Research Article

Scale-Up of a Medicinal and Aromatic Plant-Based Shampoo Formulation: Physicochemical Quality, Microbiological Safety, and Stability Analyses

Volume: 9 Number: 2 July 17, 2026
EN TR

Scale-Up of a Medicinal and Aromatic Plant-Based Shampoo Formulation: Physicochemical Quality, Microbiological Safety, and Stability Analyses

Abstract

This study investigated the scale-up process of a plant-based shampoo formulation developed for dry and damaged hair, evaluating its quality, safety, and stability parameters across laboratory, pilot, and industrial production scales. The formulation comprised nonionic and amphoteric surfactants (decyl glucoside, coco glucoside, cocamidopropyl betaine), moisturizing and antistatic agents (D-panthenol, sodium lactate), plant-derived keratin, and essential oils of medicinal lavender and rosemary. The formulation was initially developed at a 100 mL laboratory scale. Following systematic optimization of process parameters—including mixing speed, mixing time, phase addition sequence, and mechanical stirring conditions—the formulation was successfully scaled to a 3,000 mL pilot scale and subsequently to a 40,000 mL industrial production scale. Physicochemical parameters including pH, viscosity, and density were monitored at each stage using calibrated instrumentation: a digital pH meter, a Brookfield-type rotational viscometer, and volumetric density calculations. Microbiological safety and antimicrobial efficacy assessments were conducted on the industrial-scale batch in accordance with relevant ISO standards. Microbiological analyses included total aerobic mesophilic microorganism enumeration and screening for Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Candida albicans. Preservative system efficacy was evaluated via challenge testing per TS EN ISO 11930, with logarithmic reductions in microbial counts recorded. Accelerated stability studies encompassing varied temperature, centrifugation, and storage conditions confirmed consistent pH, viscosity, physical appearance, and microbiological integrity throughout. The results demonstrated that the formulation retained its physicochemical characteristics across all production scales while meeting microbiological safety requirements. These findings highlight the industrial scalability of naturally derived hair care formulations and emphasize the critical role of rigorous quality control protocols in cosmetic manufacturing.

Keywords

Scale-up, Shampoo formulation, Medicinal and aromatic plants, Preservative efficacy, Herbal cosmetics, Process validation, Stability studies

Supporting Institution

Düzce University Coordination for Specialization in Environmental and Health Technologies

Project Number

K22323

Ethical Statement

This study did not involve any human participants or animals. Therefore, ethics committee approval was not required.

Thanks

The authors thank Düzce University Coordination for Specialization in Environmental and Health Technologies for project support, budget facilities, and laboratory infrastructure provided for this study (Project Number: K22323). A preliminary version of this work was presented as an oral presentation at the "1st National Regional Development Congress" organized by Düzce University, Düzce, Turkey, on April 20–22, 2026.

