Dead

This technology update discusses deadlegs, the 6D rule, the new 2D rule, and why these rules tell only half the story. After you read this update, you will understand the current industry thinking about dead legs, why it is flawed, and what Biokinetics' position is on the issue. You will also know what the FDA thinks. Most importantly you will understand the science behind the concern about deadlegs and be better equipped to utilize fundamental principles to design process systems that can be effectively cleaned and sterilized at a reasonable price.

Historical Perspective

The 6D RuleDeadlegs first hit the limelight in 1976 when theGuide for Large Volume Parenterals (CFR 212)was circulated for comment. This document,which was never passed into law, contained aparagraph, which became known as the "6D Rule"which stated that no pipe should have "an unusedportion greater in length than six diameters of theunused pipe measured from the axis of the pipe inuse".

This is depicted graphically in Figure 1.

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