Cosmetics manufacturing is regulated by FDA and companies must follow cGMP regulations. In June 2013 FDA published their Draft Guidance for Industry: Cosmetic Good Manufacturing Practices. Cosmetic manufacturers following this guidance can reduce the risk failing to comply with cGMP and reduce the risk of having an unsafe product in the market.
A large majority of FDA warning letters issued to cosmetic companies were due microbial issues. Microbial contamination in cosmetic products poses a major safety risk for patients. Depending on the use a contaminated cosmetic product can cause a major infection to the user. Example contaminated mascara can cause a major eye infection.
Cosmetic manufacturers must control microbial contamination before it affects the final product. The quality of raw materials and water are critical to have proper microbial control. Water is easily contaminated with gram negative organisms such as E coli and Pseudomonas aeruginosa. Raw materials can be contaminated with fungi or other bacteria. Equipment must be well cleaned to avoid carry over contamination or during storage.
Some cosmetic formulation use preservative for their products. For example, cream products that are applies with the hand and are touched many times with bare hands. The preservative system must protect the product and avoid the product from becoming contamination or bacteria to grow in the product.
We can help with QC testing of cosmetic product. PAL performs USP, FDA BAM 23 or PCPC test procedure for microbial testing of cosmetics. We can screen for typical pathogens like Pseudomonas aeruginosa, Staphylococcus aureus, E. coli, fungi and other pathogens. We can perform USP <51> Antimicrobial Effectiveness testing to test the product preservative system.
Controlling the product water activity and pH are excellent ways to reduce the risk of microbial contamination. Products with water activity below 0.91 do not promote growth of most fungi and bacteria. PAL can test you product water activity level.
Part of the product safety is to perform stability studies to ensure the product formulation is stable fo the time it indicates in the label. PAL provides stability studies and testing to ensure the product formulation is stable for the length of the product life.
Contact Prime Analytical Laboratories, LLC to ensure your cosmetic product safety, www.primeanalyticallab.com.