Cleanrooms-on-demand: a more efficient future for pharma?

The ‘as a service’ (AAS) model transformed the IT industry – making innovative technologies accessible to businesses without the high price point that would previously have been a barrier.

Now, this service-centred model is delivering advantages in the pharmaceutical industry, with costly manufacturing facilities and processes becoming widely available on an on-demand basis.

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. But with a single dedicated cleanroom environment costing around $2.5 million to deliver – as well as demanding specialist skills to maintain to industry standards – their widespread development has been slow.

However, with cleanrooms-on-demand representing a feasible and accessible opportunity for those across pharmaceutical manufacturing, what are the key challenges in adoption and how can we expect the industry to overcome them to reap the rewards on offer?

Meeting strict standards

While many production environments across all verticals must remain hygienic for product integrity, the standards that regulate pharmaceutical cleanrooms are more stringent – with unique industry-specific standards governing their use.

‘ISO 14644’ standards dictate the minimum requirements for a pharmaceutical-grade cleanroom – specifically, in the number of airborne particles permissible per volume of air – and are scaled from ISO 1 to ISO 9, based on the number of particles present and the size of these particles.

ISO 1 is the cleanest level – allowing just two particles 0.2 µm per cubic metre – with ISO 9 representing the least stringent measures, while still being significantly cleaner than typical manufacturing facilities.

Different ISO standards are required depending on the processes and products developed within the environment. For example, the strictest ISO 1 standards are used in fields such as microbiology and physical sciences – for projects like replicating environments found on other planets.

Most pharmaceutical cleanrooms are ISO 7 or ISO 8, but may be required to meet additional industry-specific or regional standards, such as EU GMP guidelines A, B, C, and D. Pharmaceutical products are typically Class C (requiring an ISO 7 cleanroom) and Class D (ISO 8).

Due to the rigorous technical specifications demanded of cleanroom environments, designing, building, and opening a qualifying facility typically takes between one and five years. And even once the facility is fit for purpose, specialised staff are required to maintain compliance with strict regulations.

The demands on finances and time resources are among the challenges preventing the widespread development of facilities. Enter cleanrooms-on-demand…

Solving industry challenges

Pharmaceutical manufacturing stands among the industries with the greatest barriers to entry, with the significant investment capital required and stringent approval processes among the key roadblocks.

And the COVID-19 pandemic simply exacerbated many of these challenges – with a spotlight focused on the lack of space and speed that hindered the industry as it looked to navigate and bounce back from pandemic-related challenges.

However, as we continue to adjust to post-pandemic normality, it marks an opportunity to review the processes that continue to limit industry progress. The focus going forward must be on facilitating flexibility and agility, to allow firms to test, develop, and produce products at speed and a reasonable cost model.

An important debate in this mission is the ‘build versus broker’ dilemma – comparing the costs and opportunities involved with building bespoke cleanroom facilities with the challenges involved with outsourcing projects. Namely, these include the backlogs and hassle associated with working with CDMOs or CMOs to develop new products and bring them to market.

Now, the emerging on-demand cleanroom model offers the unique benefits of both, combatting challenges in economies of scale and efficiency.

Cleanrooms-on-demand (COD) facilitate the development of smaller product runs previously unfeasible due to the lack of flexibility in scalable cost models. Pharmaceutical manufacturing regularly requires the testing and production of unique and small product batches that simply do not justify the building and maintenance of dedicated cleanroom environments. With COD, you only pay for what you need.

An industry-wide move towards COD also alleviates the challenges associated with CMO waiting lists and delays, ultimately eliminating capital expenditure, enhancing IP protection, providing greater control of production schedules, and increasing speed to market.

The future of COD

Although we are still in the infancy of the COD market, the industry is beginning to witness significant first steps towards adoption, with Azzur Group leading the way.

The pharmaceutical and life sciences services provider recently revealed its latest partnership with Moderna, collaborating for renting of COD services across the US. This marks a significant milestone, with Moderna claiming the partnership allows it to better manage the ‘timelines and the complexities of pharmaceutical manufacturing’.

The popularity of COD services among these larger corporations with fewer limitations in terms of resources only demonstrates the value to be found in the market, which will continue to grow over the next five to10 years.

And the steady pace at which the COD market is developing may be a blessing in disguise – allowing key industry players to prepare to mitigate the potential challenges that threaten to plague the market. These are likely to be the same challenges facing the offering’s competitors – CMOs – in a lack of the specialist skills needed to reap the rewards of COD.

The financial benefits of the on-demand model allow firms the additional resources to address specialist skills shortages within the business to reap the rewards of COD going forward. This may mean funding training as part of an employment contract or simply addressing skills gaps through hiring best-in-class.

The growth of the COD market will also be aided by the development of ‘modular cleanrooms’ – a temporary and flexible product offering that allows businesses to turn existing facilities into industry-standard cleanroom facilities in bespoke sizes and with integrated features to suit the exact requirements of each project.

For example, a new pharma firm may work with a COD provider on a small product run, developing a modular cleanroom environment at just 500 square feet, divided into two rooms – for product development and packaging. Each room is developed to deliver a specific environment to unique ISO standards to avoid contamination.

These offerings make cleanroom manufacturing an accessible opportunity for businesses of all sizes and resources to facilitate any project – with firms able to scale resources based on their needs and finances.

About the author

Jon Sewell is a Technical Manager at Origin Pharma Packaging, responsible for the Aseptic Filling Program and Special Projects. He has a wealth of experience, having worked in the pharma packaging industry for 17 years and overseen the design, construction, validation, and operation of multiple cleanroom suites.