Review ArticleReview
Increasing Patient Safety by Closing the Sterile Production Gap—Part 3—Moist Heat Resistance of Bioburden
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology July 2017, 71 (4) 274-278; DOI: https://doi.org/10.5731/pdajpst.2017.007641
James P. Agalloco
Agalloco & Associates Inc., 22 Carriage Trail, Belle Mead, NJ 08502
BE, MS, MBA
Reference
- 1.↵
- Agalloco J.
- 2.↵
- Agalloco J.
- 3.↵
- Sandle T.
- 4.↵
- Agalloco J.,
- Akers J.
- 5.↵FDA. Guideline on Sterile Drug Products Produced by Aseptic Processing, 2004.
- 6.↵EMA. Annex 1, Sterile Medicinal Products, 2008.
- 7.↵USP 36. <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments. In USP 36, 2011.
- 8.↵
- Pflug I.
- 9.↵www.hi-tm.com/RFA/food-path-summ.pdf (accessed 2/1/17).
- 10.↵
- 11.↵
- Stumbo C. R.
- 12.↵PDA. PDA Technical Report 22. Process Simulation for Aseptically Filled Products Revised, 2011.
- 13.↵
- Williams O. B.,
- Zimmerman C. H.
- 14.↵
- Pflug I.
- 15.↵
- Stumbo C. R.
- 16.↵
- Russel A. D.,
- Hugo W. B.,
- Ayliffe G. A.
- Smelt J.,
- Mossel D.
- 17.↵USP. Sterilization <1229>. In USP 39, 2013.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 4
July/August 2017
Increasing Patient Safety by Closing the Sterile Production Gap—Part 3—Moist Heat Resistance of Bioburden
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 274-278; DOI: 10.5731/pdajpst.2017.007641
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