Article CommentaryCommentary
Wanted: Dead or Alive
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 458-464; DOI: https://doi.org/10.5731/pdajpst.2020.011478
James P. Agalloco
Agalloco & Associates Inc., 22 Carriage Trail, Belle Mead, NJ 08502

References
- 1.↵U.S. Pharmacopeial Convention. General Chapter <1229> Sterilization. In USP 42—NF 37, USP: Rockville, MD, 2013.
- 2.↵
- Agalloco J.
- 3.↵
- Pflug I. J.
- 4.↵International Organization for Standardization, ISO 18472:2018 Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment. ISO: Geneva, 2018.
- 5.↵Council of Europe. Methods of Preparation of Sterile Products, Chapter 5.1.1. In European Pharmacopoeia (Ph. Eur.), Council of Europe: Strasbourg, 2008; p 575.
- 6.↵
- Agalloco J. P.
- 7.↵
- Agalloco J.
- 8.↵International Organization for Standardization. ISO 11137-2:2013 Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization Dose. ISO: Geneva, 2013.
- 9.↵Association for the Advancement of Medical Instrumentation. AAMI TIR33: Sterilization of Health Care Products—Radiation—Substantiation of a Selected Sterilization Dose—Method VDmax. AAMI: Arlington, VA, 2005; p 54.
- 10.↵U.S. Pharmacopeial Convention. General Chapter <1229.1> Steam Sterilization by Direct Contact. In USP 42—NF 37, USP: Rockville, MD, 2013; p 8079.
- 11.↵U.S. Pharmacopeial Convention. General Chapter <1229.14> Sterilization Cycle Development. In USP 42—NF 37, USP: Rockville, MD, 2017; p 8115.
- 12.↵
- Agalloco J.
- 13.Parenteral Drug Association Inc. Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control; Bethesda, MD, 2007.
- 14.↵
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 5
September/October 2021
Wanted: Dead or Alive
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 458-464; DOI: 10.5731/pdajpst.2020.011478
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