Nephrectomy from a Living Donor
Parameter Study Criteria for donation Renal function 99m Tc-DTPA scintigraphy GFR >80 mL/min/1.73 m2 and GFR >5th percentile for their age Proteinuria Spot urine (U) protein, albumin, creatinine U protein/U…
Standard Multiorgan Procurement from the Deceased Donor
Fig. 1.1 Donor incision in the midline from the sternal notch to the pubis, with a cruciate extension at the level of the umbilicus Fig. 1.2 The abdominal flaps are…
Total Pancreatectomy and Islet Autotransplantation
Fig. 9.1 The lesser sac is entered by dividing the greater omentum between the stomach and the transverse colon. The short gastric vessels are ligated and divided (dashed black line)…
Donation After Cardiac Death Organ Procurement and Transplantation
Fig. 2.1 Cholangiogram depicting ischemic cholangiopathy in a donation after cardiac death (DCD) liver transplant Of note, some single-center experiences with controlled-DCD liver transplants reveal excellent outcomes, comparable to DBD…
Pharmaceutical Industry Profile
1 Pharmaceutical Industry Profile Andrew A. Signore CONTENTS Industry Overview: Introduction Outsourcing Contract Development and Manufacturing Supply Chain Logistics and Security Risk Management Strategic Environmental Forces Political Forces Social Forces…
Sterile Manufacturing Facilities
11 Sterile Manufacturing Facilities George Wiker CONTENTS Introduction Executive Summary Injectable Products Understanding the Principles of Sterile and Aseptic Sterile Manufacturing Facilities Process Technologies Drug Product Processing Primary Drug Product…
Biotechnology Facilities
12 Biotechnology Facilities David M. Marks, PE CONTENTS Introduction Executive Summary Overview Historical Context Key Concepts and Principles Definitions Biotechnology Facility Design Production Systems Bioprocess Manufacturing Operations Equipment Cleaning and…
Occupational Health and Safety
15 Occupational Health and Safety George Petroka CIH, CSP CONTENTS Introduction Occupational Health and Safety Management Accident Prevention Signs and Tags Accident Prevention Signs Accident Prevention Tags Combustible Dust Review…
Continuous Oral Solid Dose Processing
10 Continuous Oral Solid DoseProcessing Michael Rooney CONTENTS Introduction Executive Summary Overview of Continuous Granulation Batch Processing Technologies and Improvements Continuous Granulation Continuous Granulation versus Batch Processing Equipment Requirements Facility…
Sustainability
16 Sustainability Asif Syed CONTENTS Introduction Issues in Sustainability Air Quality and Emissions Environment Release of Products Water Solid Waste Energy Sustainable and High-Performance Facilities Integrated Product Design Sustainable Assessment…
