How to choose the right modular clean room manufacturers for fast, scalable builds
When the Covid-19 pandemic hit, Pfizer and BioNTech decided, in March 2020, to work collaboratively on a vaccine. The partners chose two Pfizer facilities – one in Puurs, Belgium and another in Kalamazoo, Michigan, USA – to develop processes and manufacture their vaccine candidates at an industrial scale.
A formulation lab was built. An industrial process was designed. Existing spaces were repurposed. Pfizer’s locations on either side of the Atlantic positioned the partners well for global distribution.
Once clinical trials confirmed the efficacy of a vaccine candidate, manufacturing hit the ground running. Very soon, they had to ramp up production to meet surging global demand, and modular clean room manufacturers came to the rescue.
Intending to produce over 100 million doses a month, Pfizer added two new formulation suites at its Kalamazoo site. These weren’t just any formulation suites – they were 13,000 square feet worth of modular rooms shipped from Texas, equipped to dramatically cut the Covid-19 vaccine’s time to market.
In the words of Luc Van Steenwinkel, VP Pfizer Biotech Operations and Site Lead of Pfizer Puurs, “Adding flexibility and increasing volume has been key.”
Modular clean rooms as a mainstay of biopharma manufacturing
While endeavours like the race to manufacture Covid-19 vaccines and BioNTech’s “BioNTainer” project in Africa catapulted modular clean rooms to fame, the concept of modularity in the biopharma world has been around for a while.
Pfizer itself launched its PCMM concept – portable, continuous, miniature, and modular – for biopharma development and manufacturing way back in 2013. The company leveraged the support of pre-engineered clean room manufacturers to produce prefabricated PODs in Belgium and Texas, USA.
Each of these PODs comprised modular clean room panels put together to form modules, each of which was designed to execute one element in a continuous manufacturing line – think clean rooms, control systems, processing equipment, and the like. Shipped to and assembled at Pfizer’s Groton, Connecticut, USA, in 2015, the site was ready for operations within a couple of weeks.
From developing and launching an oncology product on the PCMM manufacturing platform, Pfizer estimates that over the next decade, seven out of 10 of its small-molecule, solid oral dose portfolio will be manufactured on PCMM. This will not only shorten cycle times but also accelerate technology transfers and reduce process variability.
Pfizer is not alone when it comes to its reliance on modular clean room manufacturers.
In 2018, Janssen set up a 38,000 square foot modular commercial‑scale biomanufacturing facility. It was delivered in nine months.
In 2020, Sanofi established a modular vaccine production facility in Neuville‑sur‑Saône, France, to produce multiple vaccines simultaneously.
Each of these projects was designed for a different purpose. They were based in different locations. They each had different pre-engineered clean room manufacturers. But they all enjoyed accelerated timelines, with as much as 30 to 50% time savings. They enjoyed the flexibility that comes with modular clean rooms. And they hold the potential for scaling up or down to meet demand.
Selecting the right pre-engineered clean room manufacturers
Each of these projects relied on different modular clean room manufacturers, the choice of whom would’ve depended on diverse factors – budget, location, offerings, and beyond. If you, too, want to set up a prefab biopharma facility using modular clean room systems, your choice of modular clean room manufacturers will also depend on your unique requirements, opportunities, and constraints.
One thing is certain – using modular clean room panels or systems is superior to traditional construction in terms of deployment speed, affordability, redeployment or relocatability, time-to-market, and even data collection. But that doesn’t mean that all pre-engineered clean room manufacturers are the same.
Modular clean room manufacturers vary in their experience and level of expertise. They vary in the designs they can execute and the requirements they can meet. Most importantly, modular clean room manufacturers also differ from one another in the level of support they can and are willing to provide.
Some modular clean room manufacturers may end their role on delivering the clean room systems to your site. Others will provide regulatory expertise. Some may offer support with procuring technology licenses. Others may give you end-to-end support with automation, engineering, project management, factory acceptance testing, site transfer, commissioning, qualification documentation, and even life cycle support for maintenance, filter replacement, monitoring system upgrades, and the like.
Selecting the right pre-engineered clean room manufacturer for you is easily the most important decision you will make. Making the right choice will impact not only the safety, quality and integrity of your processes but also the scale of the problems you can address, the time it takes you to get to market, and your longevity and sustainability in a competitive market. Choosing the right modular clean room manufacturer is the difference between a fast, scalable build and one that isn’t.
Modular clean room systems have increased in popularity in recent years, but that doesn’t mean you should hop aboard the trend without adequate caution. This includes choosing a modular clean room manufacturer who is sufficiently equipped to support you every step of the way.
From regulatory confusion to uncertainties about maintenance and redeployment, you will likely have questions as you step into this new realm of biopharma capability development. Make sure that the partner you choose can support you through them, setting you up for success in your research, manufacturing, or other operations.
That’s what we’ll be addressing in part two of this article.
Modular clean room systems are faster to set up and easier to scale than their traditionally constructed counterparts. This is because prefabrication lends itself to rapid deployment, customizability, and scalability.
