Cleanrooms are classified on a particle count basis based on standards, the most common of which are ISO 14644-1 and GMP classes as described in Eudralex Volume 4 Annex 1.
ABN Cleanroom Technology manages ISO and GMP cleanrooms throughout their lifecycle, from preparing qualification and validation documents to conducting DQ/IQ/OQ/PQ processes for all cleanroom areas. Upon completion, an ABN Cleanroom validation engineer conducts a final inspection, and a comprehensive end report is provided to the commissioning party, inclusive of recommendations for addressing any comments or deviations. Our measurements utilize highly accurate, calibrated devices, and our procedures consistently adhere to current standards.
Validation of utilities and processes plays a pivotal role not only in ensuring the safety and efficacy of medicinal products but also in regulatory compliance, cost reduction and enhancement of manufacturing process robustness and efficiency.
In a cleanroom environment, various compressed gases may need validation depending on the specific requirements of the facility and processes involved. Validation of compressed gases typically involves ensuring their purity, quality, and compliance with relevant standards and regulations. Some of the common compressed gases that we can validate are:
Software System Validation entails the creation of comprehensive documentation to offer a high level of confidence that a particular process will reliably generate products meeting predefined specifications and quality standards. Mandated by regulations such as 21 CFR Part 11, Annex 11, ICH E6 (R2), among others, Computer System Validation is essential for key GxP processes. It affords oversight and control over computerized systems utilized in GxP processes, ensuring compliance and insight into their functionality.
With GMPConnect, we offer a validated software environment for GMP-critical manufacturing areas. This cloud-based application is suitable for real-time monitoring and alarming of temperature, humidity and other parameters.
Do you want to receive more information about how pre-engineered building blocks and circular cleanroom design will benefit your project? Simply send over a request. You can also contact us with questions about our services, ranging from cleanroom validation and GMP-monitoring, to commissioning and cleanroom remodeling.
We take care of your ISO and GMP cleanrooms throughout its entire life cycle. After we have started with coordinating and managing your qualification & validation projects, we prepare all of the qualification and validation documents/master plans. On top of that, we carry out a DQ/IQ/OQ/PQ for all of the media, HVAC and process equipment. Once the measurements have been completed, a final check will take place by the ABN Cleanroom Validation engineer. A detailed end report will be handed over to the person in charge of the commissioning party. This measurement report also contains recommendations on how to deal with any comments or deviations.
All our measurements are taken using the most accurate, calibrated measuring devices and our procedures are always in accordance with the current standards. ABN Cleanroom Technology has the experience and knowledge to support you in testing and validation of:
Check out the various services we offer to keep the performance of your cleanroom optimal at all times.
Do you want to receive more information about how pre-engineered building blocks and circular cleanroom design will benefit your project? Simply send over a request. You can also contact us with questions about our services, ranging from cleanroom validation and GMP-monitoring, to commissioning and cleanroom remodeling.
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
