The problem becomes even bigger when a smaller short-term project kicks in. A new water treatment for example. Capacity is measured roughly then, manuals from existing machines kick in, lower/higher consumption rates from nominal are not met, a spare capacity is added and there you are, the team has a new user requirements specification (URS) where real data is not always calculated. Vendors then require URS and a consumption list, which they often must resolve themselves through fragmented reverse engineering.
On the other hand, there are numerous projects that keep using a full chain of custody:
Analysis-> Scope-> Conceptual Design -> Basic Design ->Detailed Engineering
Conceptual engineering isn't bureaucracy; it's the phase where an idea is evaluated to determine whether it makes sense before real money is spent. It’s the engineering proof of concept. The process logic is defined, utility loads are established, site constraints are checked, and a reliable budget range is developed. Without it, layout decisions and room classification calls are based on assumptions that no one has tested.
What follows is basic engineering process flow diagrams, mass balances, equipment lists, instrumentation philosophy- and together these two phases typically represent no more than 5-10 percent of the total project cost; yet they define the outcome of everything else.
This is the monetizing phase of the idea, where Finance department starts to perform calculations, human resources gets involved with personnel dimension, while plant managers and leaders across all levels get involved and are part of planning the project, being part of the solution. Rather than having a solution imposed on end users, stakeholders become engaged contributors to its development. Thus, ownership of the project is shared across the organization.
A plant is a hive. Modulating an idea is modulating a risk of failure and experience blends with engineering.
Fundamentally, engineering is not a science. It is a behavioral and experimental monitoring and supervision of experience. Engineering tools support projects. However, these tools need input and cross-functional teams to deliver solid data from the shop floor.
Nowhere in a pharmaceutical industry practice is this principle more obvious than when writing a URS. A URS for a purified water generator, a tableting machine, or an environmental monitoring system/manufacturing execution system should be a precise technical document and not something pulled from a supplier's template or recycled from a project done five years ago. When basic engineering has been done properly, the URS reflects real process conditions: validated flow rates, confirmed material compatibility, defined utility connections. Without that groundwork, the result is a document that cannot provide protection when something does not at commissioning. This should come as no surprise, though it is often treated as one.
Another example is when revamping existing facilities. This can be harder than building new facilities, and this is where skipping conceptual work causes the most damage. What lies behind that is not known until it is opened. A proper conceptual study maps the clashes between new and existing systems, surfaces regulatory implications of layout changes, and identifies hidden costs before contracts are signed. Change orders during construction are costly, and qualification failures even more so; yet both are largely preventable.
Deliverables of Pharmaceutical Engineering:
- Conceptual design, so the feasibility of the project is reached
- Risk analysis and capacity study, so the investment is protected
- Cost estimation, so all business owners give input
- Layouts, flows, classification (subject to regulatory audit)
- Basis of design and technical description, so technical details of the equipment and utilities are covered
Basic engineering provides boots-on-the-ground teams with what and how to procure everything. In the basic engineering phase, diagrams, process flows and basic criteria (e.g., calculations for HVAC) are given to contractors, vendors, engineers for detailed engineering.
Decisions made at the conceptual stage (e.g., equipment placement, utility routing, cleanroom classification, material flow) can be inexpensive to change on paper but brutally expensive to fix once steel is in the ground. Skipping this work doesn't accelerate a project; it just shifts the cost to the worst possible moment: mid-construction, or worse, during qualification. A well-executed conceptual engineering package aligns the process, the facility, and the regulatory strategy before anyone commits serious capital. It forces the right conversations early between process engineers, quality assurance teams, and operations teams, so that gaps in GMP compliance or containment strategy surface in a meeting room, not during an US Food and Drug Administration pre-approval inspection.
The ISPE community has a significant role to play in changing how the pharmaceutical industry approaches early-stage engineering. It’s not process for process’s shake; the decisions in the first 10 percent of a project shape 80 percent of the result. The guidance documents, including ISPE Baseline® Guides, provide best practice frameworks. What is needed is for the discipline to use them from day one, on every project, regardless of size, not just on the big greenfield build outs, but also on the URS for a single piece of equipment.
The investment is small; the alternative, repeatedly expensive.
