Requirements ISO 13485:2016

[Markus 83]

Hello everyone
we are a plastic injection molding company and we are getting 9001 certified. Now there is an opportunity for some products but would require ISO13485 certification.
I am a little bit confused about all the requirements of clean rooms. I know it depends on the product itself but what are additional changes we have to implement in our facility? We are located in Florida and we are not air conditioned. The products would be class 2.

Do we need to create a clean room for those? also do we have to implement new ventilation systems? What kind of more documentations are required during the entire manufacturing process from purchasing to receiving, testing, molding, inspection and traceability?

Thank you in advance for your help

 

[blackholequasar]

Good morning! Will you be providing a sterile component? Is it a finished product or just a sub-component into a larger build?

 

[Philip B]

Whether you need a cleanroom or not is a question without an easy answer. Are you the legal manufacturer of the devices yourselves or are you making components for others? If for others, what are the expectations of your customers in terms of contamination control (both particulate and microbiological)? Are they cleaning or sterilising the devices themselves and therefore your own controls might be less critical? Building even a low grade cleanroom big enough to do injection molding will be a big and costly enterprise. Converting an existing building into a cleanroom is normally problematic, they just aren't designed for the job. You need to consider in detail the expectations for the devices and also whether this marketplace is worth the investment. HTH.

 

[ECHO]

Another strategy is to ask one of your existing customers.
Your medical device customers have a vested interest in helping y'all meet these regulatory goals.

 

[Markus 83]

Good morning! Will you be providing a sterile component? Is it a finished product or just a sub-component into a larger build?

It is a finished 1 component product. it will be for baby care

 

[Markus 83]

Whether you need a cleanroom or not is a question without an easy answer. Are you the legal manufacturer of the devices yourselves or are you making components for others? If for others, what are the expectations of your customers in terms of contamination control (both particulate and microbiological)? Are they cleaning or sterilising the devices themselves and therefore your own controls might be less critical? Building even a low grade cleanroom big enough to do injection molding will be a big and costly enterprise. Converting an existing building into a cleanroom is normally problematic, they just aren't designed for the job. You need to consider in detail the expectations for the devices and also whether this marketplace is worth the investment. HTH.

we will make the 1 component finished product but it is not sold through us. but it will be readily packed for retail.
Yes it will be very costly to build it around the injection machine.

 

[Markus 83]

Another strategy is to ask one of your existing customers.
Your medical device customers have a vested interest in helping y'all meet these regulatory goals.

thank you for your advise

 

[ChrisM]

Who is the Design Authority for the products that you think may require clean room conditions? If you are "just" an injection molding company working for someone else, then that "someone else" needs to define the cleanliness standards required to manufacture the parts of the product, and you would have to demonstrate compliance. If however this is going to be a product that you yourselves have designed, then your own design and manufacturing requirements specifications should establish what is required and so long as you meet the requirements of FDA, ISO13485 etc, you should be OK.

 

[Markus 83]

Who is the Design Authority for the products that you think may require clean room conditions? If you are "just" an injection molding company working for someone else, then that "someone else" needs to define the cleanliness standards required to manufacture the parts of the product, and you would have to demonstrate compliance. If however this is going to be a product that you yourselves have designed, then your own design and manufacturing requirements specifications should establish what is required and so long as you meet the requirements of FDA, ISO13485 etc, you should be OK.

Chris

Thank you for your reply.
It is the customers design and we are just molding it.

It is a class 1. I got a little bit confused by the classifications. The product itself is a class one, but that does not mean that we need a class 1 clean room, correct?

Class 1 devices are perceived to be the lowest risk devices. A formal review (i.e., 510(k) or PMA) is not typically required. General Controls are usually sufficient. Approximately ¾ of all devices listed with the FDA each year are Class 1. Examples include medical tape and bandages.

 

[ChrisM]

My understanding is that your customer has to specify the cleanroom standard, if applicable. When they conducted their assessment process to select a suitable supplier, they should have visited you and established what criteria were required, from cleanroom to any in-process sampling inspection required, how results of any such inspections or tests are to be communicated to them etc. If you are sufficiently concerned, you should contact them and confirm that your existing cleanliness standards meet their requirements.