Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated we can assure that the final product is of the best quality. This paper presents an introduction and general overview on process validation of sterile liquid products. Main objective is to maintain the sterility of a product, assembled from sterile components Validation of aseptic processing should include a process simulation test using a nutrient medium (media fill). Validation of aseptic processes relies upon prospective, concurrent and retrospective validation as well as re-validation.
Loading....