Bioburden

Bioburden is the population of viable microorganisms on or in product located within a sterile barrier system. Knowledge of bioburden population is important for a variety of applications, including but not limited to the following:

  • Sterilization process validation
  • Monitoring the manufacturing environment and/or raw materials used in the manufacture of product
  • Assessment of cleaning processes
  • As part of an overall environmental monitoring program.

Measuring bioburden involves a number of extraction and culturing procedures designed to provide knowledge of the number and characterization of the population of microorganisms on or in the product. The extent of characterization is dependent on how the bioburden data is to be used. iuvo has extensive experience evaluating bioburden from various medical device and pharmaceutical products utilizing diverse extraction procedures (mechanical removal, sonication, swabbing and other custom methods) and differential plating for aerobes, spores, fungi and anaerobes.

Further characterization of the bioburden is possible with selective growth media, gram staining, and identification to the species level. iuvo is able to comply with various compendial procedures and international standards (such as ISO 11737-1), as well as specific customer supplied procedures.

Tests

Water Testing – Heterotrophic Plate Count

Membrane – 4 Categories

Membrane – 3 Categories

Membrane – 2 Categories

Membrane – 1 Category

ISO 11737-1-1995 – Pour Plate – 4 Categories

ISO 11737-1-1995 – Pour Plate – 3 Categories

ISO 11737-1-1995 – Pour Plate – 2 Categories

Bioburden Recovery – Multiple Extraction Method

Bioburden Recovery – Innoculation Method