Aseptic processing requires one to sterilize the product, fill a sterilized container, and seal the container with no chance for reinfection. Sterilization may occur through heat, radiation, high pressure, or other suitable means. Packaging requires clean-room like conditions, so air quality is regulated and bacterial and mold spores are eliminated.
The packaging area must be under positive pressure with sterile-filtered air. Workers must follow especially rigorous hygiene requirements to prevent contamination. Processing systems must be capable of achieving a minimum 5 log reduction of resistant spores, and package decontamination systems must be validated and documented. Finally, the actual processing components upstream of the packaging line must meet special design requirements. For example, pumps are undesirable, and tanks and piping must have highly polished surfaces with high quality welds. Equipment must be designed for steam in place (SIP) so sterilization is assured.
If you would like to build or expand an aseptic or extended shelf life (ESL) production facility, we can help. Contact us to discuss your project.