Required section · Section 6 of 6
What this run does and does not prove
The guided case supports one narrow conclusion: a 3,113-RPM setting on a 12.0 cm radius rotor delivers 1,300 x g, matching the cited BD SST swinging-bucket condition, and the post-run appearance was consistent with adequate processing. It does not prove that every downstream analyte on that serum is stable, because that depends on the validated test procedure, analyzer controls, and specimen acceptability criteria that sit outside the centrifuge itself.
Maximum speed, balance tolerance, fill volume, brake setting, cleaning chemistry, rotor life, and spill wait time are not universal values; they come from the exact equipment manual, the tube manufacturer's instructions, and the laboratory's own risk assessment and validated procedures. For nonwaived testing, function checks such as periodic RPM and timing verification are expected at least as often as the manufacturer specifies, with documentation and acceptable results required before patient testing resumes. Run logs, preventive maintenance, and rotor inspection records are part of the same quality record, not a separate paperwork exercise.
A clean serum or plasma interface, pellet, or sediment is reassuring but is not proof by itself; it supports adequate processing only within a method that has already been validated for that RCF, time, and specimen type. When something is uncertain: rotor identity, balance, adapter fit, or contamination, the defensible action is to stop and resolve it before the run or before releasing anything downstream of it.
RCF, balance, and inspection are upstream controls; they support a good result, they do not replace the validated test procedure that actually produces one.
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