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Pharmaceutical Technology Europe
A modular cleanroom construction is typically a freestanding, solid and robust structure that is suitable for use within an existing cleanroom, laboratory, manufacturing area or warehouse.
A modular cleanroom construction is typically a freestanding, solid and robust structure that is suitable for use within an existing cleanroom, laboratory, manufacturing area or warehouse. A modular cleanroom uses off-the-shelf proprietary components that can be used to build a facility that meets the customer’s exact requirements, such as size, classification, lighting and hard or soft wall.
The demand for modular cleanrooms is increasing and more processes are benefiting from a cleanroom environment. However, cleanrooms can be expensive. With the recent years of cutbacks that many industries have felt, organisations have had to rethink their business strategies and become leaner in the way they manage processes. Modular cleanrooms are part of that leaner way of thinking. With traditional cleanrooms, retrospective modifications can be difficult and costly so future demands must be accounted for in the initial specification. Modular solutions are more flexible as expansions and relocations can be accommodated much more easily. Dramatic design improvements have also led to an increased demand for modular cleanrooms; for instance, the use solid, clear wall panels have improved perception. They are no longer seen as the temporary, low budget option and now offer a reliable alternative to traditional cleanrooms.
Modular cleanrooms are bespoke in nature. If you think back to the days when you may have played with Lego, you were building with bricks what, in effect, could have been off the shelf. You could build any shape and size of building, space rocket, car or whatever your imagination wanted whether large or small. Modular cleanrooms also use off-the-shelf proprietary components and when combined they create a customised cleanroom. A traditional cleanroom will typically require some form of alteration to a building, which in turn could involve planning permission (causing time delays and costs) whereas a modular cleanroom can be built within an existing area and made to fit.
One of the other principal advantages of a modular cleanroom is that it means a first step into a cleanroom environment does not necessarily have to be a costly exercise. You can buy a modular cleanroom to accommodate immediate needs and then expand it (as long as you have the space) as contracts grow and production develops. In cases of relocation, modular cleanroom can also easily be dismantled and then rebuilt and validated in new premises.
Small modular cleanrooms can be built and fully functional within 30 minutes (for example - 1.8 x 1.8 x 2.3m, 1 x fan filter unit to ISO Class 7) and larger modular cleanroom (for example 14 x 14 x 2.55, 35m x fan filter unit to ISO Class7) take about three days, which includes CAD drawing sign off, installation and validation.
Modular cleanrooms also offer benefits in airflow as they have a gap all the way around the bottom of the room, which ensures even airflow right and minimal turbulence. It also means there are no corners or areas where particles can be retained. The positive airflow prevents airborne particles from re-entering the room through the gap. This simple design element means that ventilation units are not necessary, which is a potential cost saving.
Looking at the drawbacks to modular cleanrooms, there is always the aesthetic element to consider. A modular cleanroom is generally delivered to site as a flat pack that needs to be built, so it has to be designed to be functional, transportable and easy to assemble. All too often, design aesthetics are not always a priority. Another potential aesthetic problem or annoyance with modular cleanrooms is unsightly cabling, as most walls are usually transparent. However, this can be overcome by housing the cabling in trunking, which requires a bit more advance planning and preparation.
The materials used to build a modular cleanroom can also be seen as a drawback. Some modular cleanroom structures are made from aluminium columns that may not always be as sturdy as those made of powder-coated steel.
The industry is becoming more aware of the advantages of a modular cleanroom and there is a greater understanding of the benefits you gain with a modular system. As such, fewer companies are opting for traditional cleanrooms, although this type of sterile environment is the preferred choice when a company wishes to create a showcase facility. Certain pharmaceutical procedures also require cleanrooms to be hermetically sealed, which is something that is hard to achieve with a modular cleanroom.
It is important to note that a modular cleanroom can attain the required ISO EN 14644-1 classification from Class 8 to Class 4. It is a common misconception that modular cleanrooms tend to be more suitable for the higher class of room, such as ISO Class 7 or 8. They can achieve lower particle counts and are frequently and successfully used by medical and research sectors where the products produced within the modular cleanroom environment are ingested or placed within the body via a medical procedure.
Another misconception is that only traditional rooms can be used for larger cleanroom requirements. Again, this is not always the case. Time and time again, modular cleanrooms have been designed and built to large-scale proportions without compromising particle counts. As long as the design, preparation and build are professionally executed the size of a modular cleanroom could potentially be any size that you require!
A modular cleanroom is, in effect, a room within a room. This does mean that there will be certain restrictions that the supplier will have to cater for in the design and build process; for instance, there will always have to be consideration for the shape of the room, such as ceiling height, fire exits and the flow of the building. These issues could be overcome with advanced preparation, such as site visits, drawing preparation and good customer communication. So, the challenges really are generally less than traditional rooms as there is no need to take into account planning regulations, which add time and money.
Single-use systems can be seen as a significant advance within cleanroom technology as they enable manufacturers to avoid in-house sterilisation and the recycling of existing equipment for reuse. As such, single-use systems can be seen as complementing the modular cleanroom by minimising health and safety risks and lowering the risk of cross contamination, which is a major factor for cleanroom validation.
To help combat the cross contamination of particles transferred by people when entering the cleanroom, change areas, stainless steel step over benches and correct apparel should be used. Whereas there is the environmental argument of single-use versus laundered garments, the latter option is potentially less environmentally friendly because it tends to involve the extensive transportation and packaging of a daily change of garments. However, it is up to the organisation to decide.
Overall, it is fair to say that single-use systems can complement the modular cleanrooms. By introducing a modular cleanroom into your organisation, you are offered a more flexible approach with the opportunity to increase or decrease the size of the cleanroom depending on the nature of your business. Single-use systems also offer flexibility to the modular cleanroom user through demands for quick batch changes, easier maintenance and reduced costs, along with a reduction in forms of cross contamination.