents that affect them (1) our MSDS procedure requirements and (2) another document we use to identify chemicals that are banned from use in any production areas... The second document is one some of our customers helped us develop for areas with the potential for a chemical to come in contact with our products.
 
W

WisdomseekerSC

#4
Re: Pest Control procedure requirements???

I appreciate your comments...80+% of our products are extruded components for the medical device industry, Class VI plastics. We also have some specialty manufacturing absorbable and nonabsorbable materials for implantables. Although we do not provide sterile components it is still very important that our products are as clean as possible. We do utilize a cleanroom for final inspection and packaging :yes:. I am trying to acquire more knowledge regarding pest control regulations for the medical device industry.

I will be following up with respect to the MSDS's for the pest control chemicals. We are in the mist of expanding operations and seeking ISO 13485 registration now...so alittle overwhelmed at the moment...Covers' advice has be most valuable.:gossip:
 

GStough

Staff member
Super Moderator
#5
Re: Pest Control procedure requirements???

The auditor used ISO 9001 section 6.3 c) Infrastructure as the reference. Can someone provide a reference to this requirement from a standard or other regulatory source that is more specific? :read:
While it is not necessarily more specific, 21 CFR 820.70(e) Contamination control states: "Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality." This leaves it up to the manufacturer to determine how they will control contamination, but doesn't mandate how it is done, just that it is done.

Also consider 21 CFR 820.140 & 150 Handling & Storage, respectively, Handling: "Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling." Storage: "(a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent...contamination..."

Again, the "how" it's done may not be as critical (at least to the FDA) as the fact that it is done.

Hope this helps. :bigwave:
 

Ajit Basrur

Staff member
Admin
#6
Re: Pest Control procedure requirements???

You could also refer 21 CFR Part 110.35

Though for Food industry, the concepts remain the same for devices and drugs :)

I have copied the applicable sections and pasted below -

(2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. All relevant regulations promulgated by other Federal, State, and local government agencies for the application, use, or holding of these products should be followed.

(c)Pest control. No pests shall be allowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials.
 

bio_subbu

Super Moderator
#7
Re: Pest Control procedure requirements???

In addition to Gstough and Ajit’s reply, I would like to update Singapore Medical devices regulation. “GN-01: Guidance on the Application of Good Distribution practice for medical devices” is insisting pest control program especially in medical devices storage & Handling. Refer page 12 of 32, 3.2.3 Pest control.

Regards
S. Subramaniam
 

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C

csterling

#8
Re: Pest Control procedure requirements???

Hello
Do you happen to have a list of pesticides, insecticides that you could share?

Thanks in advanced.
 
R

RadMedDev - 2010

#9
The only chemicals entering a "clean room" should be those listed in SOP's or BOM's approved for production/manufacturing purposes. Anything else, by default, has not been evaulated with respect to your process/product. If there is evidence of insects in the clean room, then the physical barriers (walls, ceilings, joints, filters, etc), positive air pressure and chemical boundaries at the doors/pass throughs or component unpackaging and pre-cleaning aren't being effective.

MSDS sheets are really for defining worker protection measures and don't translate to patient risk. I don't know that there is such a thing as a list of "safe" pest control products, but rather only products that are applied strictly according to their labeling, by qualified (and licensed where required) and only in approved quantities, forms and locations for specific pests.

Also, you can't rely on a contract pest control agent to implement your control procedures. They are actually trained by their employer to implement their pest control procedures and since you have likely not read their procedures, they need to be directly supervised by a trained responsible person. Also, be aware that the record book of service that they maintain "for you" at your facility is really for them and not you. I have personally witnessed pest control contractors remove those books , and report them destroyed, as part of their quality system. You must keep a separate set of facility pest control records if you want to be able to audit the pest control records without risk of interference/disappearance by the pest control contractor.

Disclaimer: I'm speaking about clean rooms used to make intracoronary products, not a food processing facility or facility where growth mediums are present. Theoretically, the only "critters" in the clean room are workers and the stuff that lives in and on the workers, which we protect against by worker hygiene and clothing.
 
D

DaisyMae

#10
Re: Pest Control procedure requirements???

Does anyone have a basic pest control procedure for a small OEM medical device company that they would be willing to share. We make plastic components and some finished goods for other companies (all non-sterile but built in cleanrooms)
We are just starting up and I have been tasked with setting up the pest control program and procedure.
Thanks to everyone. I love this site!
 
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