Revision of USP Chapter <1116> on Environmental Monitoring

GMP News No. 604

GMP News
14 September 2005

Revision of USP Chapter <1116>
on Environmental Monitoring

The informal Chapter <1116> of the US-American Pharmacopoeia (USP), "Microbiological Evaluation of Clean Rooms and Other Controlled Environments", is currently being revised - a process that started in spring this year.

The draft of the revision is quite fundamental, which can be seen from the fact that the title was changed to "Microbiological Controls and Monitoring Environments used for the Manufacture of Healthcare Products".

The driving force behind the changes was certainly the replacement of the former cleanroom classes defined in US Federal Standard 209e by ISO Standard 14644. Furthermore, the new state of the art will be taken into account in the revised version.

In the following we have compiled the changes in the titles of the subchapters for you.

  • Establishment of Clean Room Classifications (title unchanged)
  • Importance of a Microbiological Evaluation Program for Controlled Environments (title unchanged)
  • Physical Evaluation of Contamination Control Effectiveness (new subchapter)
  • Training of Personnel (title unchanged)
  • Critical Factors Involved in the Design and Implementation of a Microbiological Environmental Control Program (title unchanged)
  • Establishment of Sampling Plan and Sites (title unchanged)
  • Establishment of Microbiological Alert and Action Levels in Controlled Environments (title changed to "Selection of Sample Sites within Clean Rooms and Aseptic Processing Areas")
  • Microbial Considerations and Action Levels for Controlled Environments (title changed to "Establishment of Microbiological Control Parameters in Clean Rooms and Isolators Used for Aseptic Processing")
  • Methodology and Instrumentation for Quantitation of Viable Airborne Microorganisms (title changed to "Methodology and Instrumentation for Sampling of Airborne Microorganisms")
  • Sample Volumes For Active Air Monitoring (new subchapter)
  • Methodology and Equipment for Sampling of Surfaces for Quantitation of Viable Microbial Contaminations in Controlled Environments (title unchanged)
  • Culture Media and Diluents for Sampling or Quantitation (title changed to "Culture Media and Diluents Used for Sampling")
  • Identification of Microbial Isolates from the Environmental Control Program (title unchanged)
  • Operational Evaluation of the Microbiological Status of Aseptically Filled Products in Clean Rooms and Other Controlled Environments (deleted)
  • An Overview of the Emerging Technologies for Advanced Aseptic Processing (deleted)
  • Conclusion (new subchapter)
  • Glossary (title unchanged)

The scope of changes varies from chapter to chapter. The following areas have undergone considerable extension

  • the suggestions on sampling frequency in aseptic production units
  • the requirements on personnel training
  • advice on monitoring in isolators
At the following events, you will get detailed information about the current requirements on environmental monitoring in aseptic manufacture:

Dr Andreas Mangel
on behalf of ECA

Go back

GMP Conferences by Topics