reference

Panofen D, Pandolfi D, Denoya C. Compressed gases: an important component of an environmental monitoring programme. 2017;22(4):16-20

Posted: 7 September 2017 | | No comments yet

References

  1. (2013). Microbiological Control and Monitoring of Aseptic Processing Environments. Chapter <1116>. 784-794. Rockville, MD, USA.
  2. Denoya C, Reyes J, Ganatra M, Eshete D. Rapid Sterility Testing using ATP Bioluminescence-based PallChek Rapid Microbiology System. Rapid Sterility Testing (J. Moldenhauer Ed.). 2011. Chapter 17, 433-461, DHI/PDA. Bethesda, MD, USA.
  3. Denoya C. Implementation of Rapid Microbiological Methods: Some Technical Challenges Still Ahead. American Pharmaceutical Review. 2014.Vol. 17, No. 1. (This article is based on a presentation made at the European Microbiology Conference held on 7-8 May 2014 at Prague, Czech Republic).
  4. Gupta R. Role of Environmental Monitoring and Microbiological Testing during Manufacture of Sterile Drugs and Biologics. American Pharmaceutical Review. 2014.
  5. Robert JL. Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Quality Implementation Working Group (Q-IWG). 2010. Washington D.C. USA.
  6. Denoya, C. Microbial Survival in Compressed Gases. 2016. Application Note. Particle Measuring Systems, Boulder, CO, USA. In preparation.
  7. ISO 14698-1. Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods. International Organization for Standardization. 2003. Geneva, Switzerland.

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