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.
Common Misconceptions About Terminal Sterilization
If a decision is made to not terminally sterilize a product, manufacturers need to be prepared to provide justification for making the decision, given how effective and safe terminal sterilization has become. Product degradation and container closure studies will be required in order to determine that the decision is a valid one.
One of the main reasons some do not use terminal sterilization has been the common misconception of the overkill type methods. Some products have nearly no bioburden and have previously been perceived to not need these overkill methods. However, drug manufacturers are cautioned to not disqualify their product from terminal sterilization simply based on the product not being able to withstand overkill conditions. Instead, figuring out the right type of terminal sterilization that establishes SAL without degrading the product should always be an alternative solution.
Terminal Sterilization Saves You Time & Money
Additionally, manufacturers of drug products that are terminally sterilized might want to consider less stringent aseptic controls. As a result, redundant filtrations, integrity tests, and personnel monitoring measures could be reduced, resulting in substantial savings. Moreover, the reduction or elimination of aseptic controls might enable staff to be repositioned so that they are no longer required to perform labor-intensive quality control and clean room monitoring tasks, which would result in even greater savings.
The MediZap Difference
MediZap specializes in electron beam and X-ray terminal sterilization. The benefits of this methodology in comparison to dry heat and steam heat are a reduction or elimination of deleterious effects on your drug.
Learn more about our e-beam sterilization services.