Why Completion of Construction Is Not the Same as Readiness for Production
In the first article of this series, we discussed what a cleanroom is and which cleanliness classes are regulated by the ISO 14644 standard. We mentioned there that classification is performed separately for three different states of the room, and it is precisely this distinction that explains why a building that has passed final inspection is not yet ready for operation. Technical acceptance confirms the “as-built” condition—that is, that the ventilation, filtration, and other systems operate according to the design, when the room is still empty of both equipment and people. This is an important stage, but it speaks only to the room’s potential, not to its actual performance during operation. Before the first batch of product enters the cleanroom, it must undergo a qualification process that verifies whether the room maintains the required cleanliness class even when equipment is operating and people are moving around—that is, under conditions much more challenging than those during a dry construction acceptance.
The Three Stages of a Room in the Qualification Process
The ISO 14644-1 standard refers to these three situations as the “as-built” state, the “at rest” state, and the “in operation” state, and each plays a different role in the process of certifying a cleanroom for operation. The “as-built” condition is tested immediately after installation work is completed, before furniture, production equipment, or tools are brought in. This provides the first evidence that the room’s structure itself meets the design specifications. The “at rest” state is tested with all equipment fully operational and powered on, but without personnel present. This measurement shows how the room behaves when all sources of heat and vibration—such as motors and lighting—are already running, even though no one has entered yet. The “in-operation” state is the most demanding stage, as it accounts for normal team operations, doors being opened, the movement of people between zones, and typical production activities. It is this state that demonstrates whether the room will actually maintain its declared cleanliness class under everyday—rather than laboratory—conditions, and it is this state that ultimately determines whether the room is approved for production.
What Does Cleanroom Qualification Entail?
In industrial practice, particularly in the pharmaceutical and biotechnology sectors, the process of verifying a facility’s readiness is divided into three interrelated stages, known by the acronyms IQ, OQ, and PQ. Installation Qualification, or IQ, verifies that all equipment and systems have been installed in accordance with the design documentation and the supplier’s specifications. This is the stage at which what is actually present in the facility is compared with what was planned on paper. Operational Qualification, abbreviated as OQ (from Operational Qualification), confirms that the installed systems operate within the entire intended range of parameters—for example, that the ventilation system maintains the appropriate number of air changes per hour and that the pressure differential between zones remains within the specified limits, regardless of the load.
Process qualification, or PQ (short for Performance Qualification), is the final and most demanding stage, during which it is verified whether the facility meets all requirements during typical, repeatable operation—that is, precisely in the “in-service” state we discussed earlier. Only a positive outcome at this stage provides a solid basis for starting production. Each of these three stages concludes with a document, not just a meter reading. The qualification report describes what was tested, the method used, the results obtained, and who is responsible for each measurement; all documentation is then archived, where it serves as the basis for demonstrating compliance during future audits.
Initial Setup and the First Few Days of Operation
When the process qualification is successfully completed, the room is formally approved for production; however, this moment itself involves several organizational decisions that are easy to overlook when focusing exclusively on technical parameters. Permissions must be granted to specific operators who will be authorized to enter the room and change its status. A team must be designated and trained on entry and exit procedures, including the proper sequence for putting on and taking off protective clothing. It is also necessary to decide which room statuses will be distinguished in day-to-day operations—for example, “ready for production,” “being cleaned,” or “awaiting approval from the quality department”—and who is authorized to make which changes. It is at this point that the room ceases to be an engineering project and becomes the team’s daily workplace, complete with all the accompanying documentation, which we discussed in greater detail in our previous article on cleanroom operations.
Why is this moment a good starting point for digital status management?
The experience of many facilities points to one consistent pattern: It is much easier to implement a digital room status management system from the very start of operations than to transition a team from paper forms to a digital system while production is already underway. The first day of operation in a facility is a natural time to train operators, establish procedures, and build habits, so it’s important for them to learn the correct, intended way of working right away, rather than first reinforcing habits associated with paper and then having to unlearn them. There is also a documentation benefit to this. If the digital system begins recording the room’s history from the very first day of production, the quality department has, from the very start, a complete, continuous, and immutable record—with no gap between qualification and daily operation that would later need to be explained during an audit. We describe exactly this kind of system—which combines a simple operator panel at the door with automatic logging of every status change in the Audit Trail—on the page “Clean Room Statuses with Audit Trail.” This solution works equally well when commissioning a new room and when digitizing those that have been operating for years using paper documentation.
Summary
The path from project completion to the first production batch involves installation, operational, and process qualification, and each of these stages concludes with a document confirming that the room maintains the required cleanliness class not only at rest but also under the demands of daily operations. The moment of the initial startup is also the best opportunity to implement digital management of the room’s status from the very beginning, rather than postponing this change for later. You can read more about what a cleanroom is and what its day-to-day operation looks like in the first and second articles in this series.
Sources:
- Norma PN-EN ISO 14644-1:2016 (zgodna z EN ISO 14644-1:2015);
- Norma PN-EN ISO 14644-3 — metody badań stosowane w procesie kwalifikacji;
- Rozporządzenie Ministra Zdrowia z dnia 9 listopada 2015 r. w sprawie wymagań Dobrej Praktyki Wytwarzania, Załącznik nr 5, Aneks 1, w brzmieniu obowiązującym od 18 grudnia 2024 r.
