Steam Sterilization-in-Place

J Agalloco - Handbook of Validation in Pharmaceutical Processes …, 2021 - taylorfrancis.com
Sterilization In Place (SIP) is a process that adapts sterilization methods used for items
placed in fixed chambers to large pieces of equipment alone or assembled into process …

Factors involved in cycle development of a steam-in-place system

D Berman, T Myers, S Chrai - PDA Journal of Pharmaceutical …, 1986 - journal.pda.org
A cycle was developed for an automated in-place steam sterilization process of a large
volume batch (LVB) sterile holding tank assembled with product and tank vent filters and …

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 …

Temperature profiles and sterilization within a dead-ended tube

JH Young, BL Ferko - PDA Journal of Pharmaceutical Science and …, 1992 - journal.pda.org
Use of steam-in-place (SIP) sterilization has increased as the complexity of biotechnology
processing equipment has increased. Extensive biological testing is required prior to use of …

[HTML][HTML] Understanding overkill sterilization: an end to the confusion

JP Agalloco - Pharmaceutical Technology, 2007 - pharmtech.com
The author clarifies the definition and objectives of overkill sterilization for steam sterilization
cycles. Current sterilization practices are reviewed and the validation difficulties associated …

[PDF][PDF] Steam sterilization principles

M Dion, W Parker - Pharmaceutical engineering, 2013 - ispe.gr.jp
Steam sterilization has been used for more than a century to sterilize items that can
withstand moisture and high temperature. Steam is water in the vapor state; therefore, it is …

Validation of the steam-ln-place sterilization of disc filter housings and membranes

SJ Kovary, JP Agalloco, BM Gordon - PDA Journal of …, 1983 - journal.pda.org
Steam-in-place (SIP) sterilization of manufacturing equipment has emerged as an
improvement over systems requiring aseptic connections. Validation of a SIP sterilization …

Design considerations for development of steam in-place sterilization processes

T Myers, S Chrai - PDA Journal of Pharmaceutical Science and …, 1981 - journal.pda.org
A process is described for the steam in-place sterilization of a closed system sterile holding
tank assembled with product and vent filtration equipment. This process permits complete …

[PDF][PDF] An overview of the validation approach for moist heat sterilization, part II

BM Boca, E Pretorius, R Gochin… - Pharmaceutical …, 2002 - researchgate.net
This article illustrates a qualification–validation strategy for moist heat sterilization and briefly
discusses the sterility concept and common sterilization principles. In Part II, the authors …

Parameters governing steam sterilization of deadlegs

JH Young, BL Ferko, RP Gaber - PDA Journal of Pharmaceutical …, 1994 - journal.pda.org
Use of saturated steam for sterilization-in-place (SIP) is limited by factors effecting
displacement of air from deadlegs. Effects of tube diameter, length, orientation and position …