Updated: Oct 13, 2021
Book Review Vol 26 Issue 3 | Published 13th October 2021
Advances in Practical Safety Ventilation
Pharmaceutical Cleanrooms and Hospital Operating Rooms
Anyone with an interest of ventilation issues will have a great opportunity to learn and understand much more about different applications of safety ventilation after reading this anthology.
This book is a collection of 36 scientific peer-reviewed papers written by Professor Emeritus Bengt Ljungqvist and Assoc. Professor Berit Reinmüller.
The book covers research previously publicized during a period of almost 30 years (from 1991 until 2019) and focus on airborne contamination control in pharmaceutical cleanrooms and hospital operating rooms.
The book is clearly divided into seven sections:
Section 1 – Air movements and dispersion of contaminants
Section 2 – Microbiological environmental monitoring, Measuring equipment
Section 3 – The LR-method and its application
Section 4 – Airflows through openings, Freeze-dryers and autoclaves
Section 5 – Pharmaceutical Blow-Fill-Seal environments
Section 6 – Cleanroom clothing systems
Section 7 – Hospital operating rooms
Some highlights from the book:
The method “Limitation of risks” (LR-method) offers a consistent procedure for evaluating potential microbiological risks of airborne contamination in clean zones in a structured and systematic way. This method is easy to use and consists of three steps – visualize – particle challenge test – calculating the risk factor. By using this approach, the LR-method presents an effective way for the limitation of potential risks. Knowledges from the use of the LR-method are described in section 3.
The behavior of airflow through doorways is an important area to understand when opening e.g. autoclaves and freeze-dryers. To mitigate unwanted airflow patterns by installation of HEPA filter units above the opening to provide clean air and hence protect the opening. Different aspects of this are described in section 4.
In section 5 you will be able to learn more about the airborne particle generation and contaminant dispersion routes within a Blow-Fill-Seal (BFS) machine and hence how to reduce particle concentrations. The BFS technique is used to manufacture e.g. aseptically filled small volume parenteral and therefore it is important to understand the relationship between airborne particle concentrations and the particle concentrations in filled plastic ampoules.
In section 6 the focus is cleanroom clothing systems. How to protect the product and the environment from airborne particles generated from the human skin. Clothing system should be designed to fully cover a person and the clothing itself needs to be tested with regards to material properties such as particle generation, particle filtration and robustness to resist damage.
I would highly recommend this book. It can be used for educational purposes as well as a reference for practical applications.
Each paper is richly illustrated with graphs, equations and pictures which gives the reader a broader understanding of the topics and how to use the knowledge in an applied way.
During my years as a Chief Pharmaceutical Inspector at the Medical Products Agency in Sweden, I saw numerous examples in the pharmaceutical industry across the globe of uncertainty and lack of understanding of ventilation issues. It is my sincere hope that this book will bring back the interest and willingness to understand safety ventilation as an important barrier to achieve the airborne contamination control quality required during pharmaceutical manufacturing as well as to accomplish the cleanliness needed in hospital operating rooms.
Tor Gråberg, M.Sc. Pharm.
Head of Operations Quality Compliance and External Affairs, AstraZeneca
former Head of the Drug inspectorate, Medical Products Agency, Sweden