The Institute for Cellular Transplantation possesses a recently constructed 1000 sq. ft, FDA-registered, self-contained, certified ISO 14644 Class 7 clean room facility (Figure 1) that routinely passes at an ISO Class 5 (Class 100) clean room level. The space was designed to meet the demands of investigators whose activities in translational research require compliance with current Good Manufacturing or Good Tissue Practice (cGMP or cGTP) regulations. Procedure rooms are class 10,000, positive pressure, laminar flow, temperature-regulated clean rooms designed for human tissue processing and equipped for cell separation, purification, culture, and cryopreservation. Under the direction of Dr. Klearchos Papas, the MRB GMP Facility has conducted a series of 22 successful human research islet isolations as of May 2019.
Standard Operating Procedures - Table of Contents
Dr. Klearchos Papas
GMP Facility Director
kkpapas@surgery.arizona.edu
Partial List of Equipment
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(3) Thermo Scientific Bio Safety Cabinet - model 1460 for culturing cells - Image
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Perfusion apparatus PER-5.2-115
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Zeiss Lumar V12 Stereo Microscope - Image
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Zeiss Invertoskop 40C Microscope - Image
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Thermalert TH-5 temperature monitoring system - Image
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Ismatec BVP peristaltic pump - Image
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MasterFlex L/S peristaltic pump – model J15003878 - Image
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(2) Thermo Revco Refrigerator - model RPR1204A21, REC7504A19 - Image
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(2) Thermo Revco -20C Freezer - model UEN2320A19, UFP5030A19 - Image
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NorLake Roll-in Refrigerator
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(4) Thermo Hera Cell 150 CO2 Incubator - Image
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Cole Parmer Polystat Water bath - Image
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Cole Parmer Isotemp 4100 Heated Water bath - Image
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(2) Denver Instrument analytical balances – model PI-4002
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Stryker Neptune 2 Rover fluid waste management - Image
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Terumo BCT COBE 2991 Cell Processor - Image