Review ArticleReview
A Tale of Two Sterilizers
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 162-169; DOI: https://doi.org/10.5731/pdajpst.2019.009993
James P. Agalloco
Agalloco & Associates Inc., 22 Carriage Trail, Belle Mead, NJ 08502

References
- 1.↵
- Garvey W.
- 2.↵
- Matthews B. R.
- 3.↵
- Sutton S. V. W.,
- Tirumalai R.
- 4.↵U.S. Pharmacopeial Convention. General Chapter <1229> Sterilization of Compendial Articles. In USP 36—NF 31; USP: Rockville, MD, 2013.
- 5.U.S. Pharmacopeial Convention. General Chapter <1229.2> Moist Heat Sterilization of Aqueous Liquids. In USP 36—NF 31; USP: Rockville, MD, 2013.
- 6.U.S. Pharmacopeial Convention. General Chapter <1229.1> Sterilization by Direct Contact. In USP 36—NF 31; USP: Rockville, MD, 2013.
- 7.International Society for Pharmaceutical Engineering. Good Practice Guide: Commissioning & Qualification of Pharma Water & Steam Systems; ISPE: Tampa, FL, 2011.
- 8.International Organization for Standardization. ISO 17665: Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. ISO: Geneva, 2006.
- 9.
- Agalloco J.
- 10.
- Agalloco J.
- 11.
- Pavell A.,
- Hughes K.
- 12.U.S. Food and Drug Administration. 21 CFR Part 212—Current Good Manufacturing Practices in Manufacturing, Processing, Packing or Holding of Large Volume Parenterals, and Request for Comments regarding Small Volume Parenterals. U.S. Department of Health and Human Services. Government Publishing Office: Washington, DC, 1976.
- 13.
- Agalloco J.
- 14.
- Agalloco J.
- 15.U.K. Department of Health and Social Services. Health Technical Memorandum 10 Sterilization. DHSS: London, 1980.
- 16.U.K. Department of Health and Social Services. Health Technical Memorandum 2010 Sterilization. DHSS: London, 1994.
- 17.↵Centers for Disease Control and Prevention. Biosafety in Microbiological and Biomedical Laboratories, 5th ed., CDC, 2007.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 1
January/February 2020
A Tale of Two Sterilizers
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 162-169; DOI: 10.5731/pdajpst.2019.009993
Jump to section
Related Articles
- No related articles found.