Depending on whether we’ve been appointed by a pharmaceutical manufacturer or a principal contractor, our clients have different expectations when it comes to cleanroom design. End users expect to see plans and elevation drawings to help them visualise a facility and satisfy that each element is present and positioned correctly. If the end-user has appointed a principal contractor that lives in the design and construction world, expectations are much higher.
No matter what the expectations are, each client needs the same level of service—one that delivers compliance to regulations and successful interfaces between the new cleanroom and its surrounding facility.
Whilst 2D and 3D models are beneficial to allow clients to visualise their project and conduct virtual reality walk-through tours to test the layout and workflow, there’s now so much more that can be done with the help of digital modelling.
The UK has mandated compliance with BIM level 2 for any public sector project
Cleanrooms are complex systems that require a combination of a hygienic envelope and HVAC system design to create a controlled environment appropriate for processes. To make sure that cleanrooms are fit for purpose, C2C’s team of Autodesk-certified design engineers carry out designs following the latest Building Information Modelling (BIM) standards and workflows. In 2016, the UK Government mandated compliance with BIM level 2 for any public sector construction project and since then this standard has become the default. Working to an agreed standard allows full collaboration and coordination with any other contractors involved in a facility build, resulting in greater accuracy and higher quality results.
Design time
Say, for example, as part of a new facility fit out you have a cleanroom specialist appointed to build a cleanroom and a construction company building a mezzanine. Both companies can amalgamate their BIM models—or import one into the other—to create a federated model. Clash detection can be performed on this federated model to create accurate interfaces between the two elements of the fit-out. Not only does this improve accuracy, but it also shortens overall project timelines as it reduces finish-to-start dependencies. In this example, when working with a federated model, the installation of the mezzanine doesn’t need to be complete before the design of the cleanroom can start.
Some cleanrooms are installed into large warehouses with little or no interfaces with the surrounding environment. But some cleanrooms need to be installed into areas where space is at a premium. These cleanrooms may need to incorporate HVAC ducting into tight ceiling voids or align windows and doors with existing openings.
With a federated model, installation of the mezzanine isn’t needed before design starts
Point cloud surveys can 3D scan the current environment of facilities to create an exact digital model. A proposed cleanroom design can then be imported into the 3D scan to clash detect and verify that the design operates in line with the planned process and its surrounding environment. With this advanced level of planning and design, prefabrication of certain components of a build can be made off-site to avoid working within restricted spaces when on-site.
When working to BIM level 2 everything you draw isn’t just a representation of an independent system, it’s a live model with information that sits alongside it. When these models get client approval, the data on the parts required for the build can be automatically fed to procurement teams to source.
These Design for Manufacture and Design for Assembly (DfMA) principles mean there is no need to manually create a bill of materials. Instead, exporting data from the design package straight to the Enterprise Resource Planning (ERP) software is a one-step process. This automation reduces the chance of human error and provides a reduction in the processing time of around 80%.
Airflow modelling allows you to analyse the airflow and all the contributing factors
The enhanced data provided in a BIM model means that as well as providing an Operations and Maintenance manual in the client handover, you can also provide a live model of the facility. Why would we do this? The answer is risk analysis. These BIM models can be used to track failures and any required maintenance. Data is then fed back into a database so decisions can be made by facilities managers on maintenance schedules.
Another type of modelling that is incredibly beneficial for cleanrooms is airflow mapping. Furniture layout, temperature and humidity, and heat gains from equipment can all have a big impact on the way air moves through a cleanroom.
Airflow modelling allows you to analyse the airflow and all the contributing factors that affect it, to see how particulate is moving. You can even isolate different particle sizes, depending on which sizes are of concern to the process. Visualising how clean the air is at the critical point of a process allows you to optimise the airflow path. Better airflow patterns can be achieved by positioning the air supply immediately above critical parts of the process and the strategic positioning of air return grilles.
Of course, many manufacturers will need to be compliant, not only with ISO 14644-1, but also GMP Guidelines. When working towards GMP compliance, there needs to be a documented Design Qualification (DQ) process. DQ verifies that the proposed design of the facilities, systems, and equipment, is suitable for the intended purpose. It starts right from the conceptual design phase of the project. Digital modelling helps to qualify that the performance of a cleanroom is in accordance with the parameters stipulated in the User Requirement Specification (URS). This approach mitigates the risk of non-compliance with a URS and avoids delays and modification costs at later stages of the project.
