The ultimate guide to selecting the right cleanroom container
Regulated manufacturing is a common feature across many industries today. In biopharmaceuticals, medical devices, biotechnology and other healthcare-allied industries, manufacturing is regulated because of the severe risk to human health and lives in case of any contamination. In aerospace, defence, semiconductor manufacturing and other such industries, contamination control is necessary to ensure product integrity and precision in manufacturing.
Clean room containers are essential for effective contamination control.
Clean room containers – when designed, engineered and installed appropriately – support you in meeting your regulatory, operational, quality, financial, and business goals. Selecting the right cleanroom container is not a good-to-have; it is a must-have. It is a prerequisite to ensuring compliance with regional and industry standards. It is essential to protect the health and well-being of your customers. It is a critical step in ensuring product quality. And it is the means to ensure the growth of your business and maintain trust in your brand.
In other words, the construction and operation of your cleanroom container directly impact your audit readiness, your production timelines, your speed to market, and your success in the short and long term.
With the increasing pressures on manufacturers to scale, produce more, and produce faster, mobile clean room containers or portable clean rooms are gaining popularity and mainstream acceptance. But simply mobile is not enough – whether stick-built, modular or hybrid, clean room containers must be built with industry standards, business goals and sustainability in mind.
At PodTech™, our podules™ – turnkey mobile clean room containers – come in custom designs and self-contained units. No podule™ project is identical to the next because contexts vary – production goals, manufacturing processes, regional regulations, and contamination control requirements are invariably unique. Our experts take into account these unique circumstances to develop solutions that best serve our customers’ needs.
As you assess clean room containers for your manufacturing or healthcare delivery needs, these are some concepts you should be familiar with:
What are cleanrooms?
ISO cleanroom classifications.
Not all clean room containers are the same. Depending on their air cleanliness in terms of concentration of airborne particles, the International Organisation for Standardisation (ISO) separates them into classes ranging from ISO 1 (most stringent) to ISO 9 (least stringent).
Selecting the right class and meeting the appropriate clean room container standards (detailed under ISO 14644-1:2015) is critical to maintaining compliance with industry standards. Misclassification poses several risks – from product defects to regulatory penalties, from recalls to adverse impacts on your product’s consumers, there is just too much that can go wrong if you haven’t selected the right ISO class and the appropriate clean room container.
Below is an overview of the different ISO clean room container classes. Before you get started on your project, though, you must consult the official ISO 14644-1:2015 on cleanrooms and associated controlled environments or the latest version of the document at the time of your project.
ISO 1 to 3. These are ultra-clean environments necessary for semiconductor manufacturing and other industrial processes that require high precision levels. The strictly controlled particle levels prevent product defects.
ISO 4 and 5. Used in critical manufacturing, ISO 4 and ISO 5 clean room containers are appropriate for sterile pharmaceutical production and biotechnology applications.
ISO 6 to 8. These classes of clean room containers are general controlled environments used in food processing, medical device assembly, automotive, and other general manufacturing which require moderate contamination control.
ISO 9. The ISO 9 classification is for cleanroom-adjacent spaces. While these spaces resemble ambient air conditions, environmental quality is monitored to ensure compliance with clean room transition requirements.
These ISO standards offer a framework for the construction, operation and maintenance of clean room containers. Selecting a class to comply with depends on your industry, the sensitivity of your processes, your budget for operational costs, and your future production needs. Familiarising yourself with these classifications is key to selecting the right cleanroom container.
Industry standards for clean room containers.
The right clean room container for you will depend on the industry you are in, as the ISO classifications above suggest. This is because every industry (and even every product) has different manufacturing processes and regulations.
For instance, if you manufacture vaccines, your clean room container will have to meet not only ISO specifications as per the appropriate class but also the standards set by regulatory bodies like the FDA that oversees pharma manufacturing in the region of your operations and the FDA in markets where you sell.
Meanwhile, semiconductor and electronics manufacturing requires clean room containers to prevent dust collection and static electricity and protect delicate circuits from airborne particles.
Essentially, your industry will have specific operating procedures and regulatory requirements which you have to adhere to as you determine your cleanroom classification, design, and maintenance protocols.
Your URS.
Across industries, every project should have a URS, or user requirement specification. This document must outline what a system needs to enable it to achieve project goals. With all the expectations of the project outlined, a URS document, created early in any project schedule, serves as a roadmap for procurement and development.
When it comes to a regulated manufacturing project or any other application that requires cleanrooms, the URS should cover the nature of the operation, desired production scale, necessary equipment, personnel requirements, layout requirements, size, product flow, waste management systems, and every other detail that would affect the design and construction of the clean room container.
Without a detailed URS, a clean room container can’t meet all your regulatory and operational needs.
A URS for a clean room container, especially from a turnkey solutions provider, will include several details. From HVAC, lighting and energy efficiency to construction materials, waste management requirements and beyond, there is much to consider. Don’t worry – we won’t leave you hanging. The next part of this article will cover all you need to factor in as you select your ideal clean room container.
As you craft your URS for your cleanroom container, regardless of whether it’s a mobile clean room container or a stick-built one, you should think carefully about and include the following specifications to ensure that the clean room container you get meets your operational and regulatory requirements.
Construction and equipment materials.
The materials that make up the walls, ceilings, windows, furniture, equipment and other objects in your cleanroom container impact the presence of contaminants in your clean room environment.
