Evaluation of the Decimal Reduction Time of a Sterilization Process in Pharmaceutical Production

Jeffrey Eisele, Amy Racine and Mauro Gasparini
Additional contact information
Jeffrey Eisele: Novartis Pharma AG, Department of Biostatistics
Amy Racine: Novartis Pharma AG, Department of Biostatistics
Mauro Gasparini: Politecnico di Torino, Dipartimento di Matematica

Chapter 18 in Applied Statistics in the Pharmaceutical Industry, 2001, pp 457-474 from Springer

Abstract: Abstract Consider measuring the effectiveness of sterilization during the production of a pharmaceutical substance. The decimal reduction time, D-value, of a steriliza­tion process is defined to be the time required to reduce the number of microor­ganisms present by a factor of 10. Because the issue of concern is the rate of bacterial death this process is often referred to as “Death Kinetics.” Different methods for sterilization are possible depending on the nature of the pharmaceu­tical product, for example, heat treatment. Since the D-value depends to a large extent on environmental conditions, it is necessary to determine experimentally the substance specific D-value for each substance that is sterilized by means of moist heat. If the D-value of the substance is the same as that of a reference substance, typically water, the sterilization process is deemed successful.

Keywords: Test Substance; Microbial Count; Sterilization Process; ASCII File; Individual Assay (search for similar items in EconPapers)
Date: 2001
References: Add references at CitEc
Citations:

There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-1-4757-3466-9_18

Ordering information: This item can be ordered from
http://www.springer.com/9781475734669

DOI: 10.1007/978-1-4757-3466-9_18

Access Statistics for this chapter

More chapters in Springer Books from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().