Disposable Components in Aseptic Processing - Pharmaceutical Technology

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Disposable Components in Aseptic Processing
The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.


Pharmaceutical Technology


Conclusion

Many disposable devices are already available, most commonly as a single entity, but in some instances already connected (e.g, filter–bag or bioreactor–filter systems). Rapidly developing connectivity will enhance the development of connected, integral systems and potentially total disposable processes, at least in small volume scales. Some developments (e.g., filling lines) are still necessary. The last step in aseptic processing has not reached the level one finds in the intermediate steps.

The benefits of disposability within aseptic processes are obvious. Cleaning deficiencies are a common regulatory observation, which would be eliminated by disposable equipment use. The risk of cross contamination is greatly reduced. Moreover, disposable, aseptic connectivity will reduce the level of end-user manipulation within the process and therefore create higher safety. Disposability is also valuable from economic and environmental standpoints because there is a cost savings in cleaning solutions and copious amounts of water, as well as the high energy levels required to heat the cleaning solutions or steam sterilize reusable equipment.

Maik W. Jornitz* is group vice-president of marketing FT/FRT at Sartorius Stedim,
. Jean-Marc Cappia is group vice-president of marketing FMT at Sartorius Stedim SA. Theodore H. Meltzer is principle of Capitola Consultancy.

*To whom all correspondence should be addressed.

Additional reading

  • M.W. Jornitz et al., "Testing for the Optimal Filter Membrane," Genetic Engineering News 24 (13) (July 2004).
  • J. Mora et al., "Disposable Membrane Chromatography: Performance Analysis and Economic Cost Model," BioProcess Int. 4, 38–43 (2006).
  • PDA Technical Report 26: Liquid Sterilizing Filtration (Parenteral Drug Association, Bethesda, MD, 2008).
  • M. Prashad and K. Tarrach "Depth Filtration Aspects for the Clarification of CHO Cell-Derived Biopharmaceutical Feed Streams," FISE 9, 28–30 (2006).
  • P.M. Priebe, "Advances in Fluid Processing Technologies," presented at the PDA SciTech Conference, Orlando, March 2004.
  • M. Rios, "Disposable Filtration Lightens Cleaning and Validation Load," Pharm. Technol. 25 (9), (2003).
  • A. Sinclair and M. Monge, "Quantitative Economic Evaluation of Single Use Disposables in Bioprocessing," Pharma. Eng. 22 (3), 16–20 (May–June 2002).
  • J.X. Zhou and T. Tressel, "Membrane Chromatography as a Robust Purification System for Large-Scale Antibody Production," BioProcess Int. 3, 32–37 (2005).


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