Building Heavy Pollution Factory next to Medical Device Factory (ISO 13485)

kapinka

Starting to get Involved
#1
Hello friends,

I couldn't find any discussion about this issue, and I need opinions from you, or maybe someone has some experience about it.

We are a Medical Device Factory working in an area where an investor wants to build up a HEAVY POLLUTING FACTORY (for production of bio diesel fuel by using burned oil mainly and other used materials) within less than a kilometer from our factory.

Do you know if somewhere I can find any prohibitions or permissions, or any relevant document, standard to refer to? Is there really a bad impact on our production or no?
If I'm in the correct place for discussions, you are more than welcome to share your opinion. Thanks!
 
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rob73

looking for answers
#2
Re: Building heavy pollution factory next to Medical Device Factory (ISO 13485)?

It depends in which part of the world you are in. In the UK I would be speaking to our local planning officer for details of the new build to see what (if any) impact it could have on us.
Rob
 
S

Sarah Stec

#3
Re: Building heavy pollution factory next to Medical Device Factory (ISO 13485)?

I agree that it depends on the part of the world you're in. Speaking (typing) not as an employee of a NB, you may want to contact a lawyer in your jurisdiction that specializes in real property law and see what you can do. You can also speak to your local planning office to see what they're building, the building and environmental codes they must comply with, etc. From a US legal perspective, your ISO standards don't have anything to do with who gets to build factories near you.

Full disclosure: I'm a US lawyer, also an employee of a NB. Obviously, the above wasn't written in my capacity as an employee of a NB, since NBs (or at least mine) don't practice real property law. :)
 
S

samsung

#4
Re: Building heavy pollution factory next to Medical Device Factory (ISO 13485)?

Hello friends,

I couldn't find any discussion about this issue, and I need opinions from you, or maybe someone has some experience about it.

We are a Medical Device Factory working in an area where an investor wants to build up a HEAVY POLLUTING FACTORY (for production of bio diesel fuel by using burned oil mainly and other used materials) within less than a kilometer from our factory.

Do you know if somewhere I can find any prohibitions or permissions, or any relevant document, standard to refer to? Is there really a bad impact on our production or no?
If I'm in the correct place for discussions, you are more than welcome to share your opinion. Thanks!
The factory that's proposed to be set up in your vicinity may not necessarily pollute the environment though it might have enormous 'potential' to pollute since no government can ever permit anyone, whosoever, to indiscriminately pollute the surroundings.

In many countries, the environmental legislation require:
- an upfront assessment of the potential environmental impacts that the project would have on the surroundings,
- mitigation/ control plans,
- Baseline as well as post project monitoring of local surroundings,
- Continuous monitoring & measurement of critical pollutants (if it's suspected that the pollutants would otherwise be detrimental to human health or to general environment)

Normally the 'clearance' is granted once the evaluator (or the committee) is satisfied with the proposed arrangements for prevention/control of pollution. Such reports are generally made available to public by the respective government bodies; or atleast to those who are likely to be impacted directly or indirectly, can rightfully have access to such information. In many cases, even 'public consultation/ hearing' is also undertaken by the concerned authorities in order to seek public opinion on the proposals made by the proponent.

Hope it gives some insight.
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: Building heavy pollution factory next to Medical Device Factory (ISO 13485)?

Hi,

Apart from all the above, "medical device manufacturing" is an awfully broad term. What kind of devices you make? In what sort of production environment? What controls (if any) do you have in place? And also, besides "heavily polluting" did you actually find out what sort of pollution is expected (in terms of substances, quantities, modes etc.)?

Just as an illustration - making IV set components in a cleanroom environment is not the same as contract manufacturing PCBs for medical equipment or building hospital (therapeutic) furniture.

I'm not in for environmental pollution or breaking planning rules and regulations, but in your own context it doesn't necessarily have to be so bad.
 

kapinka

Starting to get Involved
#6
Hi guys!

First of all thanks to all for the efforts to help me learn more on the topic!

If the standards or European directives do not have any requirements on the issue, then we shouldn't be worried probably.

The answers to your questions below:
We are located in Southeastern Europe, we are producing medical devices class IIA (AV sets, catheters, infusion lines).
There was a public consultation/ hearing undertaken by the state institutions in order to seek public opinion on the proposals made by the proponent. During the first public hearing (3-4 months ago) was asked from the investor to submit to the public assessment for the potential risks in the air, ground, water and specifications for the pollution. They say they have ecological and closed functioning system without any impact but by the state authorities they are categorized as G2 or heavy pollutants. And the arguable factory "will store and process dangerous waste to produce bio diesel fuel".
 
Last edited:

harry

Super Moderator
#7
....................... the state authorities they are categorized as G2 or heavy pollutants. And the arguable factory says: "will store and process dangerous waste".
Whether they are heavy or light polluters, they all need to meet the same requirements and discharge limitations prescribed by you local environmental laws.
 
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