Secondary packaging operations in medical device facility

paulag

Involved In Discussions
#1
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
 
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Ronen E

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#2
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
They will be making a combination device. I wouldn’t refe to it as “a packaging operation” (secondary or otherwise). Whatever requirements that apply to combination devices manufacturing, should be observed. Specific cleanliness requirements depend on the nature of the “drug delivery device” - you didn’t provide details about the method of delivery/operation; additionally, it’s not clear whether that device is supplied sterile and whether the prefilled syringe inclusion involves exposure of previously sealed parts of the device.

Either way, I don’t see how that should be applicable to the entire facility if they have a dedicated (properly segregated?) section specifically for that combination product, and have proper controls in their QMS.
 
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