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

References

1. J. Agalloco and J. Akers, "Aseptic Processing" supplement to Pharm. Technol. 31 (5), s8–s11 (2007).

2. J. Agalloco and J. Akers, Pharm. Technol. 29 (11), 74–88 (2005).

3. J. Agalloco and J. Akers, Pharm. Technol. 30 (7), 60–76 (2006).

4. J. Agalloco and J. Akers, "Bioprocessing and Sterile Manufacturing" supplement to Pharm. Technol. 34 (3), s44–s45 (2010).

5. J. Akers, J. Agalloco, and R. Madsen, Pharm. Manuf. 4 (2), 25–27 (2006).

6. J. Agalloco and J. Akers, "Aseptic Processing" supplement to Pharm. Technol. 29 (3), s16–s23 (2005).

7. J. Agalloco, J. Akers, and R. Madsen, "The Future of Parenteral Manufacturing," in Pharmaceutical Dosage Forms: Parenteral Medications, Vol. 3, S. Nema and J. Ludwig, Eds. (InformaUSA, New York, 3rd ed., 2010).

8. J. Agalloco and J. Akers, "Future of Aseptic Processing," in Advanced Aseptic Processing Technology, J. Agalloco and J. Akers, Eds. (InformaUSA, New York, 2010).

9. H. Avallone, J. Parenter. Sci. Technol. 43 (1), 3–7 (1989).

*While helping to revise the Parenteral Drug Association's Technical Report (TR) 22, "Process Simulation for Aseptically Filled Products," the authors learned that other task-force members had had similar experiences. The revised TR has a similar perspective on interventions as this article does. The authors provide here a more complete understanding of the problem that resulted from the slightly vague terminology used in their 2007 effort.

**Please note that the text indicates the same rate of intervention, not the same number of interventions.

†Much like the goal for the amount of contamination in aseptic processing simulations, the goal for the number of interventions also should be zero.

††Mandating the removal of a specific number or segment of additional units in the execution of all corrective interventions increases the risk of contamination if that removal requires increased access to the critical zone.


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