Modular, bespoke, self-contained and scalable: Use PodTech™’s cleanrooms to make quality biopharmaceuticals accessible to all
Cleanrooms are an indispensable part of biopharmaceutical, medical device and other health product manufacturing. Their specialised design helps biopharma manufacturers and healthcare providers maintain controlled conditions within factories, laboratories and healthcare facilities.
Cleanrooms are not just rooms. They are an all-encompassing approach used to maintain certain environmental standards in settings where it matters the most. ISO Standards and good manufacturing practices (GMP) outlined by the US Food and Drug Administration (US FDA) and the European Union (EU) are globally accepted cleanroom guidelines. These standards detail specifications for every element associated with cleanrooms – room design and engineering, the materials of construction of the room and the equipment inside it, air handling systems and airflow, operations, personnel training and behaviour, the storage and handling of raw materials…
The list of cleanroom specifications is long and detailed, and every detail matters. This is because cleanrooms are meant to maintain product integrity during the biopharma manufacturing process. They also protect the operators and other personnel who work in the facility, prevent environmental contamination, and safeguard the health of communities who live and work around the facility. Essentially, cleanrooms are a matter of health and safety – matters on which the health sector cannot compromise.
The high demands made of cleanrooms typically translate to high costs, long timelines, operational rigidity and large manpower requirements. But they don’t have to.
PodTech™ was born with the vision to make quality healthcare accessible globally. We cannot do this without also revolutionizing cleanrooms – how they are constructed, how fast they are constructed, and how adaptable they are to an evolving scientific and epidemiological landscape.
Top-quality cleanrooms are a vital part of robust health sectors. They’re an important piece of the puzzle of global health equity. That’s why they’re front and centre in our portfolio of offerings.
Let’s explore all things cleanrooms: what they are, the details that go into meeting cleanroom standards, and how PodTech™’s cleanrooms overcome challenges related to cost, time and flexibility.
What are cleanrooms?
A cleanroom is a specially designed and constructed enclosed space. A highly controlled environment ensures that the space has low pollutant concentrations and meets the required environmental parameters. Temperature, humidity, pressure, particulate matter concentration, aerosol particle concentrations, the presence of airborne microbes… all of these aspects are highly regulated to safeguard product quality and safety. Acceptable particulate concentrations are usually expressed as number of particles per cubic metre at a specified particle size. For instance, the lowest standard of cleanroom construction, ISO 9, demands a level of no more than 35 x 106 particles/m3 for particles 0.5 microns or larger in diameter.
Regulating these parameters is far from easy. That is why cleanroom standards have guidelines for everything – from the quality of air filtration systems to the materials used to make equipment, from protective gear for personnel to operating procedures.
Biopharma manufacturers should have a comprehensive understanding of all relevant regulatory requirements for cleanrooms before they plan or construct one. A good grasp of the process is important as these stringent requirements will inform concept design, choice of equipment, waste disposal planning and other decisions – not considering these at the very start can result in budget overruns, delays and inconveniences later on in the project.
Design, engineering and equipment in cleanrooms
Incorporating cleanroom requirements begins at the concept design stage. The cleanroom itself – walls, ceiling, floor, door, windows and other parts of the room and building – must be designed to limit the ingress of unfiltered ambient air. The materials used to construct the cleanroom should not emit any airborne compounds or other contaminants. Surfaces should be smooth (so as to not trap pollutants) and easy to clean.
Typically, stainless steel or galvanized iron is used to construct the internal parts of the structure as well as equipment – non-corrosive materials work best since they reduce the chances of contamination. The mechanical strength of these metals is also a big advantage as it lends the cleanroom robustness and longevity.
In addition to regulating the construction and quality of equipment needed in the production process, biopharma manufacturers may also need to introduce additional machinery to maintain cleanroom integrity. For instance, de-dusting tunnels are becoming increasingly common in cleanroom designs. In this equipment, containers of raw materials are subjected to high-velocity air to capture loose and airborne particles, preventing dust and other contaminants from entering the cleanroom. Containment solutions like isolator technology – which provides a physical barrier between the work process and personnel – are also helping biopharma manufacturers maintain cleanliness and product integrity. This is particularly important to prevent cross-contamination with HPAPI (highly potent active pharmaceutical ingredients).
While safety and product integrity remain the priority, the trend in cleanroom design, engineering and equipment selection has been inching towards customisation, energy efficiency, sustainability and space-saving designs.
Air quality in cleanrooms
To meet safety and quality standards, cleanrooms must be supplied with air that is filtered through HEPA (high-efficiency particulate air) or ULPA (ultra-low particulate air) filters. This prevents particulate, chemical and biological pollutants from entering the controlled environment. We recommend that cleanrooms use filters rated for 0.3-micron particles, which means that the HEPA or ULPA filters trap particles that are 0.3 microns in diameter or larger.
The air supply to cleanrooms also generally employs laminar air flow principles. Mandated in ISO-1 through ISO-4 classified cleanrooms, laminar air flow maintains a constant unidirectional stream of filtered air with adequate downstream air returns.
Personnel in cleanrooms
Cleanroom personnel should be equipped with appropriate garments that prevent microorganisms, hair, skin flakes, clothing fibres and the like from contaminating the product. Personnel should also be well-trained in contamination control. Additionally, contamination control systems like air and mist showers are also useful in decontaminating workers on entry and exit.
Setting up high-quality cleanrooms globally to enable biopharmaceutical access
It is important to ensure safety and quality in cleanrooms but the stringent requirements in their establishment and operation mean that this is a challenging task – one that requires significant investment in terms of time, money and expertise.
Further, traditional cleanrooms also pose challenges in terms of scalability and future design changes. For instance, traditional cleanroom partitions make it difficult to alter floor plans in the future, when manufacturers may want to scale up production or introduce a modification to their process. Changing room sizes involves breaking floors, dismantling ceilings and other tedious tasks.
Modular or prefabricated cleanrooms address a lot of these challenges. Since the panels of a modular cleanroom are manufactured off-site and simply assembled at the factory or laboratory location, reconfiguring layouts is relatively simple.
Above, we’ve mentioned a few aspects of cleanroom design, construction and operation that must be considered. But there are a lot more to worry about – HVAC, lighting, plumbing, quality control… getting all of these in place and up to the desired standards is a complex endeavour. It is for this very reason that PodTech™’s portable modular cleanrooms come equipped with comprehensive systems integrated into the prefab structure. Each cleanroom is fully self-contained – it is “plug and play”, meaning that cleanrooms need only be connected to utilities on-site to become operational.
All of these benefits contribute to PodTech™ cleanrooms that are portable, bespoke, flexible, scalable, relatively quick to install, and more cost-effective than conventional cleanrooms. All of these benefits mean that cleanrooms can be deployed rapidly, with fairly small installation teams, in times of humanitarian crisis or health emergencies.
For any health sector player looking to set up cleanroom facilities, especially in resource-constrained regions, PodTech™’s modular cleanrooms offer unparalleled advantages. For anyone truly invested in health equity, these modular cleanrooms should be the go-to choice.