Monographs/White Papers

Monographs

These monographs are designed to answer specific questions for the pharmaceutical, medical device and OTC industries. Monographs are provided only with an associated 30 minutes of consulting time to ensure that all participants have an opportunity to fully explore topics of interest.

Be sure to check out the white papers (below) before purchasing the monograph. The white paper selection may have enough information to answer your questions – the monographs are provided for more detailed evaluation of the topic.

Please be sure to check back frequently as new monographs will be added on a regular basis.

• Investigation of Microbiological Data Deviations

White Papers

These papers are presented in service to the microbiology community of the pharmaceutical, personal products and medical device industries.

Lab Operations

• Quality Control of Microbiological Media
• Gram Staining
• Measurement of Cell Concentration in Suspension by Optical Density
• How to Determine if an Organism is “Objectionable”
• Counting Colonies
• Streaking for Single Colonies: An Essential First Step in Microbial Identification
• USP <1117> Microbiological Best Laboratory Practices
• Microbial Recovery Studies – 50% or 70%?

Testing Considerations

• The Harmonization of the Microbial Limits Test – Enumeration
• The Harmonization of the Microbial Limits Test – Absence of Specified Organisms
• Microbial Limits Tests: The Difference Between “Absence of Objectionable Microorganisms” and “Absence of Specified Microorganisms”
• How Do You Decide Which Microbial Identification System is Best?

Manufacturing Support

• Microbiology in the Contamination Control Plan
• Microbiological Considerations in Stability Programs
• Qualification of an Environmental Monitoring Program – 1. Selection/Justification of Sample Sites