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U.S. Department of Health and Human Services

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Volume IV - 2.13 Sterility of Drugs and Medical Devices

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Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-02
VERSION NO.: 1.5

Section 2 - Microbiology

EFFECTIVE DATE:
10-01-03
REVISED:
02-14-13

A. Objective

  1. To analyze drugs and medical devices that are labeled sterile for sterility using analytical techniques, such as membrane filtration and direct inoculation.
  2. To introduce the following concepts: bacteriostatic, fungistatic, particulates, pyrogens, bioburden testing,  preservative effectiveness, moist  and dry heat sterilization, ethylene oxide (ETO) sterilization, gamma sterilization, and aseptic technique.
  3. To present clean room technology and QA.
  4. To present gowning procedure.
  5. To present clean room QA and analytical techniques.
  6. To read and discuss USP sections and supplemental information found in the FDA Sterility Analytical Manual.
  7. To read and discuss sporicidal testing of disinfectants as referenced in AOAC section titled “Disinfectants”, and the FDA standard operating procedure titled, “Testing Sporicidal Activity”.

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.

  1. Analyze a large volume parenteral (LVP) and a small volume parenteral (SVP) for sterility using USP methodology. Trainer should spike one or two units with aerobic and anaerobic organisms.
  2. Analyze two different medical device samples for sterility (WEAC). Trainer should spike a number of units with aerobic and anaerobic organisms.
  3. Trainer will discuss other related tests such as bacterial endotoxins (LAL gel-clot and automated assay), pyrogen, particulate matter, bioburden, and preservative-effectiveness.
  4. Read USP <71> (current  edition).

C. Questions

  1. What is the purpose of the bacteriostatic/fungiostatic test?  What is the inoculation level in CFUs to be used to inoculate product in media?
  2. Describe what is done to ensure the work area is acceptable for sterility testing?
  3. What is a microbiologist to do if the air sample plates grew several different kinds of organisms?
  4. When would the incubation time be extended to 30 days?
  5. What determines if a product is a SVP or LVP?
  6. What is the purpose of using two different media?
  7. How does Fluid Thioglycollate maintain anaerobic conditions?
  8. What is the function of the red indicator in Fluid Thioglycollate?
  9. What is meant by the D value, Z value, F0 value? 
  10. How is a sterility test by membrane filtration different from a sterility test by direct transfer?  A Millipore Steritest system would be used for which of these methods?
  11. What is the difference between Fluid A, D, and K.?  When would a microbiologist use one over the other?