02.08.2016 |

LOGFILE No. 30/2016 – Don’t Be a Daredevil When Retrofitting Your Facility

Don’t Be a Daredevil When Retrofitting Your Facility

by Bob Ferer

When I was a kid, I used to collect leftover pieces of wood from my father‘s projects. My friends and I would build bicycle ramps used for jumping over obstacles (famed U.S. stuntman Evil Knievel was bug back then). Luckily, we didn‘t have iPhones and YouTube to record the outcome for all the world to view. From what I see, rigging together disparate materials to build something that fails remains a popular pastime.

In our industry, there exists an expectation for a facility to be purpose-built to our specifications. At the same time, regulators are keen to ensure companies demonstrate that the facilities are suitable. With mergers/acquisitions, as well as costcutting initiatives, however, facilities are being shut down and product lines consolidated into existing facilities - risking suboptimal layout and design. Certainly, I am not suggesting that our industry is building the equivalent of a backyard bicycle ramp, but as engineers and facility operations professionals, we sometimes may act as daredevils skating on that edge.

The placement of products into facilities not initially built for purpose does not necessarily present an objectionable practice if we understand the product and process requirements, and more importantly, the impact of the proposed new product/process within the facility. Contamination control for both microbial and chemical crosscontamination is an often overlooked assessment that should occur each time we plan to bring a product into a facility. It must also be a standard part of our change control process for new product introduction. The European Union has already issued instructions requiring the use of Quality Risk Management (QRM) principles to assess and control the risk of crosscontamination. These requirements are contained in the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part 1, Chapter 3: Premises and Equipment and Chapter 5: Production.

The risk assessment should start with understanding new product‘s vectors of contamination, and how these can impact existing products and processes in the facility The risk assessment should consider the current design of the facility, and how this may be sufficient (or deficient) to exclude the introduction and transmission of organisms and chemicals. This stage presents the perfect opportunity to correct deficiencies as corrections made during this phase occur before there is an adverse impact on existing operations. The following examples represent a few of the missteps I have seen in repurposing rooms. I hope these can help you avoid similar difficulties. Remember, the greatest risk in repurposing an area is lacking a full understanding of the original design.

Lack of Holistic Thinking = Disaster

A company decided to take an active tableting room out of service and utilize it as a clean parts storage area. It conducted a risk assessment, which found that the storage room presented less of a risk to 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 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 nontemperature-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 their 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 preparations 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 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.

Conclusion

Retrofitting of existing spaces is possible, and sometimes necessary to maximize effective use of existing infrastructure. These changes must be proactively assessed, however, and planned 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.

Author:

Bob Ferer, President
The Ferer Group
Charlotte, NC 28202, USA

The article was first published in the PDA Letter of February 2016 and is reprinted in our LOGFILE Newsletter by courtesy of PDA.

LOGFILE 30: Don’t Be a Daredevil When Retrofitting Your Facility.pdf

 
 
 

Comments