An important consideration in the development of personal care products is the control of microorganism contamination. To ensure that a consumer-ready product is safe, an appropriate preservation strategy must be established for the development, manufacture and packaging of the formula, thus eliminating unacceptable levels of organisms such as pathogenic bacteria, fungi and mold that could grow and pose a health hazard to the consumer.
It is also important to establish an appropriate written good manufacturing procedure (GMP) protocol for raw material specifications, storage and handling; contamination-free water; and sanitization of equipment—including internal safeguards and aseptic manufacturing operating procedures.
To control contamination, the adequate cleaning of all areas of equipment prior to sanitization is an important first step. Cleaning in place (CIP) systems should be used wherever possible to facilitate a sterile environment prior to processing commencement. Also, high quality water should also be used to rinse cleansing ingredients from the equipment—this applies in the laboratory as well, to eliminate contamination that could produce a negative micro-test of prototype samples under evaluation. Sanitization should include steam heat (water above 100°C) and germicidal products (e.g., chlorine, cationic surfactants and alcohol).
In order to optimize the preservation of a personal care product, the preservative system should provide broad-spectrum activity, efficacy at low concentrations—i.e., the minimum inhibitory concentration (MIC)—and act at optimum pH levels. In addition, it should be soluble in both water and oil phases. Details for optimization of preservative systems are described herein.