Two-part ISO biocontamination control standard unveiled


GENEVA—Five down, five to go.

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That's how Richard Matthews, chairman of the International Organization for Standardization (ISO) Technical Committee 209 (ISO/TC209), summed up the release of ISO 14698, Cleanrooms and associated controlled environments—Biocontamination control Part 1 and Part 2.

ISO 14698 is the latest addition to a contamination-control creed that includes the four-part ISO 14644 international cleanroom and contamination control standards that ISO/TC 209 has been hammering away at since 1993. “These are the fourth and fifth documents, and we expect between now and at the end of 2004 to have five more documents on molecular containment, separative devices, isolators, minienvironments and hoods, cleanroom operations, test methods and definitions,” Matthews says.

According to ISO, expanded international trade in hygiene-sensitive products, combined with growing restrictions on the use of antimicrobial agents, has created a need for increased bio-contamination control.

ISO 14698 Parts 1 and 2, which have been in use as Draft International Standards since 1999, are the first general International Standards for biocontamination control. Approved as International Standards on June 3, ISO 14698-1 and ISO 14698-2 were published on September 1.

Intended to promote appropriate hygienic practices, “ISO 14698-1, Cleanrooms and associated controlled devices—Biocontamination control—Part 1: General principles and methods” outlines principles and basic methodology for a formal system to assess and control biocontamination when cleanroom technology is applied.

ISO 14698-2, “Cleanrooms and associated controlled devices—Biocontamination control—Part 2: Evaluation and interpretation of biocontamination data” describes methods for evaluating microbiological data and estimating biocontamination data obtained from sampling for viable particles in risk zones. ISO 14698-2 details sampling techniques, time factors, culturing techniques, and analysis methods for initial and routine monitoring.

Designed to be used in concert, parts 1 and 2 of ISO 14698 also go hand-in-hand with the ISO 14644 cleanroom standards. “You can use it to establish a formal system and predict areas of concern, i.e. risk zones,” Matthews says. “There are no specific numbers in these documents. There is nothing that says that you cannot exceed three colony-forming units. This is important, because other than the classes of air cleanliness, nothing else has specifics, meaning you can tailor it to your quality assurance plan.”

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