Commissioning, Qualification and Validation
Quality Risk Management in Commissioning, Qualification and Validation
Commissioning, Qualification and Validation (CQV) are critical to the success of any cleanroom project.
At ABN Cleanroom Technology, we know that cleanroom projects succeed only with a clear and well-planned approach. Therefore, our process covers every project phase, from early process mapping to final validation and ongoing monitoring, ensuring all requirements meet industry standards.
Quality risk management (QRM) is a core part of our work. As a result, risks are reduced across the entire cleanroom lifecycle. Our commissioning, qualification and validation (CQV) team performs detailed risk analyses and defines mitigation measures to protect your operations. In addition, we ensure compliance with ISO 14644, cGMP, PIC/S, VCCN and Eudralex guidelines.
Faster CQV Through Configuration
The traditional Engineer-to-Order cleanroom model introduces project-specific design risks. These risks must be resolved during CQV, often causing delays. Our Configure-to-Order Plus (CTO+) solution shifts the focus from validating a one-off build to verifying a proven product. By configuring your facility from the ADAPTUS library of pre-engineered, validated modules, we:
- Minimize Risk: We start with systems that have already been tested and confirmed, simplifying the entire risk management process.
- Accelerate Timelines: We eliminate the lengthy documentation and testing often required for bespoke components.
- Guarantee Consistency: You receive a cleanroom solution with repeatable, predictable performance.
In scope for commissioning, qualification and validation:
- Cleanrooms (GMP ANNEX 1 – ISO 14644)
- Biosafety Cabinets Type I, II and III (ISO 12469)
- Operation theatres & isolation rooms
- Central Sterilization Areas
- LAF Cabinets (ISO 14644)
- Fume cupboards and fume hoods (ISO 14175-3)
- Process utilities & compressed gasses
- Validation of inert gases (UTILION™)
- Isolators
- GMP Monitoring System Validation (21 CFR Part 11)
Cleanroom Commissioning
After construction, commissioning ensures a smooth transition to qualification. First, we verify that all systems are installed correctly and operate as designed. In addition, we confirm that cleanroom performance meets defined specifications.
Because our commissioning process is structured and risk-based, it integrates seamlessly with qualification activities. As a result, commissioning is faster and supports timely project handover.
Cleanroom Qualification
To guarantee that your cleanroom and its systems meet the specifications detailed in the URS, we conduct a rigorous qualification process after the commissioning process. Our CQV team is trained for drafting, reviewing and executing all necessary qualification documentation, including protocols, test forms and reports tailored to your project.
Equipment qualification follows GxP guidelines such as GAMP 5, ISPE, and relevant ISO standards. The use of pre-tested and validated Configure-to-Order components reduces documentation effort and speeds up approval.
Guided by a clear qualification strategy defined in the validation master plan, we conduct:
Installation Qualification (IQ)
Verifies that your facility aligns with user and design requirements (as-built testing phase) in alignment with our standardized ADAPTUS configuration.
Operational Qualification (OQ)
Confirms that systems operate within defined limits at rest. Performance is consistent across our standard product range.
Performance Qualification (PQ)
Assesses your system performance under typical operational conditions (in-operation testing phase) delivering repeatable, predictable results due to the configured architecture.
Cleanroom Validation
Validation confirms that all instruments, processes, and activities consistently meet expected results. Our in-house CQV specialists perform all tests according to approved protocols to ensure reliable system performance.
Validation also covers sterility of processes, equipment, and utilities, including autoclave sterilization cycles. The CTO approach increases confidence in validation outcomes because we validate a configured system rather than a custom one-off design.
Our validation support covers everything from document review to specialized testing. We deliver a complete package that includes protocols, sampling plans, test results, detailed reports, and final conclusions. Our work aligns with key regulatory guidelines, including EU GMP Annex 15, FDA Process Validation guidance, and ICH Q9 Quality Risk Management.
Validation of inert gases (UTILION™)
In addition to cleanroom and equipment validation, we now provide comprehensive testing to verify gas purity and system performance according to applicable standards and process requirements. Our measurement capabilities include:
- Particle measurements in gases
- Microbiological / bacteriological monitoring
- Dew point measurement (moisture content)
- Hydrocarbon analysis
- ….
This new building block within the Validation department supports a fully integrated contamination control strategy, helping ensure reliable operation in industries such as pharmaceuticals, life sciences, and high-tech manufacturing.
Our testing
- Recovery testing
- Particle Deposition Testing
- Temperature & humidity monitoring & uniformity mapping
- Air tightness testing (RL 10 VCCN)
- Aerosol photometer method
- Air Change Effectiveness (ACE) measurements
- Unidirectional airflow velocity measurements
- Microbial sampling
- HEPA/ULPA filter integrity testing
- Light-scattering airborne-particle counter method (LSAPC)
- Non-viable airborne particle monitoring
- Microbiological sampling
- Airflow volume measurements, air change rate calculations and airflow visualization
- Validation of inert gases (UTILION™)
Monitoring
Our commitment goes beyond initial commissioning, qualification, and validation. Continuous monitoring is required to maintain the standards expected by regulatory authorities, including 21 CFR Part 11 for electronic records.
ICH Q7 highlights the need to regularly monitor and qualify utilities that can affect product quality. The FDA refers to ISO 14644 for defining cleanroom air purity limits. Both EMA and FDA stress the importance of maintaining air cleanliness, especially in the at-rest state. ISO 8573 defines compressed air quality requirements. These should be aligned with ISO 14644 cleanroom class limits to ensure consistent application.
By combining our patented VIX concept with the GMPConnect monitoring system, we support stable, compliant operation with built-in redundancy and efficiency. Our team provides ongoing support to keep your cleanroom compliant and operating reliably over time.
Our services
At ABN Cleanroom Technology, we provide cleanroom services that meet the highest standards. As a turnkey provider, we manage the entire process from design to installation and long-term support.
Moreover, our services include cGMP compliance, environmental monitoring, and full validation. Whether you’re launching a new facility or upgrading an existing one, we deliver tailored solutions that align with your goals.
Let's talk cleanrooms
Whether you’re looking for expert advice, a quick answer, or a detailed discussion, we’re here to help. Choose the option that works best for you: call us directly, send us an email, or book a 30-minute meeting at your convenience.
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info@abn-cleanroomtechnology.com
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