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U.S. Department of Health and Human Services

Science & Research

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Volume IV - 2.12 Cosmetic Analysis

DFS Pyramid Logo

Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-02
VERSION NO.: 1.7

Section 2 - Microbiology

EFFECTIVE DATE:
10-01-03
REVISED:
08-25-14

A.  Objective

  1. To gain theoretical knowledge of cosmetic microbiology.
  1. To analyze cosmetic products for microorganisms that may cause injury to consumers, including pathogenic bacteria and yeast and mold (e.g. bacterial contamination of eye cosmetics).
  1. To familiarize analysts with the yeast and mold count.
  1. To familiarize analysts with preservative systems employed in multiple use eye area cosmetics.
  1. To familiarize analysts with Gram negative, non-fermenter identification.
  1. To familiarize analysts with opportunistic pathogens present in eye area cosmetics.

B.  Assignment

It is the trainer’s primary responsibility to transfer knowledge both practical and in theory related to sample analysis. This may be accomplished through a series of designated training samples. Once the trainer is confident that the trainee can successfully and independently perform the analysis, the trainee will be issued a series of training samples.

Read Bacteriological Analytical Manual (BAM) chapter, online at:
http://www.cfsan.fda.gov/~ebam/bam-23.html

  1. Test at least 10 sub samples of liquid baby lotion or shampoo. Trainer should spike subs with Pseudomonas, other Gram negative rods, Gram positive rods and cocci, and yeast.
  1. Test at least 10 sub samples of eye area cosmetic (e.g. face powder, eye shadow, mascara). Trainer should spike subs with Pseudomonas, other Gram negative rods, Gram positive rods and cocci, and yeast.
  1. Identify a Gram negative non-fermenting rod, using test kits and biochemicals.

C.  Questions

  1. Describe the sample preparation techniques for liquids and semi powders; solids and powders; preparations with petroleum base; aerosols of powders and liquids; and aerosols of soaps and other foamy liquids.
  1. What is the purpose of dilutions and other added ingredients?
  1. How do Pseudomonas and Klebsiella differ biochemically?  What characteristics clearly separate them?
  1. If, biochemically, a culture was indicated to be Pseudomonas but it did not  produce a fluorescent yellow or blue pigment, would a microbiologist still consider the culture as Pseudomonas?  Explain.
  1. Which organisms are considered pathogenic in the eye area? On the skin?