ABSTRACT

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies

chapter 1|9 pages

An introduction to advanced aseptic processing technology

ByJames Agalloco, James Akers

chapter 3|12 pages

Aseptic processing facility design

BySterling Kline

chapter 4|8 pages

Innovations in aseptic processing technology

ByJames Agalloco, James Akers

chapter 5|7 pages

Ergonomics in enclosure design

ByBrian Smith, David Pallister

chapter 6|22 pages

Design and engineering—containment applications

ByBrian Smith, David Pallister

chapter 7|11 pages

Design and engineering of isolators

ByDidier Meyer

chapter 8|4 pages

Definition of restricted access barrier systems

ByJo¨rg Zimmermann

chapter 10|15 pages

Aseptic processing transfer systems

ByGary Partington

chapter 12|26 pages

A comparison of capital and operating costs for aseptic manufacturing facilities

ByJorge Ferreira, Beth Holden, Jeff Kraft, Kevin Schreier

chapter 13|8 pages

Risk assessment and mitigation in aseptic processing

ByJames Agalloco, James Akers

chapter 14|20 pages

Sterile product manufacture using form fill seal technologies

ByHarold Baseman

chapter 15|9 pages

Genesis of the closed vial technology

ByDaniel Py, Angela Turner

chapter 16|17 pages

Aseptic containment

ByJulian Wilkins

chapter 17|6 pages

Points to consider in the design of a filling isolator

ByValerie Welter

chapter 18|19 pages

Sterility test isolators—a user’s perspective

ByRobert J. Keller

chapter 20|17 pages

Process simulation for advanced aseptic processing

ByJames Agalloco, James Akers

chapter 22|8 pages

Isolator integrity leak inspection

ByScott Pool

chapter 23|9 pages

Environmental monitoring of advanced aseptic processing technology

ByJames Akers, James Agalloco

chapter 24|13 pages

Decontamination of advanced aseptic processing environments

ByJames Agalloco, James Akers

chapter 25|20 pages

Hydrogen peroxide gas decontamination

ByJames R. Rickloff

chapter 26|20 pages

Isolation technology: hydrogen peroxide decontamination

ByDavid Watling

chapter 27|10 pages

Single-injection vapor-phase hydrogen peroxide decontamination of isolators and clean rooms

ByKunihiro Imai, Souma Watanabe, Yasusuke Oshima, Mamoru Kokubo, James Akers

chapter 28|11 pages

Chlorine dioxide decontamination/sterilization

ByMark A. Czarneski

chapter 29|10 pages

Current expectations for aseptic processing: a regulatory perspective

ByRichard L. Friedman

chapter 31|9 pages

A perspective on European regulations for advanced aseptic processing

ByJames Agalloco, James Akers

chapter 32|12 pages

Advanced aseptic processing technologies in Japan

ByTsuguo Sasaki, Morihiko Takeda

chapter 34|9 pages

Highly automated isolator-based vaccine filling—a case study

ByJames Akers, Kazuhito Tanimoto, Masahito Kawata

chapter 36|5 pages

Radiopharmaceutical filling line

ByFrank Mastromonica, Simon Steingart

chapter 38|9 pages

Isolator technology for aseptic filling of anti-cancer drugs

ByPaul Martin

chapter 39|6 pages

RABS case study

ByJo¨rg Zimmermann

chapter 41|8 pages

Isolated robotics

ByChristopher Procyshyn

chapter 42|5 pages

The future of aseptic processing

ByJames Agalloco, James Akers