There are varying levels of cleanliness that need to be taken into account depending on the use of each space within a biotech facility. While cleanrooms face the most scrutiny, all areas of a biotech facility should encourage cleanliness, including the staff washrooms, the administration areas, the warehouse space, etc. The design principles used to achieve cleanliness in a biotech facility can be lifted and applied to other commercial settings.
Some of a facility’s cleanability is driven by how the space is designed. Here is some of the regulatory guidance an architect must take into account:
Per Eudralex: “To reduce accumulation of dust and to facilitate cleaning there should be no uncleanable recesses and a minimum of projecting ledges, shelves, cupboards and equipment.”
Per CFR-21: “All rooms and work areas where products are manufactured or stored shall be kept orderly, clean, and free of dirt, dust, vermin and objects not required for manufacturing.”
Adhering to these regulations translates into crack and crevice-free construction. It requires elimination of any areas promoting stagnation or particle build-up. Any surfaces that will attract or collect particles need to be kept to an absolute minimum or gotten rid of entirely. On a practical level, this means minimizing the amount of surfaces available to touch in a cleanroom. All surfaces need to be easily cleanable and therefore free of ledges where debris can collect—including window sills. All walls are constructed to be flush surfaces up-and-down with no sills or ledges.
There is no room for dust bunnies within a biotech facility. This is why they are designed with very squared off rooms with no extra nooks or crannies whatsoever. In high classification rooms, this is taken to the next level by replacing 90 degree corners with rounded inserts, therefore widening the radius of the crevice so that it can be cleaned more easily.
Additionally, airflow returns are placed at floor level instead of at the ceiling. This downward airflow pattern drives particulates and contaminants down to the floor, reducing the amount of air-borne or suspended contaminants. The airflow then sweeps particulates across the floor towards one of these floor level low wall returns. Sometimes these low wall returns even feature filters to prevent contaminants from re-circulating in the HVAC system.
Other commercial spaces can apply these principles by minimizing places where dust and dirt can build up. While only new designs can implement permanent features like flushed wall construction, all commercial facilities can encourage an elimination of clutter and superfluous furniture, including extra fabric seating, wall shelves or decorations. Office staff should be encouraged to keep personal items to a minimum so that desks and other surfaces can be cleaned easily.
Biotech facilities are again challenged to meet specific regulatory guidance regarding what kinds of materials can be used within their facilities, especially within designated clean areas.
Per Eudralex: “In clean areas, all exposed surfaces should be smooth, impervious, and unbroken in order to minimize the shedding or accumulation of particles or micro-organisms and to permit the repeated application of cleaning agents, and disinfectants where used.”
As stated in the above regulatory guidance, one of main reasons that construction materials must be hard-wearing is to withstand cleaning from rigorous daily cleaning regimes. Corrosive cleaning agents such as Spor-Klenz and bleach are often used in the surface wipe-down process. Viral-containing facilities are often decontaminated by fogging, which means introducing and circulating a cloud of vaporized hydrogen peroxide (VHP) which kills viruses, bacteria, and pretty much all living things on contact. Materials must be specifically selected to withstand repeated contact with VHP.
Materials that are suitable for use in biotech manufacturing facilities include epoxy floors, epoxy-painted walls, glass and stainless steel. No carpeting can be used due to possible dust particles and no wood is allowed, as it carries potential for bio-burden.
Other commercial facilities can take a cue from biotech facilities by selecting hard-wearing materials that can stand up to increased cleaning procedures and are resistant to chipping, flaking, oxidizing, or other deterioration that could foster a dusty environment. Where possible, woven textiles should be replaced with wipeable vinyls and window coverings should be washable.
The installation of touchless sensors is a great way to reduce cleaning workload and cross-contamination. Some biotech facilities leverage technology like touchless sensors on toilets, urinals, and sinks, as well as motion-activated motorized doors to reduce touch. Many of these are already common in non-cGMP facilities, but we suspect that we will see a push for even more integration of touchless sensors within all types of commercial design projects.
The main takeaways from an examination of cleanability within a biotech facility are the need for clean design, good material selection, and the implementation of touchless sensors in common areas. Of course, there is an ongoing balance between public safety and cost. There is only so much money available to build any facility. Even within a biotech facility, not all surfaces outside of the manufacturing core are wipe-down friendly. Other commercial facilities can similarly look at which areas are the most high-risk and concentrate their efforts on increasing ease of cleanability in those areas.