The Evolution of Single-Use Technologies in Aseptic Processing - Pharmaceutical Technology

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The Evolution of Single-Use Technologies in Aseptic Processing
The authors describe the origins of single-use components and explain their application to aseptic processes. They also show how disposable devices have changed over time and offer a glimpse of the future.


Pharmaceutical Technology
Volume 34, Issue 4, pp. 112-117

Conclusion

Many single-use devices already are available, most commonly as individual entities. More and more filter–bag and bioreactor–filter systems have been introduced, and single-use unit operations recently have become available. Components' rapidly developing connectivity will enhance the development of integrated systems and, potentially, totally disposable processes. Some limitations, especially in the filling area still must be overcome (e.g., fill precision). The last step in aseptic processing has not reached the level of disposability that one finds in the intermediate steps.

Single-use components have many benefits within aseptic processes. For example, cleaning deficiencies are a common regulatory observation that would be eliminated by single-use equipment. The equipment also greatly reduces the risk of cross contamination. Moreover, disposable, aseptic connectivity will reduce end-user manipulation within the process and therefore improve safety. Some in the industry have wondered whether the benefits of single-use systems are outweighed by their environmental impact. Further studies and thorough evaluations, however, might show that the environmental impact of cleaning and sterilizing stainless-steel equipment is greater than that of single-use systems. This topic will likely be addressed in the near future.

Maik W. Jornitz* is vice-president of marketing FT/FRT, and Thomas Paust is global director of marketing IS, both at Sartorius Stedim North America, 5 Orville Dr., Bohemia, NY 11716, tel. 631.254.4249,
. Jornitz also is chair of the Parenteral Drug Association.

*To whom all correspondence should be addressed.

References

1. EudraLex, Concerning Medicinal Products for Human and Veterinary Use, Vol. 4, Annex 1, p. 12 (European Union, Brussels, 2008).

2. P.M. Priebe, PDA SciTech Conference (Orlando, FL, 2004).

3. A. Sinclair and M. Monge, Pharm. Eng. 22 (3) 1–9 (2002).

4. M.W. Jornitz et al., Genet. Eng. News 24 (13), 50–51 (2004).

5. PDA, "Liquid Sterilizing Filtration," Technical Report 26 (Parenteral Drug Association, Bethesda, MD, 2008).

6. M. Rios, Pharm. Technol. 27 (9), 46–56 (2003).

7. J. Mora, BioProcess Int. supp. 4, 38–43 (2006).

8. J.X. Zhou and T. Tressel, BioProcess Int. 3 (9), 32–37 (2005).


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