Article CommentaryCommentary
Sterility Assurance—Current and Future State
Edward C. Tidswell, James P. Agalloco and Radha Tirumalai
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 263-277; DOI: https://doi.org/10.5731/pdajpst.2020.012526
Edward C. Tidswell
1Merck, West Point, PA 19486;
James P. Agalloco
2Agalloco & Associates Inc., PO Box 899, Belle Mead, NJ 08502-0899; and
Radha Tirumalai
3U.S. Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-1790

References
- 1.↵U.S. Pharmacopeial Convention, General Chapter <1211> Sterility Assurance. In USP 41—NF 36 Supplement 2, USP: Rockville, MD, 2018.
- 2.↵
- Sandle T.,
- Tidswell E. C.
- Hussong D.
- 3.↵General Medical Council. Tests for Sterility. In British Pharmacopoeia, 1932; pp 632–633.
- 4.↵
- 5.↵
- Moldenhauer J.,
- Sutton S. V. W.
- 6.↵U.S. Pharmacopeial Convention, General Chapter <71> Sterility Tests. In USP 41—NF 36 Supplement 2, USP: Rockville, MD, 2018.
- 7.↵U.S. Pharmacopeial Convention, General Chapter <1222> Terminally Sterilized Pharmaceutical Products—Parametric Release. In USP 27—NF 22 Supplement 1, USP: Rockville, MD, 2004.
- 8.↵
- Eglovitch J.
- 9.↵
- 10.↵European Medicines Agency, Guideline on the Sterilization of the Medicinal Product, Active Substance, Excipient and Primary Container (Draft). EMA: London, 2016.
- 11.↵USP <1071> Rapid Sterility Testing of Short-Life Products—A Risk Based Approach. Pharmacopeial Forum 2018, 44 (5).
- 12.↵
- Cundell A. M.
- 13.↵
- Drennan M. R.
- 14.↵
- Hayes R. J.
- 15.↵U.S. Food and Drug Administration, 21 CFR Part 211.165(b). U.S. Department of Health and Human Services. Government Publishing Office: Washington, DC.
- 16.↵U.S. Food and Drug Administration, 21 CFR Part 200.50 and 51. U.S. Department of Health and Human Services. Government Publishing Office: Washington, DC.
- 17.↵U.S. Food and Drug Administration, 21 CFR Part 211.165(a). U.S. Department of Health and Human Services. Government Publishing Office: Washington, DC.
- 18.↵U.S. Food and Drug Administration, 21 CFR Part 211. 167(a). U.S. Department of Health and Human Services. Government Publishing Office: Washington, DC.
- 19.↵U.S. Food and Drug Administration, Guidance for Industry: Submission of Documentation of Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2010.
- 20.↵U.S. Food and Drug Administration, 21 CFR Part 212—Current Good Manufacturing Practice for Positron Emission Tomography Drugs. U.S. Department of Health and Human Services. Government Publishing Office: Washington, DC.
- 21.↵U.S. Food and Drug Administration, 21 CFR Part 800—Medical Devices—Current Good Manufacturing Practice (CGMP). U.S. Department of Health and Human Services. Government Publishing Office: Washington, DC.
- 22.↵
- Stevens-Riley M.
- 23.↵
- Tirumalai R.,
- Porter D.
- 24.↵
- Sandle T.,
- Tidswell E. C.
- Tidswell E. C.,
- Bennett S. E.
- 25.↵
- Vartoukian S. R.,
- Palmer R. M.,
- Wade W. G.
- 26.↵
- 27.↵
- Norris J. R.,
- Ribbons D. W.
- Postgate J. R.
- 28.↵
- Barer M. R.,
- Harwood C. R.
- 29.↵
- Kell D. B.,
- Young M.
- 30.↵
- 31.↵
- Mollah A. H.,
- Long M.,
- Baseman H. S.
- Tidswell E. C.
- 32.↵U.S. Pharmacopeial Convention, General Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments, In USP 29—NF 24, USP: Rockville, MD, 2010
- 33.↵Pharmaceutical Quality Research Institute. PQRI Aseptic Processing Working Group—Final Report—2002. www.pqri.org/wp-content/uploads/2015/12/finalreport.pdf (accessed February 16, 2022).
