Intervention management
The importance of interventions in aseptic processing requires a degree of structure to be established to ensure that practices
are consistent across the organization. The authors recommend that the following sequence of activities be used to accomplish
this.
1. Conduct an informal poll of the entire aseptic processing staff about the interventions they perform. This poll should
ask about inherent and corrective interventions for all processing lines. Surprising as it might seem, the list of interventions
will differ from individual to individual.
2. The interventions should be categorized as inherent or corrective for each line, process, or configuration. Each list should
be reviewed in detail because some of the identified interventions may represent an inordinate contamination risk. Production,
quality, and microbiology experts should determine which interventions should be retained as acceptable practice for that
process. Heroic interventions should be avoided.
Intervention procedures
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3. In conjunction with the aseptic operators, the interventions should be defined with adequate detail to ensure that all
personnel can execute them in a nearly identical manner (see sidebar, "Intervention procedures"). Technically competent individuals
should evaluate the individual intervention procedures to minimize their contamination potential. The procedure should specify
the number or location of any components or filled containers to be removed from the line. The extent of the line clearance
should vary with the location and severity of the intervention. For example, if an unfilled vial falls over on the line without
breaking, its removal may be sufficient to return the line to full operation.†† Were an unstoppered, filled vial to break
and spill, the extent of the necessary line clearance and interventional activity would increase.
4. Once a preferred approach for executing an intervention has been chosen, it should be incorporated into an SOP. Procedures
for corrective interventions must allow for flexibility to address their variability.
5. The aseptic operators should be trained in the various intervention procedures they are expected to perform. Videos of
execution and sequential photographs of the interventions can be beneficial in this effort.
6. The batch records for production lots should maintain a record of each corrective intervention performed. These records
should support the frequency of corrective interventions during process simulation. Inherent interventions already are defined
by other procedures for operation and monitoring of the process, so recording their execution in the lot record may not be
necessary.
7. When the need for a new intervention arises, the supervisory decision may be not to proceed with the new intervention.
In these circumstances, a lot-termination procedure can help secure product materials.
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