To help engineers determine whether their products or packaging could be affected by light, DDL Inc. has added photostability testing at its Eden Prairie, MN, lab. The testing can simulate any lighting that a product or package may experience, such as sunlight or fluorescent light.
Pharmaceutical and cosmetics are the two big market segments for photostability growth, Corey Hensel, DDL’s General Manager, tells PMP News. “For pharmaceuticals, the primary guidance comes from ICH Q1B. ICH requires multiple levels of test and check,” he explains. “From raw product to immediate pack to marketing pack, each level requires a check for an acceptable amount of change and makes recommendations for formulation or packaging change. The goal of photostability testing is to find a light-stable formulation.”
ICH Q1B is simply a guidance, it is not a requirement, he adds.
“For cosmetics, the primary guidance on stability studies comes from the Colipa Guidelines, which provide a method for predicting shelf-life of cosmetic products,” Hensel adds. (Cosmetics Europe now serves as the European trade association for the cosmetics and personal care industry.)
Not all types of packages require testing, Hensel says. “However, any package impacted by light should be considered for testing,” he explains.
After light exposure, testing samples are compared with a control sample to determine whether significant changes have occurred.