Run a pilot batch to complete the scale-up validation process

Formulation development doesn’t end on the lab bench or after analytical testing and stability data provide desired results. Taking your promising idea from formulation to commercial-ready product involves our Commercial-Scale Validation service. During this phase of development, we run your formulation through our pilot plant production using adequate test volumes.

“Our Commercial-Scale Validation service is a critical step between laboratory development and full commercial production. Skipping this phase where we run a pilot batch can lead to failed commercial runs, off-spec product, wasted raw materials, and lost production time. On the commercial scale, a single failed batch can cost tens of thousands of dollars, or more. The commercial-scale validation step using our pilot plants is a relatively small investment that helps avoid costly rework or product disposal,” explained Victoria Maskule, one of our analytical chemists.

Our Commercial-Scale Validation service uses our pilot plant facilities to simulate a commercial batch. A pilot batch uses the same type of equipment that would be used in commercial production, but on a smaller scale. Equipment should include stainless steel vessels, high-shear mixers, mills and homogenizers. Running an effective pilot batch means producing a significant volume (at least 100 gallons) using the process defined by the formulator. 

“While formulas may perform well at the bench scale, they may encounter issues when scaling up. Larger batch sizes introduce variables that simply don’t exist in small lab beakers. These variables can include heat transfer, mixing efficiency, raw material loading sequences, reaction times, equipment geometry, and shear forces. Differences with any one of these can change the product’s stability, performance, or safety profile,” Maskule said.

As part of our Commercial-Scale Validation service, our highly skilled process operators and quality-control technicians monitor and test each step of the process to ensure the integrity of your product is maintained throughout the production cycle. If we uncover any process or quality issues, we can work with you to correct them before large quantities are put at risk in a commercial production environment, which creates financial and operational risk. 

By incorporating our Commercial-Scale Validation service into your product commercialization plans, you can:

  • Validate the bench formulation behaves the same at scale.
    • Pilot production helps confirm that the product maintains the same physical properties, solubility, dispersion behavior, and long-term stability as the lab batch.
  • Identify scale-dependent issues early.
    • Some problems only appear at larger volumes, such as:
      • Unexpected viscosity changes
      • Mixing or dispersion inefficiencies
      • Different interactions of raw materials under different energy inputs
      • Equipment-related challenges
    • Identifying these issues in the pilot plant prevents surprises during commercial manufacturing.
  • Optimize the process for manufacturing.
    • Pilot batches allow the team to:
      • Refine the order of ingredient addition
      • Adjust mixing speeds or temperatures
      • Confirm cycle time
      • Ensure the process is reproducible and robust
    • This step builds confidence that the commercial process will run smoothly and consistently.

 

 

Beyond using our Commercial-Scale Validation service to ensure scale-up success of your product, our Custom Small-Batch Production service allows you to produce smaller volumes for trials, registration or initial launch. Our Custom Small-Batch Production service is also helpful when you’re trying to bridge capacity constraints at your facilities or fill unanticipated demand. In addition, our facilities can accommodate specialized packaging needs that some larger manufacturers are less inclined to produce.