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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 7 anything else. The steady progress with sterility- by-design concepts, even if they have never been called that, has rendered viable monitoring largely moot. In the most evolved technologies, monitor- ing is performed more out of custom than for any useful purpose. Sterility cannot be tested into the product Advanced microbiological methods suffer the same sampling, recovery, and enumeration con- straints and their introduction changes nothing. Simply put, quality, or in this instance, "steril- ity", cannot be tested into any product. There is ample empirical evidence, however, that patient safety has increased. The need for and frequency of human inter vention as well as the number of humans working in the asep- tic environment have been diminished by en- gineered improvements to processing systems. Where advanced aseptic processing technol- ogies are used, direct interventions have been eliminated entirely (8). The elimination of di- rect interventions using separative technologies such as isolators has rendered environmental monitoring obsolete, because it does nothing but produce nu l l resu lts day in a nd day out. More sampling only produces more zero recov- ery findings and yet fails to yield any meaning- ful information The best aseptic systems in use today have a lready eliminated t he human operator, and additional improvements in aseptic processing are certain to improve efficiency and reduce the cost of goods produced in the future. However, change will be required if we are to realize the full potential of these advances. Envi- ronmental monitoring has a crucial role in early steps, prior to sterilization, to monitor bioburden and particulate levels. As more advanced aseptic technologies come into use, the role of environ- mental monitoring should be reduced, because it has become a non-value added activity. Testing quality in is never appropriate, especially when that testing might have adverse consequences for the product. References 1. FDA, Guideline on Sterile Drug Products Produced by Aseptic Processing, 2004. 2. EMA, Sterile Medicinal Products, Annex 1 draf t revision, 2017. 3. C. Lok, Nature 522, 270-273 (June 18, 2015) 4. K. Lewis, "The Uncultured Bacteria," Schaecter American Society for Microbiology Blog, July 2010, schacechter.asmblog.org/schaechter/2010/07/ the-uncultured bacteria.html. 5. S. Sutton, Journal of Validation Technology, pp 42-46 (March 2011) 6. B. Ljundvist and B. R heinmuller, PDA Journal of Pharmaceutical Science & Technology, 57 (2), pp. 114-125 (March 2003). 7. J. Agalloco and J. Akers, Pharmaceutical Technology, 34 (3), Supplement, pp. S44-45 (2010). 8. J. Akers, J. Agalloco, J. R. Madsen, Pharmaceutical Manufacturing, 4 (2), pp 25-27 (2006). 9. J. Agalloco, J. Akers, Pharmaceutical Technology, 31 (5), Supplement p. S8-11 (2007). PT Environmental monitoring has a crucial role prior to sterilization, to monitor bioburden and particulate levels. As more advanced aseptic technologies come into use, [its role] should be reduced, because it has become a non-value added activity.