Book description
The first one-volume guide to sources of contamination in
pharmaceuticals and medical devices
Most books dealing with contaminants in medicinal products often
focus on analytical methods for detecting nonspecific impurities. Key
to the work of the pharmaceutical chemist, this unique reference helps
identify the sources of contamination in medicinal and pharmaceutical
products and medical devices. Divided into three parts, Sources of
Contamination in Medicinal Products and Medical Devices covers
chemical, microbiological, and physical (particulate matter)
contamination, including those originating from sterilization procedures.
As compelling as a medical documentary, the book sheds light on how
impurities and contaminants can enter the human body transported via a
specific product or treatment. Focusing on only those medicinal
products and medical devices that may lead to exposure to contaminants
harmful to human health, the book offers a comprehensive, systematic
look at the entire universe of medical contamination:
- Chemical contaminants including residual solvents, catalyst
residuals, and genotoxic impurities in active pharmaceutical
ingredients (APIs)
- Diagnostic imaging agents (i. e., radiopharmaceuticals and
contrast agents)
- Microbiological and endotoxin contamination involving single and
multiple dose products, medical devices, and biofilms
- Contamination from sterilization procedures, residuals from
radiation sterilization, ionizing radiation on packaging materials
and medical devices
- Medicinal gases and volatile anesthetics
- Biopharmaceuticals including recombinant DNA technology products
- Extractables and leachables from containers made of glass,
plastics, and metal
Each section of the book contains information on what contaminants
could be expected in a particular product, and how they were generated
and reached that product. With up-to-date regulatory guidelines for
determining contamination, as well as methods for assessing,
quantifying, avoiding and removing contaminants, Sources of
Contamination in Medicinal Products and Medical Devices is
essential to fully understanding the specific threats that undermine
the safety of medicines and medical devices.
DENISE BOHRER, PhD, is Professor of Analytical Chemistry at the
Federal University of Santa Maria, Brazil. Her research has focused on
sources of contamination in pharmaceutical products, specifically,
infusion solutions for patients with kidney disease and preterm
infants. She has published sixty-eight papers and two book chapters on
pharmaceutical manufacturing.
