If you’ve been in this business long enough, you’ve most likely run across the need to decommission cGMP equipment or facilities. On the surface, this may look as simple as turning the power and other utilities off, disconnecting them, and removing the equipment or facility in question. Looking deeper however, there are a few other considerations.
The tasks that need to be undertaken fall into 3 main categories:
Regulatory Compliance
Safety
Resale value
Regulatory Compliance - First, anything that was formerly used to manufacture pharmaceutical or biopharmaceutical products will need to have a few things completed before you disconnect the utilities. Namely:
The equipment should be cleaned per the appropriate SOP and the cleaning should be documented.
Ensure the last product produced has been fully released.
Ensure all products produced in the equipment and still on the market do not have any customer complaints outstanding.
Gather and archive all documentation associated with the equipment including URS, IQ/OQ/PQ documentation, cleaning validation documents, maintenance records, investigations, change control records, equipment logs, etc.This will be vital for any future product complaint investigations as well as increasing the value to a potential buyer.
Check the calibration of all critical instruments to document that they were still within the desired tolerance at the end of the last batch.If not, perform an investigation to determine if any out of tolerance condition had product impact.
Fill out the required change control paperwork to document the when, why, and how the equipment will be taken out of service.
If the system has any data implications, or Part 11 qualification, any stored data will need to be archived in a manner to ensure that it is retrievable.
All of the above information should be archived in an equipment history file. This will most likely consist of both electronic and paper records, so be sure each references the other for ease of future retrieval.
Safety - all sources of energy will need to be turned off, locked and tagged to prevent any unintended release of that energy. This will include not only utilities like power, compressed gasses, steam, water, etc. but potentially other sources of stored energy like hydraulics and pneumatics. Any stored energy still inherent in the equipment should be released before long term storage or sale.
If the equipment is to be sold, ensure that the utilities are disconnected in a manner that will make it easy for the buyer to reconnect them (i.e. ensure no damage is done to the equipment like cutting wires, tubing etc.)
Process utilities and drain lines should be drained, cleaned and dried. Any air flow path components with internal particulates should be cleaned. Any process filters should be removed and destroyed and the housings thoroughly cleaned of any source of contamination. Ideally, new filters should be installed prior storage or sale unless the filter media is prone to insect infestation or breakdown over time. For inaccessible parts of the equipment, a camera should be inserted to ensure all sources of contamination are removed.
Resale Value - If the equipment or facility is to be sold or shipped, all of the appropriate documentation should be gathered including the URS, validation documents, user manuals, drawings, cleaning validation, etc.
All external openings should be capped in some manner to prevent pest infestation.
Company logos should be removed or defaced.
Lastly, all of the above steps should be documented in a checklist and signed by the person(s) responsible and the change control closed out.
Decommissioning is just as important to biopharmaceutical equipment as commissioning is. If done incorrectly, it could lead to sanctions by regulatory authorities or reduced value on the used equipment market. Don’t let this happen to you!