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Complaint conclusion follow up questions
Nov 24, 2025 08:00 PM
Hi Nilay,
The methanol dilutions are done to the drug stock prior to spiking the product. It’s standard for us in production to use the methanol dispenser for these dilutions, We did have to do multiple of these dilutions to get the drug stock to the concentration we needed it before spiking the SMx serum.
I believe the technical term is uncertainty of measurement. The calibration tolerance of this methanol dispenser is not as tight as our pipets are. With doing multiple dilutions, any variation in accuracy of the dispenser is compounded so by switching to using pipets for this process we believe the multiple dilutions will have a lower likelihood of being impacted by this. Let us know if you have any further questions or recommendations.
Thank you,
Andrew Hartmann
Business Development Manager
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From: Nilay Bhavsar <NBhavsar@sonicreferencelab.com>
Sent: Monday, November 24, 2025 1:08 PM
To: Andrew Hartmann <ahartmann@utak.com>; Amber Shultz <AShultz@sonicreferencelab.com>
Cc: Jamie Vreeland <jvreeland@sonicreferencelab.com>
Subject: RE: UTAK QC follow-up
Andrew,
Thank you for your cooperation. I agree with change in the process for the next preparation of QC. Can you provide some insight into what dilutions the methanol dispenser was being used for? Dilutions of stocks from reference materials, SMx dilutions?
Thanks,