Biocontamination refers to biological contamination of products by bacteria and/or fungi, as well as the toxic by-products of these micro-organisms, such as endotoxin and mycotoxins from Gram-negative bacteria and fungi respectively. When designing a biocontamination control strategy, which is based on the manufacturing process, there are three components to consider, each of which requires risk assessment: 1) designing process systems to avoid contamination; 2) monitoring process systems to detect contamination; and 3) reacting to contamination events with proactive measures. Process systems design is where maximum effort should be placed.
Although often overlooked by some laboratories, the international standard on biocontamination control, ISO 14698, is an important resource for the development of a biocontamination strategy. There are two parts to this standard: Part 1 covers general principles and methods of biocontamination control; Part 2 covers the evaluation and interpretation of biocontamination data. Both parts of ISO 14698 are currently undergoing revision.
It is important to clarify the distinction between ISO 14698 and the cleanroom standard ISO 14644. ISO 14644 is a 12-part cleanroom certificate standard that is focused on airborne particulates. This standard covers cleanroom design, high-efficiency particulate air (HEPA) filter specification, pressures, and how to monitor a cleanroom to assess the cleanroom class. ISO 14698 focuses on the ongoing assessment of cleanrooms for viable contamination.
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