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Aseptic and Sterile Processing:

TERILE Control, Compliance and
AND S
Tidswell
Sandle

PTIC
ASE
PROCES
SING Future Trends
Control, Compliance and Future Trends

CE
MPLIAN Edited by: Tim Sandle and
Aseptic and Sterile Processing

ONTROL, CO
C S
AND F
U TURE T
REND
Edward C. Tidswell
PDA MEMBER PRICE: $260 $221
PDA NON-MEMBER PRICE: $325 $276.25
HARDCOVER: ITEM NO. 17342
y
Edited b C. Tidswell

Tim San
dle and Edwar
d DIGITAL: ITEM NO. 18038

The Aseptic and Sterile Processing: Control, Compliance and Future Trends is the most important text discussing
aseptic and sterile manufacturing that has been published in the last decade! This text looks at both today and
tomorrow in regard to these two vital processing procedures.
The Editors of this book realized that there was an urgent imperative for these subjects to be reassessed and
represented. To achieve this objective, along with many subject matter experts, they produced a book that is
designed for those involved with aseptic and sterile processing to take away many learning points and apply these
principles to aseptic and sterile processing, within the pharmaceutical and healthcare sectors.
It is the aim of the Editors to help readers reassess legacy definitions and historical understandings and move them
toward concepts that will help them think in new ways about equipment and processes in order to reach the highest
standards and evaluate them through science-based risk assessments.

Table of Contents:
Sterility Aseptic Process Simulations/Media Fills
Contamination Risks and the Patient Cleaning and Sanitization for Aseptic Processing
Current, Ideal and Anticipated Regulations for Cleanroom Gowning
Sterile Drug Products The Sterility Test
Aseptic Processing Risk Assessment and Mitigation in Aseptic
Bioburden Control Processing
Aseptic Processing Filtration The Misattribution of Human Error in Producing
Microbial and Endotoxin Control of Water Systems Sterile Products

Depyrogenation, Nonpyrogenation and Evaluation and Improvement of Aseptic Processes

Repyrogenation Single-Use (Disposable) Technology
Microbial Contamination Control in Cleanrooms The Role of Rapid Microbiological Methods in
Environmental Control and Environmental Aseptic Processing
Monitoring in Support of Aseptic Processing

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