- 34.↵Parenteral Drug Association Inc, 2017 PDA Aseptic Processing Survey; Bethesda, MA, 2017.
- 35.↵
- Agalloco J.,
- Akers J.
- 36.↵U.S. Food and Drug Administration, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2004.
- 37.↵European Medicines Agency, Annex 1: Manufacture of Sterile Medicinal Products (draft revision). EMA: London, 2020.
- 38.↵U.S. Pharmacopeial Convention, General Chapter <1211> Sterilization and Sterility Assurance of Compendial Articles. In USP 21—NF 16, USP: Rockville, MD, 1985, pp. 1347-1352.
- 39.↵U.S. Pharmacopeial Convention, General Chapter <1229> Sterilization of Compendial Articles. In USP 29—NF 34, USP: Rockville, MD, 2013.
- 40.↵European Medicines Agency, Guideline on the Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container. EMA: London, 2019.
- 41.↵
- Agalloco J. P.
- 42.↵
- 43.↵
- Block S. S.
- Pflug I. J.,
- Holcomb R. G.
- 44.↵
- Russell A. D.,
- Hugo W. B.,
- Ayliffe G. A. J.
- Russell A. D.
- 45.↵
- Russell A. D.,
- Hugo W. B.,
- Ayliffe G. A. J.
- Gould G. W.
- 46.↵
- Lingnau J.
- 47.↵International Organization for Standardization, ISO 11137–1: 2006 Sterilization of Health Care Products—Radiation—Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Device. ISO: Geneva, 2006.
- 48.↵
- 49.↵
- 50.↵
- Agalloco J. P.,
- Akers J.,
- Madsen R.
- 51.↵
- Tidswell E. C.,
- McGarvey B.
- 52.↵
- Tidswell E. C.,
- McGarvey B.
- 53.↵
- Morrissey R. F.,
- Bruch C. W.,
- Sharbaugh R. J.,
- Favero M. S.,
- Jarvis W. R.,
- Masefield J.
- 54.↵
- Mosely G. A.
- 55.↵
- von Woedtke T.,
- Kramer A.
- 56.↵
- Agalloco J.,
- Tidswell E. C.
- 57.↵
- Agalloco J. P.
- 58.↵
- Agalloco J. P.
- 59.↵
- Agalloco J. P.
- 60.↵International Organization for Standardization, ISO 15882:2008/(R)2013. Sterilization of Health Care Products—Chemical Indicators—Guidance for Selection, Use and Interpretation of Result. ISO: Geneva, 2013.
- 61.↵
- Sutton S.
- 62.↵
- Sandle T.,
- Tidswell E. C.
- Tidswell E. C.
- 63.↵ICH Quality Guideline Q10: Pharmaceutical Quality System. ICH Web site. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf (accessed February 16, 2022).
- 64.↵ICH Quality Guideline Q11: Development and Manufacture of Drug Substance (Chemical Entities and Biotechnological/Biological Entities). ICH Web site. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf (accessed February 16, 2022).
- 65.↵ICH Quality Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Draft). ICH Web site. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Draft_Guideline_Step2_2017_1116.pdf (accessed February 16, 2022).
- 66.↵
- Stauffer R.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 3
May/June 2022
Sterility Assurance—Current and Future State
Edward C. Tidswell, James P. Agalloco, Radha Tirumalai
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 263-277; DOI: 10.5731/pdajpst.2020.012526
Jump to section
- Article
- Abstract
- Introduction
- Sterility Assurance—Current State
- Current US Legislation Governing Sterility and Sterility Testing
- Testing Sterility
- Sterility Assurance—Evolution of a New Perspective
- Sterility Assurance–Future State
- Principles Governing Parametric Release
- 1. Quantification of Assurance of Sterility
- 2. Process Parameters and Critical Process Parameters
- 3. Risk Assessment and Microbial Control Strategy
- Summary
- Conflict of Interest Declaration
- References
- Figures & Data
- References
- Info & Metrics
Related Articles
- No related articles found.
Cited By...
- No citing articles found.