The Nonlinearity Conundrum In Pharmaceutical Facility Design
By Geoff Middleton
In the pharmaceutical and biologics manufacturing community, we’ve been instilled with a unified and rigorous direction with respect to capital project execution. The emphasis is speed, and rightfully so. These projects are among the most complex and costly in facility construction; not to mention that, given the revenue at risk, the overarching focus on speed to market is undeniable. Understandably, the best methodologies of project management — with all its sophisticated tools of the most current thinking — are brought to bear. A strong focus on linear forward progress is always at the fore: initiate, achieve goal one, then goal two … finally finish.
The problem is, at the outset of design — at the very earliest activities in concept design — this linear approach is costing both capital and operating budgets many millions of dollars, simply because best practices in early design are not linear. The inherent nature of early design is iterative. Forcing it into a linear pattern robs the designer of the tools needed for excellent design.
In fact, due to the classic focus on linearity of modern management thinking, facility designers in our industry simply practice their early design efforts furtively, behind closed doors. Even then, their efforts are stilted and terminated early. The first viable solution is all too often adopted without further consideration.
The result is waste: significant capital opportunity lost, increased operating costs for the life of manufacturing facilities, and, as a direct result, increased cost of goods.
More Independent Variables Is Better, Not Easier
The very fuel of design is the layer upon layer of uncertainty inherent at the start of any design effort. As the design proceeds, avenues are examined and evaluated. Along the way, more variables are nearly always uncovered. In a way that seems counterintuitive, the designer and the design thrive on these independent variables. The more, the better.
The designer is taught to hold in suspension all the uncertainty, all the variables, as long as practicable. An integral part of the education of a designer is to learn not to “fall in love” with a design — to avoid becoming infatuated with the many desirable aspects of the current scheme that sits on their table or computer monitor. Another approach, another scheme beckons, with even greater advantages.
To prematurely remove these variables is to rob the effort of momentum, just as it builds speed, energy, and focus. There is a technical name for this narrowing action: reductionism. To make a complex problem more easily solved by artificially neutralizing elements within it. Fortunately, all the elements count; each represents an aspect of the actual, practical, real problem statement. Eliminating them one by one simply leads to simplistic design, lacking in elegance and efficiency.
The Design Manual
A salient and frequently encountered example of reductionism in pharmaceutical facility design is the corporate design manual. Many large and sophisticated manufacturers that find themselves repeatedly faced with design efforts chartering large capital projects author corporate design manuals. Often these are detailed and specific. The underlying — and clearly justified — reasoning behind design manuals is to bring consistency to multiple projects, each dealing with largely similar elements and issues. In most cases, and for many issues, these manuals are quite useful to the designer, answering routine questions that would otherwise absorb valuable time in back and forth, question and answer.
The problem arises when these manuals venture into design example by illustration, and the design team takes the resultant, often oversimplified, diagram as gospel — to be followed blindly and without further examination.
As valuable as a design manual’s illustrations may be in communicating intent, nothing can replace the value of wrestling with all the variables and producing a custom-fit project design.
Culture at the Beginning of the Design Process
That this diversion from classic design practice has occurred in pharmaceutical facility design is due in no small part to the culture of capital projects groups — both within operating companies and at design firms — imposing itself on these early design efforts.
The evolution of a capital project is, in many ways, similar to the evolution of a new drug product. At the outset, researchers find a promising candidate for a particular indication. The molecule is then transferred to a development team, which sorts through a myriad of potential variations and approaches to commercial manufacture. At the onset of clinical manufacture, the rules, restrictions, and expectations of cGMP manufacturing are brought to bear. At full-scale commercial manufacture, the last wisps of flexibility and variability are exiled from the process, in favor of the highly controlled and characterized repeatability of current good manufacturing practices (cGMPs).
Parallels may be drawn between the life cycle of a new pharmaceutical product being discovered and brought to market, and the stages of a capital project design. Researchers at the discovery stage are similar in many ways to concept designers for a capital project. Development of that potential new product, where rigorous refinement and scale-up of the process is undertaken, is mirrored in the preliminary design phase of a capital project design. Clinical manufacturing of the product introduces the rigor of cGMPs in a way similar to the highly detailed and constrained production of drawings and specifications for a capital project. These parallels meet in the constructed and operating commercial manufacturing facility, and its validated procedures and processes.
Like the designer, the researcher thrives on open-ended questions. Researchers are sought after for their education, skills, and knowledge, but not least of all for their inquisitive and inventive minds. We would not suggest that the researcher continue their involvement into the realm of cGMP manufacture. These are simply different people, with different qualities and capabilities. Little good would come from the cultural clash that would result from the management of manufacturing being put in charge of research and development. In the world of capital projects, however, this is precisely current practice.
Beyond the urgency felt by the entire project team, management — steeped in execution strategy and modern management theory and tools — does not recognize the processes their designers use, and are made viscerally uncomfortable by that unfamiliarity. How are they to gage progress? What will they tell their superiors? What are the designers doing now?
The Means and Ends are One
It sounds obvious, but a poor process will inevitably lead to a conclusion that is less than optimal. Unfortunately, the misguided emphasis on linearity and speed does not return the desired result. A more efficient design assuredly results from a more thoroughgoing design process. And while incremental time may accrue during the initial design phases, such an optimized design will be completed more quickly in detailed design, construction, and validation — more than making up for the initial time investment, and leading to a facility that is less expensive to build, validate, and operate.
As the pharmaceutical and biologics industry matures, and as governments and insurance companies apply ever-greater pressure on the cost of treatments, we increasingly can ill afford inefficient, less-than-optimal facility designs … if ever we could. Clearly, a new/traditional approach is called for.
About the Author:
Geoff Middleton is a process architect with over 30 years of programming and design experience in the Pharmaceutical, Biologics, and Regulated Industries, working for both Jacobs Engineering and Life Sciences International before starting cGMA in 2004 and IDEA2.0 in 2014. Geoff’s expertise is in early- stage decision making, feasibility studies, site selection, programming, master planning, and conceptual design.