Cleaning Validation of Sterile Area. Cleaning Validation

      Аннотация: Cleaning validation of sterile area is one of the most important and tedious working in pharmaceutical industry. Present work was carried out for cleaning validation of sterile area in which cleaning validation as well as analytical method validation with respect to oxytertracycline was performed. The validation was conducted according to written protocols i.e. validation protocol. The results of this validation study were complied in validation report. Analytical method was developed based on certain parameters. The parameters studied were Linearity, Accuracy, Precision and Recovery. These parameters were established using UV spectrophotometer. The two methods used for sampling were rinse sampling and swab sampling.

Ключевые слова: Cleaning, validation, Analytical Method, Sampling, UV Spectrophotometer, Equipment, sterile