Modular facilities are prefabricated buildings that are built using multiple sections, often known as modules. Modular constructs used in such facilities are designed, engineered and manufactured off-site, and later delivered to the intended site of use for final installation. In order to ensure that all critical systems are precisely configured, compliant to existing guidelines and fully operational, the modules are tested before shipping.
In recent years, the concept of using modular manufacturing facilities in the pharmaceutical industry has witnessed renewed interest from several industry players. This can be attributed to the increasing demand for improved processes and production facilities that are capable of handling multiple product types. In addition, the shift towards manufacturing of smaller batches of drugs, in case of personalized therapies or candidates targeting rare diseases, are some of the key driving forces for the growing popularity of modular manufacturing plants in the pharmaceutical industry. The adoption of modular facilities is growing in the pharmaceutical industry and the modular construction market is anticipated to grow at a CAGR of 10% during the forecast period.
It is worth mentioning that in September 2021, Pharmamodule successfully delivered China’s first modular mRNA coronavirus vaccine facility to Walvax. The modules of this facility were constructed and delivered in less than half the time usually taken for traditional projects, thereby, accelerating the vaccine production in China. Further, Exyte is constructing a mRNA competence center at the Halle Biotech site of Wacker Chemie. The facility is expected to cover an area of 7,400 sq mt, of which, 1,600 sq mt will be clean rooms. The plant is intended to manufacture mRNA utilized for the production of coronavirus vaccines.
Modular Construction Process
The modular construction process is believed to reduce the overall time by 50%, as many of the processes are conducted simultaneously. Although the initial planning required to ensure that all modular units fit together properly is complex, the overall modular construction strategy is simple. The modular construction process, is divided into the following steps:
- Plant Fabrication: The modular units are constructed as per the approved design by the modular building manufacturer. Each modular unit is constructed in a safe and efficient weather protected offsite assembly plant. A third-party inspection agency is usually present to ensure the modules are built in compliance with building codes.
- Transportation: The type and size of the project determines the mode of transportation used. For large projects consisting of dozens of modules, transportation is staged in phases so that installation of modules can be done in the proper sequence. Generally, fabricated modules are transported from the manufacturing facility to the site of installation by carriers (trucks or ships) that are specially designed to tow them.
- Installation: Once the modules arrive at the installation site, they are staged to be set on the completed foundation system. The installation of a modular building is determined by the choice of building foundation. Cranes are used to set modular units on permanent, semi-permanent and on grade foundations. Raised foundations, commonly used for temporary buildings, allow the modules to be set in place through simple mechanical methods. The individual modular units are methodically placed on the foundation one at a time and next to each other to align them properly.
- Final Finishing: After the modules are assembled, the final finishing of the interiors and exteriors begins. During fabrication, the walls, ceilings, electrical systems, plumbing and heating, ventilation, and air conditioning (HVAC) systems are installed so that they line up correctly with the modules. In addition, each joint between the modules (known as mate line) are connected. The modular units are seamed by addition of exterior facade and weather proofing material at the mate lines, interior floor and wall finishes. Once the installation is complete, external connections are made with utilities, sewer, alarm systems and data lines, as applicable.
Various advantages of modular plants in the pharmaceutical industry are discussed below:
- Reduction in Construction Cost: Typically, modular construction can reduce 25-30% of the overall construction costs. It generally requires a modest up-front capital investment. This is due to the fact that prefabricated components can be installed quickly and easily, as well as require lower labor costs. Modular construction also provides cost savings in construction and design as there is no need for consulting an independent architect or engineering firm, in most of the cases.
- Minimal Plant Site Interruption: With modular construction approach, there is minimal interruption in the existing operational unit(s) at a particular site, as 80% of the construction work is carried out offsite. This prevents any potential hazards, production interruptions and safety risks, which are usually associated with field construction activities.
- Faster Construction: Offsite construction of the facility, site preparation and procurement of necessary permits proceed simultaneously, which can potentially shorten the overall construction timeline. It is estimated that a modular facility for biologics, oral solid dose, or aseptic filling can be built in only 12 months (from project start to operational qualification), while a traditional facility can take three to seven years to complete. A shell building or modular cleanroom can be erected in six to eight weeks; the cleanroom pods are built parallel to the shell building and require 15 to 18 additional weeks.
