Drug sponsors want to introduce new products to patients as fast as possible so that they can impact their lives. The discovery of a new drug means that manufacturers have a finite amount of time to reap the benefits. If they wait too long, its patent will expire and more generic products will instead enter the market. To deliver on these new drugs, the manufacturing facility responsible for its creation needs to have a proper outline. This, above all else, is why pharmaceutical plant construction and design should not be taken lightly.
Facility types for pharmaceutical plant construction
Generally speaking, there are three types of pharmaceutical facilities:
- Single-floor: This facility is the cheapest to build and/or lease. However, the height of the ceiling could force constraints. Still, even with single-floor buildings, intermediate bulk containers (IBCs) can help achieve full batch transfer from one process to another. As a result, it will reduce the number of wasted products.
- Two-floor: Facilities with two floors are more expensive to build and/or lease. Nevertheless, IBCs can aid in separating materials handling and blending on the top floor. And it can do so from tableting and packing operations on the bottom floor.
- Multi-floor: While expensive, these facilities have a lot of available space and are very flexible. However, space can be wasted if you do not take the factory’s layout and production flow into consideration. IBCs can utilize height and space while simultaneously offering the chance to incorporate new technologies. This way, the efficiency of each production area can undergo maximization.
The type of layout you choose for your pharmacy design ultimately depends on your line(s) of product. For example, consider the layout of an industry refining raw materials to produce Active Pharmaceutical Ingredients (API) for pharmaceutical manufacturing. Likewise, those that create excipients or ancillary substances. Their design is typically different from the layout of an industry processing dosage forms (injections, tablets, etc.) from raw materials or intermediate products.
Decisions and risks to consider
As a new facility’s design develops, drug sponsors are suddenly facing many decisions. They are quite similar to the criteria that would go towards choosing the right contract development and manufacturing organization (CDMO). However, additional decisions include an understanding of business performance drivers, like risk tolerance and supply chain considerations.
One must take certain factors into account, such as the following:
- The predicted timing for return on investment (ROI)
- Space allocation
- Selecting suitable information technology systems
- The accounting decisions that will be devalued and leave a long-term impact on the balance sheet
Instead of depending on others to execute manufacturing processes, the drug sponsor needs to monitor the project. Additionally, they need to make decisions along the way in order to guide the project to reach completion on schedule.
Working in sync
A product in the early phases of development obviously needs to evolve before it becomes functional for commercial manufacturing. What happens in lab-scale for trials in early phases is not scalable without considerable effect on the operation. Alternatively, a serious impact on the manufacturing environment.
Hand manipulations on a tabletop inside a laboratory practice environment need to develop into a fully defined procedure. One that will likely reach automation by Phase III to commercial launch and large-scale production. The necessities for labs – such as environmental observation and frequency – are less strict than wide-ranging good manufacturing practice (GMP) manufacturing facilities.
Certain requirements of GMP facilities include:
- Walls or floors that have coved bases
- Cleanable facility surfaces
- Separation of personnel and material entry and exit
- Step down between room arrangements
- Strong ventilation, heating, and air conditioning systems that rely on biological classification
By synchronizing process development with the capability of a facility, then upon startup, it can promptly grasp design capacity. Opportune project scope definition and establishing priorities can effectively simplify the project’s execution and produce top-notch delivery. The practices that drug sponsors currently utilize have shortcomings that can undergo minimization with the appropriate effort and preparation.
Closing thoughts on pharmaceutical plant construction
Overall, pharmaceutical plants are intricately refined production environments. Therefore, to properly operate, they need a high degree of planning regarding functions, regulations, and structure. If you need quote on your next pharmaceutical plan construction build, be sure to contact our Calgary construction location.