The Compendial Draft Chapter on “Bioburden Control of Nonsterile Drug Substances and Products”

USP Chapter 1115 Pharm Forum 39(4) July/August 2013.

Scott Sutton, Ph.D.
Microbiology Network, Inc.


The long-awaited USP draft of a newly proposed chapter – <1115> Bioburden Control of Nonsterile Drug Substances and Products” has been released in Pharmacopeial Forum of July/August, 2013.   This chapter describes a risk-based approach to monitor and control of the manufacturing facility and process for non-sterile drugs.
The chapter’s introduction provides a brief description of the goals of the chapter (primarily to present a risk-based approach to non-sterile microbial control) and provides a hierarchy of non-sterile product categories from this perspective.   From there, a description of relevant sections in 21 CFR 211 are presented, with commentary.
Moving on from existing guidance, microbial control considerations during manufacturing are considered with descriptions of different routes of microbial introduction into non-sterile products. This section is fairly extensive, and provides a useful figure to help visualize the relationships.

The next topics developed are the two themes of control and monitoring.  On the control side, areas discussed include:

  • Equipment design and use
  • Personnel
  • Manufacturing Environment
  • Active measures for microbial control

The discussion of microbial monitoring for non-sterile production focuses on environmental monitoring including some information on selection of EM sampling sites and frequency of sampling.  There is some discussion of alternate microbiological methods and their usefulness in EM programs as well.  The draft chapter concludes with a discussion of the management of the microbiological control program for Nonsterile manufacturers.   This discussion heavily emphasizes the need for risk analysis and an understanding of the product, the materials (especially water), the facility and the patient population in a coordinated risk analysis program.
This draft is open for comments – these comments are important as USP informational chapters have a strong regulatory affect and this is the best opportunity to comment on the chapter.   Download a copy for review either from USP PF  or download a copy here.

More information on this chapter is available in the recorded webinar provided by the author.



This posting, and the associated webinar, are not necessarily representative of the policies or positions of USP.  The author is presenting these as his personal opinions and review, and they are not meant to provide any representation of any organization or group.

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