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Effectively Leveraging Technology to Improve Environmental Monitoring of Aseptic Processing

M. Goetter
Moda Technology, US

Keywords:
environmental monitoring, aseptic processing

Abstract:
FDA 2004 Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing and the Code of Federal Regulation governing the manufacture of pharmaceutical products (21 CFR 211) both state the need to establish and follow procedures to prevent microbiological contamination of sterile drug products. Industry experts contend that although today’s environmental monitoring (EM) programs are more costly and time-consuming than those of 15 years ago; there is no evidence that they are functionally superior. This session presents a case study of how a biopharmaceutical company is leveraging wireless technology to improve the efficiency of their EM program while significantly reducing costs.

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