Problem: The chosen supplier for the balloon fill media (the liquid portion of a Class III PMA medical device) was sourced as an aseptic fill process, resulting in large cash outlay for each batch of materials. This material carried a 4-year validated shelf-life. The desire was to validate terminal steam sterilization without losing the 4-year shelf-life. Product was running low and an expensive revalidation of the aseptic process was coming due.
Solution: A literature search was used to find data to rationalize the idea that the only unknowns for this change were the integrity of the vial seal and the quality of the product after exposure to terminal steam sterilization. These two unknowns were tested and verified to be unchanged allowing for an adoption of the 4-year shelf-life. A terminal steam sterilization provider was identified, and the process was validated all within 7 months. The terminally sterilized product was produced at a third of the cost of the aseptically processed product resulting in a savings of $1MM for the first year.