I am pretty sure this topic has been discussed ad nauseum but a search to find specifics can be aggravating.
I work for a medical device component manufacturer (ISO 13485 certified and FDA registered) and we do not sterilize product before it is delivered to our Customers. We are a machine shop that manufactures in job lot sizes for many different Customers. We have a very sophisticated final clean station that has just completed the IQ, OQ and PQ validations as well as in-process cleaning stations used to remove the processing fluids that are normal to a machine shop environment going from one process to another. All our product goes through the final clean and then a final inspection (In a controlled environment room, not a clean room) before leaving the facility.
We have been told by the FDA as well as a couple high level Customers that personnel eating on the production floor is not acceptable. We get the thought process that brings that about and are well aware of the sections in the CFR that pertain to contaminatio which, by the way, do not "prohibit" the consumption of food in the manufacturing areas but in our view pertain to the potential invitation of pests. Our cleaning equipment (although not specifically validated for food particles) is capable of removing manufacturing oils and such and as such should be able to address the reasonable attempt to prevent contamination from any substance that could reasonably be expected to have an adverse effect on product quality from reaching the Customer.
We are prepared to institute a no foods or drinks policy with the exception of water, on the manufacturing areas. My question to those that have instituted such a policy is,
I work for a medical device component manufacturer (ISO 13485 certified and FDA registered) and we do not sterilize product before it is delivered to our Customers. We are a machine shop that manufactures in job lot sizes for many different Customers. We have a very sophisticated final clean station that has just completed the IQ, OQ and PQ validations as well as in-process cleaning stations used to remove the processing fluids that are normal to a machine shop environment going from one process to another. All our product goes through the final clean and then a final inspection (In a controlled environment room, not a clean room) before leaving the facility.
We have been told by the FDA as well as a couple high level Customers that personnel eating on the production floor is not acceptable. We get the thought process that brings that about and are well aware of the sections in the CFR that pertain to contaminatio which, by the way, do not "prohibit" the consumption of food in the manufacturing areas but in our view pertain to the potential invitation of pests. Our cleaning equipment (although not specifically validated for food particles) is capable of removing manufacturing oils and such and as such should be able to address the reasonable attempt to prevent contamination from any substance that could reasonably be expected to have an adverse effect on product quality from reaching the Customer.
We are prepared to institute a no foods or drinks policy with the exception of water, on the manufacturing areas. My question to those that have instituted such a policy is,
- has this policy extended into the business office areas (away from the manufacturing areas) as well?
- If so, how have the conference areas been included into this policy especially during Customer visits with coffee and lunch (many Customers prefer a working lunch).
- How have hard candies and cough drops been addressed? Many operators have voiced a concern that they use these items to relieve dry throat and coughs.
