Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) Roles in the Pilot Scale up Process and Stability of a Cosmetic Cream

Abstract

Introduction: The objective of this study was to scale up a natural based cream containing Piper betle L. extract to pilot scale and asses it’s stability over time. Method: During the scale up process, the critical process parameters (CPP) were monitored closely to ensure the critical quality attributes (CQA) are maintained within a desired range. To ensure the formulation was stable, a 6-months stability study was done where the organoleptic properties, particle size, zeta potential, viscosity, microbial limit and hydroxchavicol content were assessed. The formulation was characterized repeatedly at 0-month, 1-month, 2-month, 3-month and 6-month time point after being stored in 30°C±2 and 40°C±2 at 75%±5% RH. Results: CPPs in each process were maintained at certain values throughout to achieve CQAs. Time, speed and temperature during mixing and homogenization process were monitored and maintained. Stability study over 6 months proved the ability of the product to remain stable with pH < 5, particle size < 2µm, low span value, zeta potential < -50mV, apparent viscosity < 1.2Pa.s­¹ and no microbial growth. Conclusion: In conclusions, CPPs played a major role in enabling the formulation produced attain acceptable CQAs. Identifying CQA and CPP ensured the production of quality and stable product.

Keywords

• scale up
• pilot scale
• manufacturing
• piper betle
• cosmetic cream