Facility of the Present

/// By Andrew Harris
There has been so much industry discussion and debate over the facility of the future construct (or FutureFacility™) and how it can be reimagined that sometimes we lose focus of the common pitfalls of young biotech and pharmaceutical commercial manufacturing facilities.

These are the plants that are still breaking in their equipment, personnel, procedures, automation, warehouse, supply chain and so on. Just like the sea trialing a new ship, facility and manufacturing managers are under constant pressure to stretch the legs of their plants to increase production and thus increase profits. Further, lowering the cost of goods relies on perceived efficiencies from pushing manufacturing capacity to its limits and sometimes beyond. It’s then that equipment failure, operational errors, contaminations and thus product loss tend to occur.

These challenges are inherent to a complex, precise and regulated industry. They also present a tremendous opportunity to solve our clients’ short-term problems in short order. As most of us know, managers at the healthiest of manufacturing facilities effectively pre-plan for product changeover windows and full plant shut downs to execute routine maintenance and equipment upgrades, as well as process improvement charters. Sometimes, immediate fixes are required to address an uptick in non-conformances (NCs) or to implement corrective actions in response to an FDA 483 citation. It is in our long-term interest to ensure we are giving our clients the absolute best feasible solutions to their short- term problems.

I recently heard a CRB colleague explain that our project managers’ #1 goal is to make their client PMs look like heroes (while making profit, of course). All projects, no matter how large or small the scope, have the potential for high visibility among our client’s upper management. Some of the high-risk deviations may have a very simple, low-cost corrective action that can prevent a high-cost failure. Even a pebble causes ripples across a big pond. Does your client have excessively long clean-in-place cycles? A high frequency of aborted sanitize-in-place cycles? An increasing level of NCs at a particular unit operation? Single-use component failures? Poor equipment ergonomics? Unmaintainable valves or elastomers? Under-defined PM requirements and historical records? Purification train bottlenecks? Vague or incomplete standard operating procedures? High manufacturing personnel turnover? Automation deficiencies? Over-modified equipment that no longer satisfies the user requirement specification? These are just some of the issues that can plague facilities’ manufacturing and engineering groups when they get too comfortable with tribal knowledge and the status quo. But many times, all of the issues our clients have are difficult to corral without a holistic approach to root cause analysis.

CRB has an impressive portfolio of services beyond full-service design and construction: operational improvements, process debottlenecking, Computational Fluid Dynamics (CFD) modeling and regulatory compliance consulting, just to name a few. But another service of ours that I have seen lead to sudden, sole-sourced RFPs from clients is the risk assessment. This tool has the power to unearth projects that our clients didn’t even know were there. And once the results are in print, in front of our clients’ quality representative(s), the moderate-to-high-risk issues for patients are impossible to ignore and oftentimes require immediate remediation through corrective and preventive actions (CAPAs).

Two risk assessments of note were recently conducted at two confidential clients. The results of these exercises are only as good as the comprehensive, unbiased feedback we receive from the Owners, so we strongly encouraged subject matter experts (SMEs) from project management, manufacturing, facilities and engineering, technical operations/transfer, quality, validation and regulatory departments attend. The execution took approximately one to two weeks, depending on the scope of work and availability of SMEs. With approval from the Owners’ Quality Team, both risk assessments exceeded 100 recommendations, which represents a potential projects stipulated by CAPAs. As we have seen with these two confidential clients, comprehensive risk assessments have translated into $35 million total installed cost of retrofit work, and more importantly, these clients witnessed CRB’s relentless pursuit of [their] success.

 As CRB has grown, so has our capability to execute large-scale projects. While these successful endeavors certainly bolster our qualifications and industry reputation, it’s the small projects that lay the foundation for long-term client relationships and success. 

About the Author

Andrew Harris, Process Engineer

Andrew Harris, Process Engineer

Andrew Harris is a Process Engineer at CRB in our Philadelphia, Pennsylvania office.

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