Case Study: Scaling a Nutritional Formula from Bench-Top to Full Production
Client Challenge
After months of meticulous formulation work in the lab which involved perfecting flavor, mouthfeel, appearance, and active ingredient balance, a new nutritional product was ready for scale-up. The team had optimized every detail in small batches and was confident in the formula’s readiness for commercial production.
Objective
Transition the formula from bench-top batches (a few liters) to full-scale manufacturing (hundreds to over 1,000 gallons) while maintaining product integrity and quality.
Process Overview
- Manufacturer Selection: A contract manufacturer was chosen based on equipment compatibility, ingredient handling capabilities, and quality protocols.
- Raw Material Procurement: All ingredients were sourced and verified for consistency with lab-grade inputs.
- Batch Preparation: Water was added to both the main and hot mixing tanks, replicating the bench-top process.
Challenges Encountered
- Unexpected Foaming During Mixing
- Observation: Significant foaming occurred during the addition of early ingredients—nearly overflowing the tank.
- Cause: Likely due to increased shear forces at scale, which were not present during lab development.
- Mitigation: On-site antifoam agents were used to control the issue, allowing the batch to proceed.
- Holding Tank Dwell Time
- Situation: After QC approval, the batch was transferred to a holding tank with cooling capacity.
- Delay: Packaging was postponed due to ongoing production of another item, resulting in a 24–36-hour dwell time.
- Concern: Certain ingredients were known to be heat-sensitive, and this delay introduced risk of degradation—an untested variable in the lab.
- Packaging Line Disruptions
- Foaming During Fill: More pronounced than in lab conditions but manageable.
- Color Shift: Product appeared slightly tan, raising questions about thermal impact or ingredient interaction.
- Flow Drop: Mid-run, the inline filter clogged due to insoluble particles from a key active ingredient.
- Resolution: Filter was cleared, but uncertainty remained about how much active was lost during the blockage.
Outcome
The production run yielded thousands of cases, marking a significant milestone in the commercialization journey. However, several deviations from the bench-top formulation were observed, raising questions about consistency and long-term product performance:
- Appearance and Color Variation: The final product exhibited a noticeable tan hue, diverging from the original lab version. This shift may be attributed to thermal exposure during extended dwell time or ingredient interactions at scale.
- Potential Loss of Active Ingredient: A mid-run clog in the inline filter, caused by insoluble particles from a key active, halted flow and required manual intervention. While the line resumed, the quantity of active lost remains uncertain, potentially impacting efficacy.
- Unanticipated Process Variables:
- Foaming: Excessive foam during mixing and filling, likely due to increased shear forces, introduced risk of overflow and slowed operations.
- Dwell Time: The product sat in a warm holding tank for up to 36 hours before packaging, far longer than lab conditions, raising concerns about degradation of sensitive ingredients.
- Filtration Challenges: The clogging incident revealed the need for better understanding of ingredient solubility and filtration compatibility at scale.
These issues underscore the complexity of scaling a formula and the importance of anticipating how process dynamics can influence product quality.
Key Takeaway
While direct scale-up from bench-top to full production is achievable, it carries significant risk without intermediate validation. This case illustrates why pilot plant trials are a critical step in the commercialization process. By simulating production conditions at a smaller scale, teams can:
- Identify shear-related effects that may alter texture, foam behavior, or ingredient dispersion.
- Evaluate ingredient stability under realistic dwell times, thermal exposure, and holding conditions.
- Validate filtration and packaging dynamics, ensuring that actives remain intact, and equipment can handle the formulation without disruption.
A well-planned pilot run not only reduces uncertainty, it protects brand integrity, minimizes costly rework, and builds confidence in the final product’s performance across the supply chain.