References

  1. Abelan, U. S., Oliveira, A. C., Cacoci, E. S. P., Martins, T. E. A., Giacon, V. M., Velasco, M. V. R., & Castro Lima, C. R. R. (2022). Potential use of essential oils in cosmetic and dermatological hair products: A review. Journal of Cosmetic Dermatology, 21(4), 1407–1418.
  2. Burnett, C. L., Bergfeld, W. F., Belsito, D. V., Hill, R. A., Klaassen, C. D., Liebler, D. C., Marks, J. G., Shank, R. C., Slaga, T. J., Snyder, P. W., & Andersen, F. A. (2012). Final report of the cosmetic ingredient review Expert Panel on the safety assessment of cocamidopropyl betaine (CAPB). International Journal of Toxicology, 31(1), 77S–111S.
  3. Burnett, C. L., Bergfeld, W. F., Belsito, D. V., Hill, R. A., Klaassen, C. D., Liebler, D. C., Marks, J. G., Shank, R. C., Slaga, T. J., Snyder, P. W., Gill, L. J., & Heldreth, B. (2021). Safety assessment of keratin and keratin-derived ingredients as used in cosmetics. International Journal of Toxicology, 40(2), 36S–51S.
  4. Chen, T., & Chang, H. (2024). Deciphering trends in replacing preservatives in cosmetics intended for infants and sensitive population. Scientific Reports, 14, 19053.
  5. Dias, M. F. R. G., Almeida, A. M., Cecato, P. M. R., Adriano, A. R., & Pichler, J. (2014). The shampoo pH can affect the hair: Myth or reality? International Journal of Trichology, 6(3), 95–99.
  6. Durgun, M. E., & Algın Yapar, E. (2021). A critical step for the cosmetic industry: Scale-up. Universal Journal of Pharmaceutical Research, 6(3), 77–82.
  7. Grand View Research. (2024). Organic shampoo market size, share & growth report 2024–2030. Grand View Research. Retrieved from https://www.grandviewresearch.com
  8. Gubitosa, J., Rizzi, V., Fini, P., & Cosma, P. (2019). Hair care cosmetics: From traditional shampoo to solid clay and herbal shampoo, a review. Cosmetics, 6(1), 13.
  9. Hyldgaard, M., Sutherland, D. S., Sundh, M., Mygind, T., & Meyer, R. L. (2012). Antimicrobial mechanism of monocaprylate. Applied and Environmental Microbiology, 78(8), 2957–2965.
  10. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (1995). ICH Harmonised Tripartite Guideline: Stability Testing of Biotechnological/Biological Products. Q5C 4.0, 1-10.
APA
Dikmen Küçük, S., & Karadeniz, B. (2026). Scale-Up of a Medicinal and Aromatic Plant-Based Shampoo Formulation: Physicochemical Quality, Microbiological Safety, and Stability Analyses. Journal of Apitherapy and Nature, 9(2), 161-172. https://doi.org/10.35206/jan.1943967
AMA
1.Dikmen Küçük S, Karadeniz B. Scale-Up of a Medicinal and Aromatic Plant-Based Shampoo Formulation: Physicochemical Quality, Microbiological Safety, and Stability Analyses. J.Apit.Nat. 2026;9(2):161-172. doi:10.35206/jan.1943967
Chicago
Dikmen Küçük, Sibel, and Beste Karadeniz. 2026. “Scale-Up of a Medicinal and Aromatic Plant-Based Shampoo Formulation: Physicochemical Quality, Microbiological Safety, and Stability Analyses”. Journal of Apitherapy and Nature 9 (2): 161-72. https://doi.org/10.35206/jan.1943967.
EndNote
Dikmen Küçük S, Karadeniz B (July 1, 2026) Scale-Up of a Medicinal and Aromatic Plant-Based Shampoo Formulation: Physicochemical Quality, Microbiological Safety, and Stability Analyses. Journal of Apitherapy and Nature 9 2 161–172.
IEEE
[1]S. Dikmen Küçük and B. Karadeniz, “Scale-Up of a Medicinal and Aromatic Plant-Based Shampoo Formulation: Physicochemical Quality, Microbiological Safety, and Stability Analyses”, J.Apit.Nat., vol. 9, no. 2, pp. 161–172, July 2026, doi: 10.35206/jan.1943967.
ISNAD
Dikmen Küçük, Sibel - Karadeniz, Beste. “Scale-Up of a Medicinal and Aromatic Plant-Based Shampoo Formulation: Physicochemical Quality, Microbiological Safety, and Stability Analyses”. Journal of Apitherapy and Nature 9/2 (July 1, 2026): 161-172. https://doi.org/10.35206/jan.1943967.
JAMA
1.Dikmen Küçük S, Karadeniz B. Scale-Up of a Medicinal and Aromatic Plant-Based Shampoo Formulation: Physicochemical Quality, Microbiological Safety, and Stability Analyses. J.Apit.Nat. 2026;9:161–172.
MLA
Dikmen Küçük, Sibel, and Beste Karadeniz. “Scale-Up of a Medicinal and Aromatic Plant-Based Shampoo Formulation: Physicochemical Quality, Microbiological Safety, and Stability Analyses”. Journal of Apitherapy and Nature, vol. 9, no. 2, July 2026, pp. 161-72, doi:10.35206/jan.1943967.
Vancouver
1.Sibel Dikmen Küçük, Beste Karadeniz. Scale-Up of a Medicinal and Aromatic Plant-Based Shampoo Formulation: Physicochemical Quality, Microbiological Safety, and Stability Analyses. J.Apit.Nat. 2026 Jul. 1;9(2):161-72. doi:10.35206/jan.1943967