The “as a service” (AAS) concept revolutionized the IT sector by making cutting-edge technology available to enterprises at a lower cost than would have otherwise been the case. The pharmaceutical business now benefits from this service-centered approach as expensive production techniques and infrastructure are made publicly available on demand.
Cleanrooms are essential for testing novel medications and therapeutic devices because they provide a regulated, contaminant-free environment. Their broad expansion has been delayed because a single dedicated cleanroom environment costs around $5000 to deliver and requires specialized expertise to maintain industry standards.
However, despite the fact that cleanrooms-on-demand offer a practical and affordable possibility for individuals working in pharmaceutical production, what are the main obstacles to adoption, and how can we expect the sector to overcome them to benefit from the opportunities available?
Meeting Strict Standards
The requirements that govern medical cleanrooms are stricter, with particular industry-specific criteria controlling their use, even though many production facilities across all verticals must maintain sanitary conditions for product integrity. There are certain cleanroom ISO standards that need to be adhered to.
The minimal criteria for a cleanroom suitable for manufacturing pharmaceuticals are outlined in the “ISO 14644” standards, which are graded from ISO 1 to ISO 9 depending on the quantity and size of airborne particles present.
With just two particles larger than 0.2 microns per cubic meter allowed at ISO 1’s cleanest standard, ISO 9 is the least restrictive level while still being much cleaner than normal production facilities.
Depending on the products and processes created inside the environment, multiple ISO standards are necessary. For initiatives like recreating habitats from other planets, the toughest ISO 1 standards, for instance, are applied in subjects like microbiology and physical sciences.
The majority of medical cleanrooms are ISO 7 or ISO 8 compliant. However, they could also need to adhere to other industry- or country-specific requirements, such as EU GMP guidelines A, B, C, and D. Pharmaceutical items are primarily Class C and Class D products, requiring an ISO 7 cleanroom (ISO 8).
It normally takes between one and five years to plan, construct, and open a qualifying facility because cleanroom conditions have such strict technical requirements. And even if the building is ready for its intended use, specialized people are needed to uphold compliance with stringent rules.
The difficulties hindering the broad development of facilities include the demands on time and financial resources.
Overcoming Industrial Obstacles
Pharmaceutical production is one of the sectors with the highest entry barriers, with high investment costs and rigorous regulatory procedures being the main impediments.
And the COVID-19 pandemic only made many of these problems worse, shining a light on how slow response times and a lack of available space made it difficult for the business to deal with and recover from pandemic-related problems
But as we continue to acclimate to post-pandemic normality, it is a chance to examine the procedures that still impede business advancement. Moving forward, the emphasis must be on promoting flexibility and agility to enable businesses to test, develop, and create goods quickly and at a fair cost.
The “build versus broker” argument, which contrasts the costs and potential of developing custom cleanroom facilities with the difficulties of outsourcing projects, is a crucial one in this goal. These specifically include the delays and hassles involved in working with a Contract Development and Manufacturing Company (CDMO) or a Contract Manufacturing Company (CMOs) to create new goods and sell them.
In order to overcome problems with economies of scale and efficiency, the new on-demand cleanroom model now provides the special advantages of both.
Cleanrooms-on-demand (COD) make it possible to produce smaller product runs that were previously impractical owing to the rigidity of scalable cost models. Pharmaceutical manufacturing frequently involves the testing and production of distinctive and tiny product batches, which makes the construction and upkeep of specialized cleanroom environments impossible. You only pay for what you really use with COD.
The difficulties brought on by CMO waiting lists and delays are also lessened by an industry-wide shift toward COD, which eventually eliminates capital expenditure, improves IP protection, gives producers more control over production schedules, and accelerates time to market.
The Trajectory Of COD
Although the COD market is still in its infancy, a lot of companies are leading the way as important adoption initial steps are being made in the sector. The popularity of COD services among these larger organizations, which have fewer resource constraints, only serves to highlight the market’s potential, which is expected to expand over the next five to ten years.
Additionally, the slow-but-steady growth of the COD market may really be a good thing, allowing major participants in the sector to get ready for any possible problems that could arise. Due to a lack of the specialized skills required to benefit from COD, these are likely the same difficulties plaguing the offering’s rivals, CMOs.
The on-demand model’s financial advantages give businesses the extra funds they need to solve internal shortages of specialized skills, allowing them to profit from COD in the future. This might entail including training financing in an employment agreement or just filling skills shortages with top-tier hires.
‘Modular cleanrooms,’ a temporary and adaptable product offering, will also contribute to the expansion of the COD market by allowing businesses to convert existing spaces into cleanrooms meeting industry standards, with dimensions and built-in features tailored to the specific needs of each project.
For instance, a new pharmaceutical company may collaborate with a COD supplier on a limited quantity of products, building a modular cleanroom environment with only 500 square feet, separated into two rooms – for product development and packing. To prevent contamination, each chamber is designed to give a certain atmosphere in accordance with special ISO criteria.
These services open up cleanroom manufacturing as a viable option for companies of various sizes and financial capabilities to support any project, allowing businesses to scale resources according to their requirements and budget.