Why Building a Cleanroom Alone Isn't Enough
In our previous article, we explained what a cleanroom is and which cleanliness classes are regulated by the ISO 14644 standard. Meeting the required class during the cleanroom’s acceptance confirms that the installation and ventilation systems are operating as designed. However, it says nothing about what happens in the room on a daily basis, who enters it, what its current condition is, or whether every change in that condition has been properly documented. This day-to-day, operational aspect of cleanroom operations can be just as critical to product quality as the air cleanliness class itself, yet it is discussed far less frequently.
What is the standard procedure for managing room status?
In many facilities, the status of a room—for example, whether cleaning is in progress, whether the room is awaiting clearance from the quality department, or whether it is ready for production—is still recorded by hand on a paper card pinned to the door. The operator writes down the date, time, their first and last name, and the new status, often under time pressure, between one task and the next. This way of working has several weaknesses that only become apparent over time. The card can get lost, get wet, or be filled out illegibly. An entry can be corrected with a pen after the fact, which in itself undermines its credibility. It is also not always possible to unequivocally determine whether the person who made the entry was actually authorized to do so, especially when several operators are working on the same room during a shift change.
What are the risks associated with manual documentation?
The risks associated with paper-based documentation become most apparent during an audit or inspection, when it is necessary to demonstrate a complete and reliable history of a room’s status over a given period. In industries regulated by the FDA—including, among others, pharmaceuticals, biotechnology, and medical device manufacturing—electronic records that replace paper documentation must comply with the requirements of 21 CFR Part 11, which pertains to electronic records and signatures. Among other things, this regulation requires that an audit trail be automatically generated by the system, time-stamped, and that no change can overwrite or delete previously recorded information. By definition, a paper log does not meet any of these conditions, because each entry can be physically altered, and the document itself does not generate an automatic, independent record of every modification. In practice, this means that the quality department, when preparing for an audit, spends many hours manually collecting, organizing, and translating the entries from the cards into a legible report—and yet there is no guarantee that such a report will stand up to a thorough auditor.
How Digitalization Is Changing Our Daily Work
The direction of change in the industry is quite clear today. BMS (Building Management System) and RMS (Room Monitoring System) have been automatically monitoring physical parameters of a room—such as temperature, humidity, pressure, and airborne particle count—for years, replacing manual readings in this regard. Increasingly, however, this trend toward digitization encompasses not only air parameters but also the management of a room’s operational status and access to it—exactly what used to be recorded on a paper card posted on the door.
In practice, this means replacing the card with a digital panel where the operator logs in securely—for example, using a contactless card or a code—and changes the room’s status with a few taps on the screen instead of manually entering information. The system automatically records who made the change, at what time, and what the previous status was, creating an audit trail that complies with the data integrity principles defined in FDA documents as ALCOA+, which include, among other things, the requirements that data be attributable to a specific person, legible, recorded in real time, and durable.
What does a company gain by implementing a digital status system?
The benefit that’s easiest to notice on a daily basis is time. Changing a status takes the operator just a few seconds instead of the several minutes it takes to fill out a form, and with many rooms and many changes per day, this difference adds up to actual working hours recovered for production. The second benefit—less visible on a day-to-day basis but crucial in the long run—is audit readiness. When every status change is automatically recorded with an immutable timestamp and operator ID, the quality department no longer has to manually reconstruct a room’s history. All it takes is to generate a report from the system, and the structure of that record corresponds exactly to what an inspector expects when verifying compliance with the requirements for electronic records and signatures.The third benefit is resilience to exceptional situations, such as a temporary network outage. A well-designed operator system continues to function locally during such an outage, and data synchronizes automatically once the connection is restored, so operations on the shop floor do not come to a halt due to an IT issue. We describe exactly such a system on our website—one that combines a simple operator panel at the room entrance with an automatic, immutable record of every change in the Audit Trail. There, you’ll also find information on how this system integrates with the consolidated view for the entire facility.
Summary
The cleanroom classification according to ISO 14644 addresses the question of how clean the air must be in a given environment. Answering the question of how that cleanroom is managed on a daily basis and whether its documentation will withstand an audit requires a different kind of system—one based on a digital, automatically generated record of every status change. The transition from paper forms to such a system is one of the most practical steps a facility can take today toward more reliable compliance and less time-consuming day-to-day operations.
Sources:
- Code of Federal Regulations, Title 21, Part 11 — Electronic Records;
- Electronic Signatures, eCFR.gov (FDA);
- FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application;
- Norma PN-EN ISO 14644-1:2016;
- Rozporządzenie Ministra Zdrowia z dnia 9 listopada 2015 r. w sprawie wymagań Dobrej Praktyki Wytwarzania, Załącznik nr 5, Aneks 1.
