The times are changing, so are the methods in which the pharmaceutical sector used to function. "Conservative" pharma companies are now moving outside the traditional manufacturing paradigm, investigating new routes to handle unexpected sales estimates and small scale production.
As new drug delivery techniques emerge, pharma companies must develop manufacturing capabilities that are flexible enough to meet the market's changing needs while also being more responsive. Flexible manufacturing in the pharma sector is gaining traction as a viable method for overcoming these obstacles. Traditional manufacturing setups, consisting of equipment for various processes, are no longer sufficient to fulfill the production demands of novel medicinal items with low volumes.
This technique is not only inefficient, but it also necessitates more financial and physical resources. In addition, the following growing developments in the pharma environment necessitate a flexible approach to production in order to generate further efficiency. In this article, let's look at the key trends of the pharma industry influencing the flexible manufacturing process.
Single Use
With the confluence of two complementing modern technologies, single-use systems and continuous production methods, a paradigm change in biopharmaceutical production is taking place. Cleaning, sterilization, and validation stages are eliminated with single-use pre-sterilized and disposable polymer-based components.
They also reduce the danger of contamination during product changes, lower production and energy costs, reduce plant footprints, and save time and labor. When compared to reusable steel equipment, the environmental effect is advantageous. In a pharmaceutical production plant, each batch of drugs necessitates the creation of new parts.
This saves time and money by eliminating the need for equipment cleaning and re-sterilization throughout the manufacturing process. Manufacturers do not have to stop production or set aside additional time to prepare the various components for the next batch. They also don't have to buy cleaning materials for that, dispose of spent cleaning fluids, or use a lot of water for cleaning, rinsing, or steam generating. Overall profits are improved by reducing cleaning materials, avoiding downtime, and keeping production moving.
Modular Approach to Increase Flexibility
Pharmaceutical businesses seeking a more efficient building approach as well as the capacity to develop or relocate may find modular facility design to be a game-changer. This design choice provides for flexibility and natural extension by using standardized structures as simple building blocks for the manufacturing setup.
Manufacturers can put together a facility in a fraction of the time it takes to put together a typical facility, saving money and time. These items also don't need the stainless-steel tanks and piping that standard stainless-steel design facilities use for transporting rinse chemicals, cleaning solutions, and steam, so they're easier to put together and less expensive.
Although no pharmaceutical firm expects their medicine to fail in the market, the modular architecture provides for swift deconstruction or conversion if a drug fails and manufacturing must be halted. To match the model for a new medicine, the pieces may be adjusted quite easily.
A facility may swiftly change design to fit the size and setup requirements for a new medicine. If less space is needed, a producer can even construct vertically. Standardizing production materials and equipment might also assist accelerate global pharmaceutical growth.Companies may mix and match parts as needed based on product and location if each piece of equipment at a facility is comparable or standard.
Adding or deleting from a facility may also be done with simplicity if they all fit together in the same way. Modular parts, which are frequently prefabricated and carried in containers, are ideal for firms wishing to create new facilities throughout the world.
Sophisticated facilities may be duplicated in markets where building would normally be difficult, if not impossible, provided they employ components that represent this uniformity and familiarity.
Data-driven manufacturing
The emergence of the fourth industrial revolution is reshaping the old pharmaceutical production paradigm. The "big data" and "IoT" platforms provide pharma producers significant potential to transform regular operational data into useful insights and knowledge. Pharma businesses may use this information to embrace proactive management and develop new methods to improve output and reduce risk. Manufacturers can handle operations more effectively and plan better with real-time process visibility.
The way forward
With the wide, complicated product portfolios and uncertain, changeable market circumstances, pharma companies must now consider another element, in addition to time and cost: adaptability. Fortunately, technological advancements and the advent of IoT platforms have given the pharmaceutical business sufficient resources to build new strategic production models that will meet the present problems. Flexible manufacturing has the ability to meet the pharma production setup's future expectations and move it to the next level with amazing outcomes. The only question is whether the pharmaceutical sector is ready to adopt this new strategy.
, CDSCO.jpg)
