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At the core of industries such as pharmaceuticals, biotechnology and microelectronics lies a critical requirement: contamination control. Cleanrooms provide the controlled environments necessary to meet the most stringent cleanliness standards. But ensuring that these environments consistently meet the required specifications is only possible through rigorous cleanroom validation and data monitoring.
Cleanroom, equipment & software validation is the structured process of confirming that a cleanroom and its assets perform consistently within the specified parameters necessary to maintain controlled conditions. For ABN Cleanroom Technology’s trained validation team, this involves testing environmental factors such as air quality, filtration efficiency, airflow patterns etc. Validation ensures compliance with international standards such as ISO 14644 and Good Manufacturing Practice (GMP) guidelines, making it essential for industries where even the slightest contamination can result in compromised product quality or safety.
Our validation process typically includes several stages:
To ensure that cleanroom performance meets customer requirements, our validation process focuses on several critical parameters, such as:
While cleanroom validation verifies that operational standards are met, data integrity ensures that the information collected during validation and regular operations remains accurate, complete and consistent. In cleanroom environments, where precision is non-negotiable, maintaining data integrity is critical for compliance, traceability and decision-making.
GMP Connect, our platform for data integrity, focuses on ensuring that all records—whether they are measurements of air quality, particle counts, or temperature and humidity levels—are recorded accurately and cannot be tampered with or altered without authorization. This is crucial in highly regulated industries like pharmaceuticals, where compromised data could lead to significant operational setbacks, regulatory penalties and even patient harm.
At ABN Cleanroom Technology, data integrity and cleanroom validation go hand in hand. The validation process generates extensive data, from airflow readings to particle counts, all of which need to be documented and stored securely for auditing and compliance purposes. With GMP Connect, we offer a validated software environment for GMP-critical manufacturing areas.
Key aspects of data integrity with GMP Connect in cleanroom validation include:
The demands on cleanroom environments continue to evolve, particularly with the implementation of regulatory frameworks like GMP Annex 1. As such, continuous validation and data monitoring is essential for keeping cleanroom facilities up to date with evolving standards and technologies.
At ABN Cleanroom Technology, our in-house validation team plays a crucial role in ensuring your cleanroom, equipment & software meets all necessary regulatory and operational standards. With a deep understanding of the complex validation process, our experts manage every aspect of cleanroom qualification—from initial design qualification to ongoing performance checks. This includes documenting each stage with the thoroughness required to provide full traceability and compliance proof for national and international regulations such as ISO 14644 and GMP guidelines.
By maintaining an in-house validation team, we guarantee:
Legolisation means standardisation. Standardisation causes a shift in production. Work is carried out in conditioned spaces such as factory halls. our cleanrooms are manufactured partly or entirely off-site, which means huge savings on transport costs and reduction of inconvenience on-site