Challenges and Strategies for Implementing Automated Visual Inspection for Biopharmaceuticals - Pharmaceutical Technology

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Challenges and Strategies for Implementing Automated Visual Inspection for Biopharmaceuticals
The authors used a light-transmission-based static division system to detect particles of foreign contaminants in prefilled vials.


Pharmaceutical Technology


Conclusions

AVI of injectable drug products offers several advantages over manual inspection, including process consistency, speed, and potential cost effectiveness. This study investigated the role of machine settings, formulation properties, and fill configuration on the performance of an AVI. Higher spin speed and brake settings were shown to improve detection rates of the AVI system. Product properties such as viscosity, density, and surface tension affect the manner and duration of particle suspension in solution and thereby affect process performance. Other inherent solution properties such propensity to form air-bubbles and/or protein particles can also cause potential interference with the inspection system resulting in false rejections. Low fill volumes are also challenging because of the smaller inspection window. It is suggested that any equipment qualification or process characterization work should evaluate the system performance over a wide range of these process parameters and solution properties to arrive at a robust and consistent visual inspection process. DOEs can be conducted to study these parameters and any potential interactions. Formulation properties and fill configurations can be bracketed to minimize the number of experiments.

Acknowledgments

The authors wish to thank Aarti Gidh, Deborah Shnek, Erwin Freund, and Ed Walls in process development at Amgen for useful discussions and suggestions for this paper. We also thank Jeff Stephens, Ari Levy, and Damien Villanueva in clinical manufacturing at Amgen for providing valuable experimental support toward the execution of these studies.

Nitin Rathore*, is a senior scientist, Cylia Chen is a senior associate scientist, Oscar Gonzalez is a senior engineer, and Wenchang Ji is principal scientist, all in drug product and device development at Amgen, Thousand Oaks, CA,
, tel. 805.313.6393.

*To whom all correspondence should be addressed.

References

1. N. Rathore and R. Rajan, Biotechnol. Prog., 24 (3), 504–514 (2008).

2. T.A. Barber, Control of Particulate Matter Contamination in Healthcare Manufacturing (CRC Press, 1999).

3. C. Jones, presentation before the PDA Visual Inspection Forum (Bethesda, MD, 2007).

4. J.Z. Knapp and L.R. Abramson, Jrnl. of Parenteral Sci. and Technol., 44 (2), 74–107 (1990).

5. J.Z. Knapp, PDA Jrnl. of Pharma. Sci. and Technol., 75 (2), 131–147 (2007).


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