![]() ![]() ![]() This requirement is addressed in global current good manufacturing practices (cGMPs). Let’s be clear, all drug manufacturing, including solid oral dosage form and terminal sterilization manufacturing are required to have established environmental controls. Why must manufacturers establish environmental controls for aseptic processes?Ī. The aseptic manufacturing process requires the drug product and any excipients, the container, and the stoppers to be individually sterilized before being introduced into the cleanroom or sterile manufacturing core where the final product is manufactured in a highly controlled environment constantly monitored for air quality and potential microbial ingress. ![]() For products that can’t withstand terminal sterilization, manufacturers employ aseptic manufacturing. Terminal sterilization processes are harsh and can have negative effects on the efficacy of the product. The assembled product is then subjected to high heat and/or radiation that renders the final product sterile. In terminal sterilization, the sterilization is performed after the API, excipients, containers, and stoppers have been assembled. The major difference between aseptic processing and terminal sterilization is when the sterilization step occurs in the process. What is the difference between aseptic processing and terminal sterilization?Ī. Aseptic process manufacturing allows these products to be produced in a sterile environment, allowing them to maintain their effectiveness while being safe to inject into patients. Many products degrade and become ineffective when subjected to the harsh conditions of terminal sterilization. Aseptic processing is a manufacturing method that can produce product that is absent of bacteria without subjecting the product to terminal sterilization processes. ![]()
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