Aseptic pharmaceutical manufacturing requires that all sterile drug products be filled into clean and hygienic containers, then sealed using primary and secondary packaging. However, this practice, though widely used, cannot obtain the Sterility Assurance Level, or SAL of 10-6. This has required new methods of sterilization to be brought to the market.
Why Terminal Sterilization
Terminal sterilization can provide this proper Sterility Assurance Level. This sterilization process has products sterilized in their final container or packaging, which permits the measurement and evaluation of quantifiable microbial lethality. It is an essential process as it ensures the parenteral/injectable drug products remain sterile and without the presence of potential microbial contaminants (fungi, bacteria).
Contamination deems the product unusable and unsafe for the consumer. For this reason, the terminal sterilization process is accepted over aseptic processing – which is only used when terminal sterilization is not an option. Read more >