To All, I feel this topic very important. This reply is not intended as a solicitation, rather to share and check the experience I have gained. I agree with Robert on most points totally. In my experience, instrument stability is a direct result of instrument maintenance. A higher level of maintenance will give a more stable instrument. Like Robert, I suspect from the operation description given by Russ, many instruments are not operating at optimum levels and a few are probably not even operating at acceptable levels, but what can you say, FACScomp passed anyway. In my opinion, A good QA procedure should include both an instrument control and an assay control as well as concerns for flow rates and CV's at a minimum. Concerning the issue of calibration. According to GMP(Good Manufacturing Practices), when using the term calibration in the US, one should understand the implication that a standard exists which is traceable to NIST. Such is the case with size, weight or electronic standards, etc.. For example, when we have our test equipment, scales & thermometers, etc. calibrated they are compared to a standard which is traceable to NIST. A report and a sticker are provided to indicate and verify such traceability. To my knowledge, no traceable standard exists for fluorescence emissions. MESF values can be helpful, but not traceable to NIST. >From a regulatory stand point, how can we calibrate a flow cytometer when no traceable standard exists to compare readings to? Technically, I believe we can't. Perhaps "Correlation" would be a more accurate description. Questions / comments invited. Best regards, Tony Leger Automation Lab Technology altservice@direcway.com 1-360-983-8690 -- No virus found in this outgoing message. Checked by AVG Anti-Virus. Version: 7.0.323 / Virus Database: 267.8.11/44 - Release Date: 7/8/2005Received on Wed Jul 13 13:38:01 2005
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