At the forefront of humanity’s interaction with the microscopic world—whether ensuring the sterility of every vaccine in Berlin or safeguarding the purity of every chip in Munich—we rely on two distinct yet equally crucial lines of defense. The first is the visible physical defense: the air barrier formed by HEPA /ULPA high-efficiency filters; the second is the invisible regulatory defense: theALCOA+ data integrity principles . One tangible, one intangible, together form the cornerstone of trust in modern high-end manufacturing.
What are ALCOA+ principles?
ALCOA+ originates from the field of Good Manufacturing Practices (GMP) for pharmaceuticals and is a set of internationally recognized guidelines for ensuring the integrity and reliability of electronic data. It is now widely used in all highly regulated industries.
Five Core Principles (ALCOA):
- A – Attributable: All data must be clearly traceable to its producer/creator (human or equipment) and the time of its creation. For example, a differential pressure alarm record must be traceable to which sensor triggered it and when.
- L – Legible: Data must be recorded persistently and legibly, remaining clear and unambiguous throughout the required retention period. Whether electronic or paper-based, records must not become blurred or lost over time.
- C – Contemporaneous: Data must be recorded simultaneously with the operation or observation. For example, a particle counter must record the event the instant it detects excessive particles, not as a post-shift entry.
- O – Original: First-hand records or verified copies must be preserved. This includes, for example, the original voltage/current signal values read directly from the sensor and an immutable chain of records converting them to engineering values(e.g., Pascals).
- A – Accurate: Data must accurately reflect the facts or observations. For example, differential pressure sensors must be periodically calibrated with traceable standards to ensure that readings accurately reflect the pressure difference across the filter.
HEPA/ULPA and ALCOA+ Principles: The relationship between the two is not conceptual but rather deeply embedded in the entire process of HEPA/ULPA system design, operation, and management.
1. Validation Phase: The “Birth Certificate” of Performance
The initial integrity test after filter installation (such as the IEST-RP-CC034 leak scan) is its performance “birth certificate.” ALCOA+ ensures this certificate is credible: scan data (such as the leakage rate at each point) must be recorded synchronously and original; the calibration status of the testing instruments must be traceable; and the generated reports must be clearly and completely archived for regulatory review years later.
2. Operation Phase: Continuous Monitoring of Health
Pressure differential and particle counts are monitored 24/7 through an online monitoring system. ALCOA+ is the “rule” for the monitor: Every data point automatically recorded by the system has an unalterable timestamp (synchronous and original).
Any parameter exceeding the limit (deviation) will be fully recorded by the system and trigger a traceable alarm handling process.
All sensors are calibrated according to plan, and calibration records are accurate and traceable, ensuring the accuracy of the data source.
Maintenance and Change Phase:
A Credible Record of the Cleanroom’s History When the filter differential pressure reaches its final resistance or it needs to be replaced as scheduled, the replacement operation itself generates a record. ALCOA+ endorses this “organ transplant” record: it records who, when, why, and which batch of filters was replaced (traceable and synchronized), how the old filters were disposed of, and how the validation data was performed after the new filters were installed (complete and consistent).
In the eyes of FDA or EMA auditors, a perfect cleanroom is not only about having the highest-grade ULPA filters, but also about being able to present an impeccable chain of electronic evidence conforming to ALCOA+ principles to prove that this clean environment has been under control every single day and every second. Therefore,Trenntech believes that in modern high-end manufacturing, HEPA/ULPA provides “physical protection,” while the ALCOA+ principles construct a “legal evidence system” around this protection. Both are indispensable, jointly safeguarding the ultimate bottom line of product quality and safety.