In several ways, modular clean room systems are superior to stick-built ones. If you’re looking for a fast, scalable build, you should go the prefab, a.k.a. modular route. But all modular clean rooms are not the same. And neither are all modular clean room manufacturers.
In general, all modular clean room systems are manufactured off-site, at a factory, and then assembled on-site, at the client’s facility. But beyond this, there are many differences in terms of project scope, facility design, support in allied processes, and beyond.
Wondering how to choose a modular clean room manufacturer who can help you execute a fast, scalable build? Here’s what you should look out for.
What to think about when you think about modular clean room manufacturers
While selecting a pre-engineered clean room manufacturer, there are multiple elements to factor in – about not only the clean room systems they make but also the manufacturers themselves. Here’s a quick look at all the boxes you should check.
The more, the better: Integrations are key
The more self-contained a modular clean room is, the better.
When assessing a modular clean room manufacturer, examine their designs to understand the integrations they offer. The best, most efficient clean rooms are equipped with HVAC and air handling systems that use high-quality HEPA or ULPA filters, fire protection, building management systems (BMS), and electrical and process utility distribution.
More importantly, they should offer autonomous control over internal environmental factors like temperature, air pressure, humidity, and particle concentration levels – this enables the clean room system to operate with minimal human intervention while simultaneously meeting stringent cleanliness standards.
Such a modular clean room system, with all the essential components integrated into the prefabricated structure, must simply be connected to basic utilities and electricity to be ready for deployment. Called “plug and play” systems, they are among the best options for truly fast and scalable builds.
While opting for speed, you shouldn’t have to compromise on quality. Which is why in PodTech™’s prefabricated clean room systems, the utilities are of European origin while the Air Handling Unit (AHU) operates on advanced Japanese technology manufactured in the UAE. These integrations ensure that quality remains a priority in every project we execute.
Regulatory expertise ensures your facility remains compliant
Globally and in every region of the world, strict industry standards ensure that clean room systems maintain high levels of safety and efficiency. You must always pick a modular clean room supplier who demonstrates fluency in such regulatory standards. These include ISO 14644, USP 797/800, EU GMP Annexe 1, and FDA 21 CFR Parts 210/211.
Fluency with these standards is non-negotiable because they define the acceptable standards for every aspect of your clean room system, be it material flow, HVAC design, waste management, or air filtration. Your modular clean room manufacturer can only adhere to these standards and guide you through compliance audits, documentation, and validation protocols if they are well-versed in these standards.
End-to-end support ensures consistency and control
In your search for a modular clean room manufacturer, you should always give preference to manufacturers who offer end-to-end support in setting up your clean room system. Standard inclusions should typically include design, engineering, fabrication, automation, project management, factory acceptance testing, validation, site transfer, commissioning, and qualification documentation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Why is this important? There are several reasons. For starters, when manufacturers vertically integrate the above processes, they gain a level of control over the clean room system that is hard to achieve when multiple players are involved. Such control helps them ensure consistent quality across components. It makes project timelines and costs more predictable. It streamlines installation and speeds up the path to regulatory approval.
Technology support can enable processes you couldn’t have executed otherwise
Sometimes, a lack of technological know-how and skilled manpower can come in the way of producing essential products in your country or region. If this is a challenge that your facility is anticipating, it helps to partner up with a modular clean room manufacturer who can support you in procuring the necessary tech licenses or tech sharing agreements.
This is a common challenge, especially in LMICs. We address it by offering optional technology licenses and sharing options for fill and finish, inhalation suites, onco and novel products with established manufacturers from around the world. This enables even those countries that have been historically left behind to keep up with advancements in the pharmaceutical world.
Standardised systems reveal experience and expertise
When a modular clean room manufacturer offers standardised systems, it reveals that they are familiar with the requirements of such a system. If you’re looking for a fast and scalable modular build, such standardised systems are ideal.
For instance, we offer standardised systems for gene therapy, small-scale cell therapy, inoculation suites, contained filling areas, sampling and dispensing, patient recovery, 3D printing and drying areas, R&D, and diagnostics and testing labs. Our familiarity with these systems ensures that we can offer clients with these requirements a high-quality facility in record time.
Regardless, standardised systems do not mean that you have to let go of the customisations you require. Whether they offer standardised systems or not, your modular clean room manufacturer should be able to tailor their offerings to meet your specific production needs. The facility should be adaptable to changes, as needed, during production. And it should be flexible enough to be scaled up or scaled back when required.
You want a partner, not just a supplier
The best modular clean room manufacturers for fast and scalable builds are those who offer continuity through your manufacturing, research, and health service delivery operations.
This means that the ideal pre-engineered clean room manufacturer won’t end their collaboration with you at clean room delivery. Instead, they will be involved throughout the lifecycle of the modular clean room. From training, maintenance and system upgrades to spare parts provisions and responsiveness to regulatory changes, there are multiple aspects and processes in which they are willing to step up and support you.
In other words, the ideal modular clean room manufacturer is an ongoing partner in operational success, risk management, and quality assurance.
When you find a modular clean room manufacturer who ticks all these boxes, you can rest assured that you’ve found a partnership that will stand the test of time. Not only will this partnership help you execute a scalable build, but it will also ensure your sustainability in the long run.