People in LAF 4

Validation & compliance services

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:

  • Cleanrooms (GMP ANNEX 1 A B C D) (ISO 14644)
  • Isolation Rooms
  • LAF Cabinets (ISO 14644)
  • Biosafety Cabinets Type I, II en III (ISO 12469)
  • Fume cupboards
  • Operation Theatres

We take care of your GMP compliancy, over the complete life cycle of the cleanroom.

  • Coordinating and managing your qualification and validation projects
  • Preparing qualification and validation documents/master plans
  • Carrying out DQ/IQ/OQ/PQ for 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.

System engineering

Predict airflow dynamics with digital twins

Create a dynamic digital twin model of your cleanroom in order to engineer optimal airflow patterns and to optimize your cleanroom life cycle. A digital twin is a dynamic digital model of the cleanroom as product & process, which analyses existing business system data combined with real-world data.

Computational Fluid Dynamics

Comprehensive analysis of Computational Fluid Dynamics (CFD) predicts airflow dynamics, meaning that this dynamic digital twin model prevents less efficient airflow in your cleanroom. A dynamic simulation of our decentralized VIX air recirculation concept ensures an optimum airflow in your classified space. It optimizes the Air Change Effectiveness (ACE) index to achieve perfect air mixing of the entire cleanroom.

A digital twin allows us to simulate dynamic airflow patterns during night setback operations, but it also enables a reduction of the recovery time in a PAL by dynamically changing the Air Change Rate when entering the PAL.

Construction & quality management

Standardized building blocks for reliability

Modular & pre-engineered building blocks with a fixed structure will lead to approved high-quality cleanrooms as a result of its repeatable engineering process. The process is optimized and standardized, so errors are quickly detected and solved. Additionally, the delivery time of the product is minimized. Because the engineering phase shortens, time savings as well as cost savings are tremendous.

Engineers invest their time in a new design once, resulting in high-qualified modular products. This ‘Design for Reliability’ is a fundamental starting point for all cleanroom environments since every cleanroom must meet the requirements according to the function they are designed for. ABN Cleanroom Technology's quality system complies with "the Rules Governing Medicinal Products of the European Commission" and is subjected to both local and foreign inspections.

Our quality system includes:

  • Process validation
  • HVAC equipment validation
  • Cleaning validation
  • Training follow-up
  • Equipment calibration
  • Change control management
  • Deviation management
  • Regulatory affairs

Commissioning

Stakeholders are key

Our systematic commissioning process assures that your cleanroom performs in accordance with the design intent and the operational needs of the end-user. The results of our systematic approach ensure that stakeholder expectations are met. Commissioning verifies that what was specified was installed and that it functions properly. During commissioning, we primarily focus on satisfying engineering and stakeholder requirements. Understanding a cleanroom's failure behaviour is of the utmost importance for stakeholders in order to apply the right maintenance strategy.

ABN Cleanroom features

Expertise tandwiel

Expertise

Founded in 1996, ABN Cleanroom Technology has many years of experience in wide-ranging industries. Our R&D team and innovation driven culture help us stay ahead in pre-engineered & circular cleanroom design.

DBFM 2

DBFM

With a Design - Build - Finance - Maintenance approach, our services range way further than only building a cleanroom. Our OPEX finance model allows us to offer you a cleanroom-as-a-service all-in model.

Circular design approach

Circular design approach

In a focus shift from a linear 'take-make-dispose model' to a circular model, pre-engineered and modular concepts are the key to success. Circular thinking involves the reuse of materials, but also of data and knowledge.

Qualification

Solid project management

Our V-model approach according to EN15643 considers the Design Qualification, Installation Qualification and Operational Qualification of your cleanroom to ensure smooth production start-up. Solid project management according to this model does not only lead to efficient project execution but also to efficient cleanroom use without overlooking its demolition phase.

We assist you in creating qualification and validation plans, as well as qualification reports. Our well-trained and experienced engineering team ensures that the requirements are met. We are keenly aware of the responsibility that these plans and reports bring along. Following items are part of our qualification services:

  • FAT/SAT
  • Creating IQ/OQ documents
  • Executing IQ/OQ on-site and providing its documentation
  • On-site calibration (temperature, humidity and differential pressure)
  • Calibration protocols
  • Final qualification report
  • Technical documentation
  • Training and instruction

Validation

We are specialized in cleanroom validation for cGMP and ISO14644 compliant facilities. Our range of performance tests conform ISO14644-3 include:

  • Airflow volume measurements, air change rate calculations and airflow visualization
  • Air change effectiveness measurements
  • Unidirectional airflow velocity measurements
  • HEPA/ULPA filter integrity testing
  • Aerosol photometer method
  • Light-scattering airborne-particle counter (LSAPC) method
  • Non-viable airborne particulate monitoring
  • Recovery testing
  • Particle deposition testing
  • Temperature & humidity monitoring and uniformity mapping
  • Air tightness testing (RL 10 VCCN)

Our test reports provide following information and data: type of each measuring device used and its calibration status, the data collection technique, location of measurement points, occupancy state and the result of the measurement.

Maintenance & service

Industry 4.0 connected cleanrooms

Industry 4.0 connected cleanrooms enable a smart maintenance & service approach providing continuous insights in your cleanroom’s use and parameters in order to extend its end-of-life. Continuous connectivity with the cleanrooms makes it possible to collect data on the efficiency and use of the cleanroom and to act immediately when something threatens to happen. By doing this, we can optimise the life cycle of the cleanroom.

The current crisis is hightlighting the benefits and value of flexibility in the Industrial Internet of Things in the cleanroom environment more than ever. It is driving more people to investigate how the cloud and IIoT with software-connected cleanrooms and advanced analytics tools can turn data volumes into meaningful maintenance intelligence onsite or remotely accessible.

Design for maintainability with digital twins

Subsequent to a functional aspect with regard to air flow behaviour, a digital twin considers a life cycle aspect that has equally proven its value. A digital model of the cleanroom allows a verification of the cleanroom’s ease of maintenance and disassembly possibilities in advance.

Does the virtual digital twin show difficulties with regard to a cleanroom’s maintenance activities? Well, the ease of maintenance and repair starts at the design phase. Design adjustments can be made during our system engineering phase in order to avoid maintenance difficulties.

Request your cleanroom service

Multiple options can be selected

The modular way of thinking has been implemented by the design department of ABN from the start of the project. It is foreseen that the existing remodelled cleanroom will be further expanded in the future without having to carry out heavy work activities.

Caroline Spaas, Co-owner

ABN Cleanroom Technology is able to deliver a complete working cleanroom of high quality within a very short time frame. A real necessity to quickly meet the demands of our ever-growing customer base. Especially the fast approach from 'design to validation' is a big advantage. We are very satisfied with the services provided and hope to realise many more projects together with this company.

Rohnny Bamps, Facility Manager

Where to find our pre-engineered & modular cleanroom concepts?