Hello everyone.
A company located in the US is a contract manufacturer of medical devices and drug delivery devices.
They plan to engage in secondary packaging operations, such as inserting a prefilled syringe in a drug delivery device, in a dedicated part of the building.
Does this affect the infrastructure, eg HVAC, cleanrooms, of the entire facility? Do they have to change/improve/addapt the medical device production lines to also be compliant with pharmaceutical packaging requirements?
Thanks in advance for your input
A company located in the US is a contract manufacturer of medical devices and drug delivery devices.
They plan to engage in secondary packaging operations, such as inserting a prefilled syringe in a drug delivery device, in a dedicated part of the building.
Does this affect the infrastructure, eg HVAC, cleanrooms, of the entire facility? Do they have to change/improve/addapt the medical device production lines to also be compliant with pharmaceutical packaging requirements?
Thanks in advance for your input