Cleaning and Microbial Control within Cosmetic, Consumer Products, and Topical Drug Manufacturing Facilities

Global cGMP regulations for cosmetic and drug products require control of the cleaning and sanitizing practices within the manufacturing process to ensure contaminates do not adversely impact the quality of the products produced. Contaminates can include active pharmaceutical ingredients, non-active ingredients, dyes, fragrances, cleaning and sanitizing agents, microbial organisms, endotoxins, exotoxins, and prions. The acceptable level of contaminates will depend on the contaminate, nature of the product, storage conditions, route of administration and the intended recipient of the product. Laboratory testing is the best way to design successful cleaning procedures. Selection of the sanitizing agent and controlling critical parameters is the best way to ensure success. The cleaning validation life cycle concept changes the emphasis from validation to design and monitoring of the cleaning and sanitizing practices. Design and monitoring of critical parameters ensure control of processes. Monitoring of the process also encourages improvements through change management and real-time scientific-based decisions to out of specification (OOS) results. The presentation will also share cleaning and microbial challenges, such as Burkholderia, as manufacturing facilities improve cleaning and sanitizing practices.