According to Good Manufacturing Practice (GMP) regulations, FDA guidance and USP <1072> manufacturers of finished bio/pharmaceutical products must demonstrate that harmful residues or organisms are properly removed during cleaning to predetermined safety levels, thus eliminating contamination of manufacturing equipment.
Cleaning validations are conducted to show that the cleaning process and frequency, including any mechanical cleaning actions, are sufficient to maintain surfaces in a defined state that is free of product, cleaning chemical residues and objectionable organisms. These studies demonstrate that materials can be cleaned to the desired chemical and microbiological levels.
Disinfectant efficacy studies or disinfectant validation studies are performed to demonstrate that the disinfectants used on surfaces in manufacturing areas, laboratories and other facility areas are effective in inactivation or removal of microorganisms, such as bacteria, fungi (yeast and molds), bacterial spores, viruses and mycoplasma. Disinfectant studies can support cleaning studies by showing that application of the disinfectant reduces or eliminates microorganisms, but they should not be considered a substitute for establishing that the cleaning agents and physical cleaning actions are acceptable.
Eurofins BioPharma Product Testing network of laboratories is experienced in effective cleaning, disinfection and monitoring programs to eliminate chemical cleaning agent residues and microorganism levels on laboratory surfaces and equipment. We perform monitoring of these areas to confirm that chemical residues and bioburden are within acceptable limits for the area.