- Portability: Modular facilities are portable and can be transported anywhere due to their ability to be disassembled into smaller subsystems. This attribute can be particularly beneficial in case of an outbreak of a disease, where rapid production of drugs in emergency situations is the major concern. Therefore, a pandemic-ready modular facility could be a good option in the future when dealing with the proliferation of tropical diseases and regional outbreaks, such as the recent COVID-19 pandemic.
- Benefit to Emerging Markets: Emerging regions lack proper infrastructure and struggle with GMP related issues due to the unavailability of local construction expertise and materials. Moreover, speed-to-market is crucial in such markets as the success of a drug relies on its quick transition to market. Modular construction enables the use of facilities fabricated in the developed markets to be easily transported and assembled in emerging geographies. This ensures that manufacturing of products in emerging markets occurs under similar conditions as in developed markets and addresses GMP related issues faced in such regions. Additionally, these facilities can be constructed and made operational quickly.
- Flexibility and Future Expansion: Modular construction involves the combination of standard components in multiple ways that make them flexible and scalable. The capacity of a modular structure can be increased by merely plugging in new modules. It also has the potential for reuse by removing and relocating existing modules.
- Safe Working Conditions: Modular facility sub-assemblies are created in a controlled environment factory setting, hence, there are less risks associated with environmental hazards, weather conditions and contaminants. Additionally, there is relatively less risk of accidents and other liabilities, in comparison to conventional job sites, thereby, ensuring safety of employees.
- Sustainability: Traditional construction and maintenance methods give rise to large amounts of waste material going into landfills. Moreover, buildings are one of the major sources of climate pollution, contributing to 39% of the global emissions. On the other hand, prefabricated assemblies consume comparably less resources and can help achieve a project’s sustainable goals.
In addition to the above-mentioned advantages, other benefits of modular construction include higher cost predictability for each module, shorter time to market, less wastage, potential to standardize operations, reduction in required manufacturing area, HVAC requirements, and chilled water and steam demands associated with cleaning. It has also been demonstrated that a modular facility reduces energy consumption by approximately 15%.
Challenges and Future Prospects
It is evident that shifting from conventional on-site construction to off-site modular construction can fundamentally avoid unforeseeable risks. However, on the other hand, construction of modular facilities may face certain challenges, in order to maintain the essentials of design and equipment of the facility. Some of these challenges are associated with logistics constraints, transportation, safety permits and communication barriers. In addition, lack of coordination between client and service provider, and inadequate interconnectivity between modules and field conditions may also create hurdles in the entire process. Such challenges can be easily overcome by recruiting effective measures, including properly planned installation sequence, efficient virtual resources, close coordination between involved stakeholders. It is worth mentioning that, complying with user acceptance tests, such as Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) prior to installation and delivery of project serve as a crucial step in order to resolve issues in a timely manner.
It is quite perceptible that the biopharmaceutical industry has been rapidly evolving and this evolution in the biopharmaceutical value chain is likely to impact the future facility decisions. This rapid progression has generated a need for a facility with efficient large scale production capacity. In fact, with the new changes in drug development system and accelerated regulatory approvals, regulatory authorities will require local outlets to fast-track new molecules and eventually giving shorter time to market. Modular construction is an ideal solution to meet their needs in minimal time. For instance, in January 2022, Germfree launched its bioGO cGMP Mobile Cleanroom in order to deal with the challenges faced in the development, manufacturing and delivery of novel and soaring curative therapies.
Further, it is worth mentioning that the COVID-19 pandemic had a considerable impact on the drug manufacturers. The drastic increase in demand for manufacturing vaccines prompted the companies to seek out for additional production platforms in existing plants. Under such circumstances, it becomes necessary for biologics manufacturers, both contract manufacturers and biopharmaceutical companies to adopt versatility and adaptation, in order to expand their capabilities to keep up with the growing demands. Modular designs can provide sufficient flexibility to meet such demands. Additionally, the standardization of modular platforms allows operational availability at different site locations and help maintain an optimized process flow. It is noteworthy that if these mobile autonomous structures have incorporated containment, segregation and repurpose design aspects, these units can be used for vast number of other applications and moved to different locations if needed. Driven by the rising interest of stakeholders towards improvement of manufacturing and production efficiency, the anticipated lucrative opportunities and growth associated with the adoption of modular facilities, the modular manufacturing market for pharmaceutical industry is expected to witness noteworthy market growth during the forecast period.
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