Affygility Solutions is pleased to present our next book review on Containment in the Pharmaceutical Industry, edited by James P. Wood. Containment in the Pharmaceutical Industry is part of the Drugs and the Pharmaceutical Sciences series of textbooks and monographs. This book is not a single author, but actually a collection of chapters each authored by either a single or pair of authors. As with any book written in this manner, maintaining a consistent tone and emphasis is a challenge, but it does offer the benefit of different approaches and areas of expertise from each of the authors.
Chapter 1: Why Contain? Then and Now is written by the Editor and provides the definition of containment, a brief history of containment in the pharmaceutical industry, the business case for containment, and environmental considerations. The section on “The Business Case” is a good start, but much more should be written on this topic. In my experience, many environmental, health and safety professionals need a lot of assistance in the use of cost avoidance/payback analysis. Tools such as ROSI (Return on Safety Investment) can be very valuable in performing this analysis. In regards to potent compound safety and containment, much more needs to be written on this topic of making the business case. Maybe I’ll discuss this in future postings. If you would like to contribute to this topic, let me know.
Chapter 2: Containment and Good Manufacturing Practices is written by M.J. Crichton of Eli Lilly and Company. This chapter provides a basic introduction to GMPs and frequently references the ISPE Baseline Guides. It discusses the Baseline Guide’s principles for bulk pharmaceutical chemicals, oral solid dosage facilities, and sterile manufacturing facilities. It begins to introduce the some basic concepts of barrier isolation of potent compounds.
Chapter 3: Industrial Hygiene Aspects of Pharmaceutical Manufacturing is written by Donna Heidel, formerly of Johnson and Johnson, now with NIOSH. Ms. Heidel does a good job of introducing some basic industrial hygiene concepts regarding occupational exposure to potent compounds including inhalation, dermal absorption, and ingestion. She also introduces a discussion on occupational exposure limits for pharmaceuticals and how they are calculated. Industrial hygiene sampling for pharmaceuticals is discussed, as well as a short, but very valuable, section on the limitations to the OEL/SAMPLE/RETROFIT APPROACH TO MANAGING EXPOSURES. The section on performance-based occupational exposure limits (PB-OEL) is concise and well presented with a good discussion on potent compound categorization and control banding. This chapter should be a must read for any industrial hygienist or EH&S professional entering the biotechnology or pharmaceutical industry.
Chapters 4, 5, and 6 discuss particle characteristics, particle monitoring, and particle monitoring case studies. These chapters are very technical in nature with lots of diagrams, charts, and equations. Good information for engineers, but too much material to discuss in this brief review.
Chapter 7: Selecting the Correct Technology and Chapter 8: Engineered Local Exhaust are good chapters, with Chapter 8 providing lots of possible solutions for different unit operations.
Chapter 9: Flexible Containment for Primary Manufacturing/Bulk Operations is one of few sources of formal literature on this topic. If you’re considering flexible containment you should read this chapter.
Chapter 10: An Array of Containment Designs is written by the Editor, and discusses that for a compound with a “stringent” occupational exposure limit (OEL) that you will need to have a collection of containment methods and devices. In this chapter the editor describes containment solutions through a solid-dose manufacturing process from dispensing to bulk tablet loading.
Chapter 11: Containment System Selection discusses the process of matching up potent compound to the proper control banding strategies. It’s a good chapter since it present considerations such as physical form, operator interface and duration, quantity, and hazards of the materials.
Chapter 12: An Architectural/Engineering Firm’s Perspective presents information on how to approach determining containment requirements for new facilities or remodeling of existing facilities. Good chapter for a construction management team to review.
Chapter 13: Containment in the Hospital Setting was a little bit of surprise for me that this information was included in this book. This chapter is only 5 pages long and seems out of place for this book. Good basic information, but could have easily been published elsewhere.
The one area that the book lacks is a thorough discussion on containment validation. Throughout the book is does briefly touch on personal exposure monitoring, but a more detail discussion on containment validation and surrogate monitoring is needed.
In summary, the book is 245 pages long so it doesn’t take up much shelf space in your library. Would I recommend it? Depends on who’s buying it. It is fairly pricey, but most books that are this specialized tend to be so. If your company is buying it, I’m sure it will get read and be a good addition to your potent compound safety resource library.
If you have any questions or need additional information, please contact us at Affygility Solutions.