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

Consulting with Scott Sutton