Evaluation of Steam Sterilization Processes: Comparing Calculations Using Temperature Data and Biointegrator Reduction Data and Calculation of Theoretical …

L Gunnel - PDA Journal of Pharmaceutical Science and …, 2007 - journal.pda.org
When calculating of the physical F 121.1° C-value by the equation F 121.1° C= t· 10 T°
121.1/z the temperature (T), in combination with the z-value, influences the F 121.1° C-value …

Optimization of moist heat sterilization

J Mannermaa, J Yliruusi - PDA Journal of Pharmaceutical Science …, 1993 - journal.pda.org
The use of different combinations of sterilization time and temperature in a pilot scale
autoclave, GEV 612 AR-2 (Getinge Ab, Sweden), in optimizing the sterilization process was …

Discussion of the Z-value to use in calculating the F0-value for high-temperature sterilization processes

IJ Pflug - PDA Journal of Pharmaceutical Science and …, 1996 - journal.pda.org
The appropriate z-value to use in integrating heat process time-temperature data in the
temperature range of 120.0–140.0° C (248.0–284.0° F) is discussed. We conclude that for …

Microbiological aspects of heat sterilization of medicines: II. A method for the determination of the effectiveness of a sterilization process using the bioburden and the …

FA Boom, ACA Paalman, A Stout-Zonneveld - Pharmaceutisch Weekblad, 1984 - Springer
In order to verify whether the sterilization process of 60 min at 100° C for invert sugar 20% is
sufficiently effective to attain the generally accepted probability of survival of maximum 1× …

A method of increasing test range and accuracy of bioindicators: Geobacillus stearothermophilus spores

G Lundahl - PDA Journal of Pharmaceutical Science and …, 2003 - journal.pda.org
Spores of Geobacillus stearothermophilus are very sensitive to changes in temperature.
When validating sterilizing processes, the most common bioindicator (BI) is spores of …

Flexible loading pattern approach in overkill steam sterilization based on the physical properties of steam and thermodynamics of sterilization

A Ben-David - PDA Journal of Pharmaceutical Science and …, 2023 - journal.pda.org
Because overkill steam sterilization processes in autoclaves are considered critical, they are
highly scrutinized, and the use of autoclaves in fixed loading patterns is a common approach …

Temperature dependence of F‐, D‐ and z‐values used in steam sterilization processes

J Van Doornmalen, K Kopinga - Journal of applied microbiology, 2009 - academic.oup.com
Aims: To develop a model, based on microbiological principles, to safely optimize steam
sterilization processes. Methods and Results: The minimum exposure time F for a …

A method for calculating thermal sterilization conditions based upon process parametrics

RA Nash - PDA Journal of Pharmaceutical Science and …, 1985 - journal.pda.org
Process parametric release is widely accepted as an alternative to end-product biologic
sterility testing of injectable products. Based upon 12D overkill conditions (which according …

Steam sterilization in autoclaves

P DeSantis - Handbook of Validation in Pharmaceutical Processes …, 2021 - taylorfrancis.com
This chapter provides a basis for understanding sterilization using moist heat and the
sterilizers employed. It focuses on parts, components, and other items that need to be …

[CITATION][C] F-0-concept in steam sterilisation and the connected sterilisation safety

M Pfeiffer - PHARMAZEUTISCHE INDUSTRIE, 2001 - ECV-EDITIO CANTOR VERLAG …