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U.S. Department of Health and Human Services

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Volume IV - 2.15 Establishment Inspections

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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 determine the presence of viable aerobic microorganisms and pathogenic microorganisms in pharmaceuticals, from raw materials to finished product.
  1. To practice aseptic technique when handling isolates.
  1. To introduce the use of Official Monographs from the USP (current edition).
  1. To introduce the following concepts: inhibition, inactivating agents, and neutralization of inhibiting substances.

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 USP<61> (current edition).

  1. Analyze a solid, fluid, water-immiscible fluid (waxes, ointments, cream), and fluid specimen in aerosol form for Total Aerobic Microbial Count, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella, Escherichia coli, Molds, and Yeast Counts or according to specifications of Official Monographs.
  1. Perform preparatory test.

C.  Questions

  1. What are the controls used in this experiment?
  1. What are some ways to neutralize inhibitory substances?
  1. What is Purified Water?
  1. How does someone determine what microbial test to run on products?
  1. What is the preparatory test?