What FDA is saying is that drug manufacturers need to have SOPs in place to prevent microorganisms from the environment and humans from contaminating the product. Production rooms in which non sterile drugs, such as tablets and pills are made have lower microbiological control standard than clean rooms in which sterile injectable drugs are made. I believe that non sterile manufacturing facilities have
Since non sterile drugs are usually consumed orally, bacteria that maybe present on the tablets would be destroyed by stomach acid in humans. Sterile injectable drugs however, are injected directly into human body. Therefore, any bacterial contamination in sterile injectable drugs is much more harmful. According to Dr. Radhakrishna S. Tirumalai, a Microbiology and Sterility Assurance Expert for US Pharmacopeia, sterile products "present the highest risk to patients".
Manufacturing facilities must be routinely sanitized by appropriate disinfectants and equipment need to be sanitized and/or sterilized by processes such as sonicating, steaming, autoclaving, and depyrogenation.
Environmental monitoring programs are put in place to collect data to determine if the manufacturing environment (the rooms, the equipment, & the personnel) are under microbial control during drug manufacturing or static activities. Next blog I will takl about the type of EM, the EM equipment used, alert/action levels.
Keith
