Sterile and aseptic product formulation and filling processes must be performed in controlled environments with minimal exposure to microbes, chemicals, or particulates. The essential sterile product manufacturing activities are completed in classified environments that conform to the International Organization for Standardization (ISO) procedures. The lower the number for ISO cleanroom classification, the cleaner the processing environment.
Sterile and aseptic filling service providers offer expertise that includes product development, manufacturing, analytical testing and regulatory support.