Good Manufacturing Practice (GMP) regulations and FDA guidance require that bio/pharmaceutical manufacturers must prove that harmful residues or organisms are properly removed during cleaning to predetermined safety levels, thus eliminating contamination of manufacturing equipment. Disinfectant tests are applied to give proof of the efficacy of the cleaning and disinfectant procedure is sufficient to remove or inactive microorganisms including bacteria, yeast, fungi, viruses, molds and mycoplasma. The disinfectant efficacy is required to be established before a new disinfectant can be enrolled in the market.
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