For instance, some materials may shed fibres or emit volatile compounds into the environment. Meanwhile, some types of surfaces may attract and hold on to dust and other contaminants because of the texture or angle of the surface.
The ideal clean room container for your project will have walls and ceilings made of materials like HDPE, aluminium and/or FRP because they resist particle buildup and are smooth and easy to clean. The materials of your floor should also be smooth, non-porous and easy to clean – epoxy-coated flooring or vinyl usually works well. Meanwhile, doors and windows should be secure to prevent the entry of contaminants and maintain the required internal air pressure.
Depending on your industry, you may have to take into consideration additional factors. For example, a clean room container for electronics manufacturing should have non-static-producing surfaces.
Finally, the materials you choose for your cleanroom container must be compatible with the disinfecting methods and cleaning agents used in your industry. This may involve harsh chemicals and/or steam.
HVAC and airflow control.
HVAC stands for heating, ventilation and air conditioning. HVAC systems are used in all types of buildings to control the temperature, humidity and air quality indoors. In residential and commercial spaces, HVAC systems are used to ensure good indoor air quality and the comfort of occupants.
In a clean room container, however, HVAC systems have the additional responsibility of maintaining air quality in compliance with the specific ISO class, ensuring the predetermined airflow, and maintaining a positive airflow in the cleanroom to prevent the entry of contaminants.
HVAC systems also prevent the entry of contaminants into clean room containers by using high-quality air filters like HEPA and ULPA filters. High-efficiency particulate air (HEPA) filters prevent the entry of 99.99% of particles 0.3 microns in size or larger. Meanwhile, ultra-low penetration air (ULPA) filters work for particles 0.12 microns in size or larger.
Your choice of filtration level and direction of airflow, both controlled by your HVAC system, will depend on the industry you are in, the application of your cleanroom, and the ISO class you want to achieve.
You will also have to choose the type of airflow: low-turbulence airflow or turbulent mixing ventilation. The former is generally preferred, other than in cleanrooms with ISO 8 or 9 classification.
Sustainability.
Like many other biopharma operations, the use of clean room containers poses sustainability concerns. Specifically, operating and maintaining cleanrooms can be very energy-intensive because of the constant need for environmental regulation – think high-quality air filtration, temperature control, humidity control, etc. Additionally, in industries like biopharma manufacturing, cleanroom processes may also generate waste that can contaminate the environment.
To ensure compliance with ESG requirements, the right cleanroom container for you will have variable airflow systems – these change the airflow in the cleanroom container to adjust to the level of activity inside, minimising energy use during downtime. It will be built using recyclable materials. It will be illuminated with energy-efficient LED lighting. And it will incorporate waste management systems which suit your cleanroom processes.
Suitability for cleanroom protocols.
The cleanliness of a cleanroom is determined not only by its design and construction. It is also determined by its operations and maintenance, both of which must be carried out as per pre-determined protocols.
Depending on the ISO classification and industry, these protocols include personnel wearing gowning and personal protective equipment, regular cleaning and disinfection, material transfer and the direction of material flow, the use of airlocks to prevent a direct connection between the cleanroom and the outside environment, and more.
When you assess a clean room container design, you must make sure that the design allows for the effective implementation of these protocols.
Cleanroom construction models.
Regardless of your cleanroom container specifications and design, there are multiple ways in which it can be constructed.
Traditionally constructed or stick-built clean room containers are built on-site using conventional materials like drywall, steel framing, epoxy finishes, and integrated systems for plumbing, electricity, and the like. While such cleanrooms have proven their performance in the long term, compared to other construction models, they take the longest timelines, ranging from one to two years. Stick-built cleanrooms are also more expensive and subject to a greater risk of validation delays.
When prefabricated panels are used to build mobile clean room containers, pre-engineered wall, ceiling and door systems are manufactured off-site as separate panels. They are assembled on-site at the facility and are ideal for the addition of lighting, service chases, windows, and other such elements. These are ideal for internal buildouts in existing facilities as they cause limited disruption to active operations.
Modular portable clean rooms or container-based systems that we at PodTech™ specialise in are fully enclosed, self-contained cleanroom units that are built off-site at a factory. Most often, they come with integrated HVAC, environmental monitoring and controls, reducing your need to coordinate with multiple vendors. They may even be prevalidated. They simply need to be connected to utilities to become operational. Modular portable clean rooms are perfect for remote site installations, rapid deployment in times of emergency, and any other applications that call for economy and speed.
Finally, hybrid construction involves a combination of traditional building infrastructure, prefabricated panels, and/or portable clean room elements. While turnkey mobile cleanroom containers are usually the best option, hybrid is useful when production is planned in phased strategies, there is a transition between products made or platforms used in the cleanroom, or you need to scale up an already existing traditional cleanroom.
Selecting the right cleanroom container.
There is no single solution to everyone’s cleanroom requirements. While some traditional businesses may be comfortable with stick-built options, others may prefer turnkey mobile cleanroom containers.
In terms of operations and regulatory compliance, there may not be much difference between these options. But in terms of speed and cost of construction, installation labour requirements, validation speed, and ease of remote site installation, turnkey mobile cleanroom containers emerge as winners.
The time and cost investment into clean room container installation – whether for biopharmaceutical manufacturing, healthcare delivery or electronics manufacturing – is already a major obstacle to the development of essential industries. Portable clean rooms and turnkey mobile cleanroom containers offer a different, a better, a faster way to do it.
Let PodTech™ support you on this journey. Reach out today.