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Policies & Standard Operating Procedures
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IIDP Policies and Procedures
Minimal IIDP Criteria for Accepting Human Cadaveric Pancreata for Islet Isolation
Precautions
The 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings
IIDP Protocols
SHP-002 Flash Freezing Unclaimed Islets
SHP-002 Flash Freezing Unclaimed Islets
Attachment 1
-Supply List
Attachment 2
-Flash Frozen Log Sheet
SHP-003 Standardized International Shipping Documentation
SHP-003 Standardized International Shipping Documentation
Attachment 1
-Fedex Shipping Label
Attachment 2
-Commercial Invoice
Attachment 3
-Declaration of Biological Shipments (Fillable)
Attachment 4
-Commercial Invoice (Fillable)
SHP-004 Culture and Preparation for Cold Shipping
SHP-004 Culture and Preparation for Cold Shipping
Attachment 1
-Ciprofloxacin Stock Preparation
SHP-005 Cold Shipping of Human Islets
SHP-005 Cold Shipping of Human Islets
SHP-006 Cold Shipping of Fresh Non-Islet Pancreatic (Acinar)Tissue
SHP-006 Cold Shipping of Fresh Non-Islet Pancreatic (Acinar)Tissue
Attachment 1
-Tips for Efficiency in Packaging
Attachment 2
-TipTemp Handling Instructions
Attachment 3
-Ciprofloxacin Stock Preparation
Attachment 4
-Trypsin Stock Preparation
SHP-007 Cold Shipping of Flash Frozen Non-Islet Pancreatic (Acinar)Tissue
SHP-007 Cold Shipping of Flash Frozen Non-Islet Pancreatic (Acinar)Tissue
Attachment 1
-Ciprofloxacin Stock Preparation
Attachment 2
-Trypsin Stock Preparation
QA-001 Qualitative & Quantitative Assessment of Human Purified Islets for Distribution Using Dithizone (DTZ)
QA-001 Qualitative & Quantitative Assessment of Human Purified Islets for Distribution Using Dithizone (DTZ)
QA-002 Viability Estimation of Islets for Distribution Using Inclusion and Exclusion Fluorescent Dyes (FDA/PI)
QA-002 Viability Estimation of Islets for Distribution Using Inclusion and Exclusion Fluorescent Dyes (FDA/PI)
Attachment 1
-Preparation Fluorecein Diacetate and Propidium Iodide Solutions
QA-003 Microbiology Testing for Islets for Distribution
QA-003 Microbiology Testing for Islets for Distribution
Attachment 1
-Microbiology Tracking Worksheet
QA-004 Sentinel Flask Preparation
QA-004 Sentinel Flask Preparation
QA-005 Potency Test: Glucose Stimulated Insulin Release Assay
QA-005 Potency Test: Glucose Stimulated Insulin Release Assay
QA 006 Uploading of Digital Image of Count Sample
QA-006 Acquisition and Uploading of Digital Image of Count Sample for Broadcast
QA 007 Preparing Pancreas Section for Histology
QA-007 Preparing Pancreas Section for Histology
Attachment 1
-Histology Log Sheet
Attachment 2
-FedEx Reimbursement Invoice Template
IIDP Center Islet Isolation Protocols
Scharp Lacy Institute
Advances in Human Islet Processing: Manufacturing Steps to Achieve Predictable Islet Outcomes from Research Pancreases
Southern California Islet Cell Resource Center
National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
Erratum. National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 2016;65:3418-3428
University of Miami
National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
Erratum. National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 2016;65:3418-3428
University of Pennsylvania
National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
Erratum. National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 2016;65:3418-3428
University of Wisconsin
National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
Erratum. National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 2016;65:3418-3428