Environmental Monitoring Program for Aseptic Vaccine Products

摘要

This article is primarily about the Environmental Monitoring (EM) program that should be in place for biological products including bacterial and viral vaccines, although there is also mention of testing of raw materials and finished product as well. Biological products are derived from cells, tissues or microorganisms through cell culture growth/fermentation, extraction of substances of interest, isolation and purification leading to formulation and filling. Products include allergens, antigens, hormones, enzymes, monoclonal antibodies, immune animal sera, fermentation products and bacterial and viral vaccines.