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Related Experiment Video

Updated: Jul 11, 2026

Isolation of Human Islets from Partially Pancreatectomized Patients
11:10

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Published on: July 30, 2011

Islet isolation under cGMP conditions: replacing the coil.

M R Garfinkel1, M Connors, D Ostrega

  • 1Department of Surgery, The University of Chicago, Chicago, Illinois 60637, USA. mgarfink@surgery.bsd.uchicago.edu

Transplantation Proceedings
|June 15, 2004
PubMed
Summary

A disposable blood warming system effectively replaces metal coils for islet isolation, meeting flow and temperature control needs. This innovation supports current good manufacturing practices (cGMP) compliance for clinical islet transplantation.

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05:21

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Area of Science:

  • Biomedical Engineering
  • Cellular Therapy
  • Transplantation Science

Background:

  • Clinical islet transplantation is increasingly regulated under current good manufacturing practices (cGMP).
  • cGMP mandates validation of equipment cleaning and sterilization.
  • Current automated islet isolation uses a metal coil requiring complex cleaning and sterilization.

Purpose of the Study:

  • To assess a disposable blood warming system as a cGMP-compliant alternative to metal coils.
  • To evaluate the system's flow rate accommodation during pancreatic digestion.
  • To determine the system's heat exchange efficiency and temperature control capabilities.

Main Methods:

  • A pancreas digestion circuit was established using either a metal coil or a disposable Warmflo blood warming bag.
  • Temperature within the digestion chamber was monitored using a thermocouple.
  • Time to reach 37°C and temperature maintenance were recorded at various set temperatures.

Main Results:

  • The disposable blood warming bag accommodated flow rates of 150 and 300 mL/min.
  • The bag achieved 37°C in shorter or equivalent time compared to the metal coil.
  • Temperature maintenance was equivalent, with successful application in four human islet isolations.

Conclusions:

  • A disposable blood warming system offers adequate flow, heat exchange, and temperature control for islet isolation.
  • This system may simplify compliance with current good manufacturing practices (cGMP).
  • Facilitates the advancement of islet isolation processes toward regulatory standards.