The Impact of Automation on Aseptic Processing - Pharmaceutical Technology

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The Impact of Automation on Aseptic Processing
The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.


Pharmaceutical Technology


References

1. J. Akers et al., "A Review of Current Technology in Parenteral Manufacturing," J. Paren. Sci. Technol. 42 (4), 53–56 (1988).

2. FDA, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (Rockville, MD, 2004).

3. J. Akers and J. Agalloco, "Aseptic Processing: A Current Perspective," in Sterilization Technology, R. Morrisey and G.B. Phillips, Ed. (Van Nostrand Reinhold, New York, NY, 1993).

4. J. Agalloco, J. Akers, and R. Madsen, "Current Practices in the Validation of Aseptic Processing–2001," PDA Technical Report #36, PDA J. Pharm. Sci. Technol. 56 (3), (2002).

5. J. Agalloco and J. Akers, "Risk Analysis for Aseptic Processing: The Akers-Agalloco Method," Pharm. Technol. 29 (11), 24–32 (2005).

6. J. Akers et al., "Manufacture of a Dual Chamber 'Kit' Product Utilizing a Combination of Aseptic Fill in Isolators and Terminal Sterilization," Proceedings of the ISPE Barrier Isolator Technology Conference, Arlington, VA, June 2007.

7. J.E. Akers, M. Kokubo, and Y. Oshima, "The Next Generation of Aseptic Processing Equipment," Aseptic Processing Supplement to Pharmaceutical Technology, 14–18 (2006).

8. J. Akers, K. Tanimoto, and M. Kawata, "Aseptic Processing the Japanese Way," Pharma.Manufacturing 5 (6), 34–39 (2006).

9. W. Morris and E. Hough, "Risky Business-Aseptic Processing," PDA Letter XLIV (7), 1 (July-Aug., 2008).


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