ABSTRACT
In the manufacturing and packaging of medical devices, the ideal situation is to reduce or eliminate spikes as much as possible by operational and quality controls. However, there are many situations where spikes are a normal, consistent part of the overall device bioburden. The bioburden will tend to fluctuate within a range broader than the range for synthetic devices. In other situations, there can be a normal fluctuation of the bioburden due to manufacturing or handling, and it may not be necessary or feasible to institute procedures to reduce or control the fluctuation. The decision to use a spike should be made only after careful evaluation of the historical bioburden data, as well as other data pertinent to the sterilization and validation processes. The use of bioburden spikes was originally incorporated in the International Organization for Standardization 13409 document as a standard practice in the validation of a dose for radiation sterilization.
