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

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

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

V-model according to EN15643:

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 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.

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.

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

Questions about our pre-engineered cleanroom thinking?

We’re happy to talk cleanrooms, the benefits of pre-engineered cleanroom design, and can help you get started with your concept or project. Simply contact us. We’ve helped companies as small as startups to the global pharma companies figure out the best fit for their production process. We can help you too.

Want to do some research on your own?

Blog
18/12/2019

Why modular cleanrooms are the future

Modular cleanrooms offer an innovative alternative to conventional cleanrooms for spaces that require a certain flexibility in terms of future needs or restricted build timeline. Modularity is the starting point to help companies to enable cleanroom technology with ‘modular’ meaning scalable, flexible & agile.
Whitepaper
15/01/2020

Darwin would favor modular cleanroom design

Today’s cleanroom concepts are evolving towards a modular design approach in order to meet rapidly changing needs in cleanroom technology business. Cleanroom concepts that adapt easily to these changing needs will keep evolving. If your business requires a classified space, we hold on to modularity.
Whitepaper
03/12/2019

5 forces that drive energy efficiency in modular cleanroom design

Cleanrooms consume large amounts of energy compared with the energy consumption in non-classified rooms. By understanding those determining factors that lead to high energy usage, we brought together 5 aspects that help you drive reduced energy consumption and lower the energy footprint in modular pre-engineered cleanroom design.