In Part 1 of “Don’t Be a Daredevil When Retrofitting Your Facility,” I laid the groundwork covering why a disciplined approach needs to be taken when repurposing rooms, particularly when new management is taking a different approach in an existing facility.
In this Part 2, I present a few of the retrofitting-gone-wrong examples I have seen in my years in the field. Each of these examples happened in established, well-known companies that, when faced with the need to repurpose a room, decided to daredevil it a bit instead of going back to a detailed blueprint.
In example number one, a company decided to take an active tableting room out of service and utilize it as a clean parts storage area. They conducted a risk assessment, which found that the storage room presented less of a risk to the product than as an active tableting room. The firm felt that the room air supply filtration and active air changes were well in excess of that needed for a storage room, choosing to leave that functionality in place to save time.
The company failed to recognize, however, that the filling room was designed for negative pressure to the hallway due to potential dust generation of the tableting operation. As a clean parts storage room, the proper design is to have the room be positive pressure to the hallway to prevent migration of particulate into the storage space.
In another example, a room originally designed as a small parts washroom was repurposed to wash larger equipment, including portable tanks. Engineers focused on the plumbing availability in the space, concluding that the drains could handle the larger quantity of water used as the primary utility in a wash bay, but they failed to consider the impact to other utilities within the space. The Air Handling Units (AHU), for example, did not have the capacity to remove the excess heat and moisture generated by the new washing processes and failed to keep the room in a state of control during use, impacting nearby rooms as well.
Secondly, the AHUs did not have the ability to keep the moisture in the vapor phase as the uninsulated duct work passed through non-temperature-controlled mechanical spaces prior to venting outside. While it is not uncommon for exhaust ductwork to remain uninsulated as there is no energy efficiency to be reclaimed, in this case, the moisture collected on the ductwork, dripped back down the duct, and leaked into interstitial and mechanical spaces. Needless to say, a mold problem ensued.
In another case, a firm decided to expand its production area because of an expected increase in manufacturing orders. It correctly isolated construction zones from the current manufacturing areas and proceeded to build and validate the new processing rooms. When the new processing rooms were put into service, it put an increased load on the existing preparation areas. As a result, more supplies were needed in the preparations room, and work in process was also being accumulated. Operators were unaware that the additional materials were disrupting the airflow in the room due to partial obstruction of low wall returns. The airflow disruption negatively affected the environmental monitoring results of the room, leading to high viable and nonviable particle counts. The engineers failed to account for the impact on the other production spaces during the planning for their new production rooms. While the equipment was physically capable of handling the increased capacity, the staging before and after processing was not considered. This led to employees “making do”—violating the operating principles of the space.
In sum, retrofitting existing spaces is possible, and sometimes necessary to maximize the effective use of existing infrastructure, but these changes must be proactively assessed and planned carefully in advance of product line consolidation. Only then can we ensure that the facility is purpose-built and will not become a patchwork activity that regulators will refuse to approve.
QxP Vice President Bob Ferer is a 30-year veteran in pharma. Prior to joining QxP, Bob worked with Sanofi Pasteur on a building / process train renovation. His role for Sanofi was to support the team from a compliance and regulatory aspect for the testing, qualification, and validation for all critical utilities, equipment, systems, and processes. Bob’s experience and insights have been very valuable to QxP clients.
