A poorly designed cleanroom can bring even the best processes to their knees. As such, designing a high-functioning, top quality facility from end to end requires holistic thinking.

In pharmaceutical, vaccine, and sterile manufacturing, the cleanroom environment is the major predicate for all manufacturing activity: without a proper background environment, no medicine can be produced for patient consumption. Today, there are a myriad of details individually assessed when building a new cleanroom or retrofitting an old one. Examples include construction materials, differential pressures and airflows, ergonomic features, and even lighting. There are reams of specifications for modular walls, air handling units (AHUs), flooring systems—the list goes on. Before the design team dives into those specifications, from the entry to the cleanroom to the exit from it, they must identify the real intentions for, and purpose of, the cleanroom.

The intentions and purpose are the reality of stable, reliant, and compliant operation within a tightly controlled and monitored environment. Different companies call this data by different names, such as Operational Philosophies or User Requirements (User Requirements will be used here). Functionally, this data should be captured in a document during the concept phase of the project, the content of which is agreed upon by the chartering team and is the foundation of all subsequent design activities.

A particular challenge for the Quality role on any project is defining User Requirements that are based on regulatory needs (published requirements, industry knowledge of agency action, or other sources). There are some simple regulatory requirements for airlocks that can inform early design. However, these requirements can often drive teams to focus on minute details before a holistic understanding of the requirements has been developed. For example, an FDA Guidance for Industry¹ states: “Air change rate is another important cleanroom design parameter. For Class 100,000 (ISO 8) supporting rooms, airflow sufficient to achieve at least 20 air changes per hour is typically acceptable.” Design requires hard numbers, so there is temptation for the design team to use this statement as a final Quality position—that 20 air changes is acceptable in a Grade C area.

Here is the risk: in doing that, the team has circumvented the appropriate User Requirement process. Whenever that occurs, it is possible to commit to delivering a project at a target cost or on a target schedule without understanding all drivers. To uphold the true intentions and purpose of the cleanroom, the Quality need is that the number of air changes in any room must adequately protect the product. In the airlock example above, if materials are being cleaned, decontaminated, and/or debagged for a demanding and continually-fed process, there is a chance that 20 air changes will not be adequate to maintain an active Grade C specification. Multiple people ripping open plastic bags and spraying disinfectant will certainly create a particle-rich environment.