Your CDMO's Maintenance, From Roof To Floor And Ever More
By Louis Garguilo, Chief Editor, Outsourced Pharma
Facility Maintenance –an all-encompassing descriptor.
It starts with taking care of an internal ecosphere, as our title suggests, everything from roof to floor.
It also includes an exosphere – the real estate the facilities sit on, the business parks where they are located, and the communities they reside within.
Ecosphere and exosphere come together via, for example, responsibility for water mains, utility wires, gas valves, transportation in and out, new equipment installation, and the like.
And when you are outsourcing, it makes you a part of it all as well. How much do you know about this area of your CDMO’s existence?
We spoke earlier with Hoff about how biopharma facility maintenance – including at the CDMOs you utilize – increasingly intersects with a facility’s operations.
He uses water as an example.
As many readers know, purified H2O is vital to the production of most medicinal products. Water systems at your CDMO should be an important part of your due diligence.
“When we are in charge of maintenance at a CDMO,” says Hoff, “we are typically in charge of the water used in production. In that sense, we are in fact part of the facility’s operations.”
“We are responsible for the Purified Water [PW] when produced for oral or external use, and Water for Injection” [WFI] when produced for parenteral use.”
With no pun intended, he says, “So that all runs through us.”
So do many other elements of a production facility.
Facility = Maintenance + Operations
While the individual components of facility maintenance are increasingly outsourced to a variety of third parties, JLL is a comprehensive maintenance-service organization.
In some cases, he says, “we're running all the utilities, the boilers, the chillers, watching that water 24/7. In summary, we have teams managing their soft services like janitorial, security, food service, landscaping, grounds, pest control and garments; and hard services, which include mechanical, HVAC and electrical systems, and lab and process instrument calibrations. We support these services throughout the day, and often across large sites.”
Additionally, as part of keeping biopharma facilities to the highest standards of cGMP regulations, Hoff’s team performs cleaning of process and manufacturing space between product runs.
“That’s something we never sub-contract out,” he says. “That's too close for comfort. I need to control that.”
Interesting, isn’t it? When we talk about operations, we usually refer to the FTEs you hire, the biologists, scientists, chemists, engineers, QA/QC and analytical support professionals, the project managers.
But Hoff’s team is involved with aspects of operations.
As a hypothetical, consider a CDMO needing to purchase and install new and advanced processing equipment – maybe for your project (as well as others). Guess who integrates into to the facility infrastructure, and tests it?
“We are involved,” says Hoff. “For us, it becomes a serious matter of how to effectively hook it up. Do we need design work, where’s the power coming from?”
“We may also do the main calibrations. I mean we are definitely talking about a responsibility that is dual operations and maintenance.”
Recently, a major storm produced a widespread power outage that affected a CDMO facility his team has responsibility for.
“We were there 24/7 for a few days, doing everything possible to ensure the place stayed online. We were running the generators, monitoring systems and equipment so no customer’s materials or products got impacted.”
It kind of makes you want to go out to your CDMO right now and meet the maintenance team, doesn’t it?
Cleaning Remembrances
I recall some stressful times when the CDMO I worked for had to discuss, plan out some specific SOPs, and document cleaning protocols for certain clients who were particularly in tune to the needs and importance of competent maintenance as a part of overall operations.
So it catches my ear when Hoff details how facilities commonly “outsource” maintenance activities.
“Oh yeah,” says Hoff, “external service providers are in there between batches – and for us, we operate at the beck and call of the client, and the client’s clients – your readers.”
But it’s not all about the manufacturing suites. “You've also got CNC [clean non-classified] space on the outside to maintain as well,” he says.
And his professionals undertake the same training as the CDMO's workers, “because that's the official book of record” for regulatory agencies and CDMO client audits.
“We actually utilize their training system. Then we have JLL quality and training teams oversee the work and ensure everything's done right the first time – and properly documented.”
Outsourcing Too Many Tasks
A final portion of my conversation with Hoff concerned what we might call “over-outsourcing,” or as he sees it, the need for – where have we heard this before? – an “all-services” model.
When his team is hired to come into a CDMO facility already outsourcing various maintenance activities, he puts a stop to some of those contracts.
He says, in too many cases, the CDMO has not been “outsourcing” per se, they have been “out-tasking.”
“They need a calibration on a piece of equipment, so they hire an individual to do just that. Before you know it, they’ve ‘out-tasked’ all these activities to different vendors.
“And by the way,” he adds, “your knowledge base goes out with the out-tasking, because the next time you need that contracted, you end up with a different person.”
“As another example,” he says, “we bring electrical work back in-house,” with “in-house” meaning under his purview.
Perhaps it is apropos to end our discussion on this very familiar OutsourcedPharma.com topic of whether one should work with a comprehensive external partner or select individual companies you might determine the best at each specific timing and need.
I do sense this: After two editorials with Hoff, you’ll be asking a lot more about all the maintenance strategies and professionals at your CDMOs. And your own facilities should you have them.