By Jerry Martin
Growing manufacturing styles offer long-term benefits in overall costs, production flexibility, and sustainability.
Imagine if creating a pharmaceutical manufacturing facility were as simple as putting together a LEGO kit. While this level of ease and speed may never be possible, manufacturers are getting close with single-use equipment and modular facility design. With the development of structural, component, or subsystem pieces that are standardized and able to be assembled in virtually limitless ways, pharmaceutical companies can quickly and easily set up their manufacturing facilities. In addition to efficiency, single-use equipment and modular facility designs offer benefits including cutting costs, increasing output, and even boosting sustainability.
Perhaps the most obvious sign of the single-use facility design taking hold is its burgeoning presence in the current market. Although single-use equipment accounts for only about 10 percent of manufacturing of approved drugs, 75 to 80 percent of the biotech drugs in the midst of clinical trials utilize this equipment design.
Single-Use Technologies Offer Multiple Benefits
As the name suggests, single-use equipment is used only once in a pharmaceutical manufacturing facility. The pieces are switched out after the creation of each new batch of pharmaceuticals (or in some cases, after each campaign). This eliminates the need for equipment cleaning and re-sterilization throughout the manufacturing process, saving time and costs. Manufacturers do not need to halt production or allocate extra time to prepare the various components for the subsequent batch. They also no longer must purchase cleaning supplies for that purpose, dispose of used cleaning fluids, or use excessive amounts of water for cleaning, rinsing, and steam generation. Reducing cleaning materials, eliminating downtime, and keeping production in motion lead to overall improvements to the bottom line.
Greater benefits of the single-use design lie in alleviating concerns of facility equipment being unclean or compromised. Replacing pieces with systems that are virgin, pre-assembled, and pre-sterilized eliminates the worry about sterilization, cleanliness, or exposure. Using fresh materials means the drug has a lower risk of contamination during production. Ultimately this benefits consumers and helps protect brand reputation.
Investing In Long-Term Sustainability
Despite its benefits in reducing bottom line costs for manufacturers, at first glance, single-use facility design seems to run counter to the pharmaceutical industry’s commitment to sustainability. Typically, the terms “recyclable” and “reusable” go hand-in-hand with sustainability. Manufacturing components are usually required to have these characteristics to qualify as environmentally friendly; however, in the case of single-use components, the matter is not so simple.
Made from a combination of plastics that are not themselves recyclable, incinerating or melting down single-use systems and converting them into reusable energy makes the systems infinitely recyclable. By the same token, eliminating the cleaning and sterilization processes for the materials saves significant water and energy. For manufacturers considering switching to this type of facility design, looking at the bigger picture is key. Although single-use pieces do not appear to be eco-conscious at the outset, they do offer pharmaceutical companies a long-term investment in sustainability.
Modular Design Offers More Flexibility
Modular facility design may also be a game-changer for pharmaceutical manufacturers seeking a more efficient building method and the ability to grow or change locations. This design option, which implements standardized structures as simple building blocks for the factory setup, allows for flexibility and easy expansion. With these modular components, manufacturers can assemble a facility in a fraction of the time needed for traditional setup, saving costs and building time. These pieces also do not require the expanse of stainless steel tanks and piping for transport of rinsing materials, cleaning solutions, and steam seen with traditional stainless-steel design facilities, so they are not as difficult to assemble and cost less.
No pharmaceutical company predicts their drug failing in the marketplace, but the modular design holds another benefit in this respect. If a drug isn’t successful and production must cease, the modular design allows for quick dismantling or conversion. The parts can be rearranged with relative ease to fit the design for a new drug. The standardized nature of the modular pieces also means a manufacturer has flexibility in factory size. A facility can shape-shift relatively quickly to accommodate the size and setup required for a different drug. If a manufacturer wants to rearrange their setup, they can do so, or if they want to build vertically, they need less square-footage.
Facility Design To Foster A Global Footprint
Standardizing manufacturing materials and equipment may also hold the key to quick pharmaceutical expansion on a global basis. Returning to the LEGO comparison, the design of a pharmaceutical facility can offer great flexibility and simplicity when each piece fits a mold. There may be a rather limited selection of LEGO brick shapes, sizes, and colors, but the pieces can be used to create seemingly endless designs. In addition, they all fit together the same way and can be attached or detached with ease. Often pre-fabricated and shipped in containers, modular pieces are suitable for manufacturers looking to open new facilities around the world. If they use components that reflect this standardization and familiarity, sophisticated facilities can be replicated in markets where construction might otherwise be difficult or time-consuming.
Opening additional global facilities is key for pharmaceutical manufacturers looking to meet international demand for vaccines and other drugs that have already been maximized in North American or European markets. Standardized modular facilities with single-use equipment can be assembled anywhere in the world and are not dependent on sophisticated local engineering, capital, and resources. By using a modular facility design in developing countries, pharmaceutical companies can build facilities more cost-effectively, allowing them to set local drug or vaccine prices to meet emerging market needs.
Combined Facility Designs Lower The Bottom Line
The result of this increased control is the ability to quickly change the flow or size of production as necessary, meaning less labor, lead time, downtime, and new equipment costs. Manufacturers can match their facility setup to reflect changes in their sales and success or to adapt to market trends and needs. It is this open-ended flexibility and decreased risk of capital loss that makes a modular facility design highly appealing.
Although each type of facility design offers its own benefits, if a manufacturer implements both single-use and modular facility design in one system, options for flexibility and cutting costs may be unmatched. Modular pieces of equipment can be designed as single-use materials, which can result in smaller or low-level cleanrooms and standardized steps of purification. Marrying these methods can also cut down on resources and assembly time, reducing costs on a pharmaceutical manufacturer’s entire operation. Combining these facility designs may also allow for a speedier entry into the market.
About The Author:
Jerry Martin is an independent consultant to pharmaceutical manufacturers and equipment suppliers for filtration, single-use manufacturing, marketing, business development, and regulatory compliance. He was previously SVP, marketing and global scientific affairs, for Pall Life Sciences, where he served the pharmaceutical, biotech, medical device, and vaccine industries for over 37 years. He is currently chairman emeritus of the Bio-Process Systems Alliance, the single-use manufacturing trade association, and a member of the USP Expert Panel on Plastic Systems Used for Manufacturing Pharmaceutical Products. He holds an M.Sc. in microbiology from the University of Toronto.
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