What is Aseptic Manufacturing?
Aseptic manufacturing is a manufacturing method that can produce bacteria-free products. Aseptic manufacturing is the key to keeping your patients safe from harmful bacteria. This method can produce sterile products without having any need for extensive sterilization, which means you’ll never have to lose effectiveness or give someone an infection because they underwent harsh cleaning procedures before receiving treatment.
Aseptic Processing Vs. Terminal Sterilization
Aseptic processing is different from terminal sterilization. Sterilization occurs differently for each process. Sterilization happens after the API, containers, stoppers, and excipients have been assembled in terminal sterilization. Once assembled, the product is exposed to high heat or radiation to make it sterile. In aseptic processing, the drug product and the excipients, the stoppers, and the containers need to be individually sterilized. After that, they are introduced into a sterile manufacturing core or cleanroom. The final product must be monitored for microbial signs or growth in aseptic processing.
Challenges of Aseptic Manufacturing
Aseptic manufacturing needs highly trained and qualified personnel to perform the tasks, follow the steps, and manage the specialized equipment. They must be on top of the cleaning procedures and constantly monitor environmental factors even when the manufacturing area is not being used. That will help determine or prevent the aseptic process from being compromised. That’s because the risk to the products and patients is high in case of contamination.
Choosing an Aseptic Manufacturing Firm
When you look for a manufacturing company to provide aseptic processing solutions, consider the following:
- Does the company have a separate, clean area for the aseptic manufacturing process? Is the area classified? You need to make sure it’s not easily compromised.
- Ask about that space. Is the air in there filtered and circulated properly? Lack of proper ventilation can lead to moisture and mold growth. It can also compromise products and processes.
- Does the company sterilize and maintain the closures and containers? How often do they clean them?
- What about the personnel? Do they go around in sterile clothing? What about their training? Are they closely monitored? Are they trained and experienced?
- Does the company have time limits for different steps of the manufacturing process?
- Does the company simulate and record the manufacturing process? That will help you get a more accurate perspective on what happens during the process. If there are any problems or weaknesses, you can point them out and discuss possible solutions with the manufacturing company.