Revisiting Interventions in Aseptic Processing - Pharmaceutical Technology

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Revisiting Interventions in Aseptic Processing
The authors revisit their previous effort to refine the terms that describe interventions and to dispel confusion that arose after the original article was published.

Pharmaceutical Technology
Volume 35, Issue 4, pp. 69-72

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
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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