1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com

Course Content:

Contaminant Sources

• Product and Process Related Contaminants
• Adventitious Contaminants

Contaminant Classes

• Physical
• Particles, Fibers
• Chemical
• Byproducts, Leachables, Process and Cleaning Residues
• Biological
• Contaminating Proteins, DNA, Microbes, Viruses, Pyrogens

Setting Specifications for Contaminants in 

• Materials, 
• Components, 
• Equipment, 
• Utilities, and 
• Product

Methods for Detecting Contaminants

• Product and Process Related Contaminants
• Analytical Chromatography Methods, Immunoassays, Electrphoretic Methods
• Residues from Previously Manufactured Product
• Sampling Techniques, Detection and Identification Methods
• Microbes
• Sampling Methods, Sterility Assays, Test-Laboratory Requirements, Species Determination
• Viruses and Mycoplasma
• Sampling, in vitro and in vivo Detection and Identification Methods
• Pyrogens
• Sampling, USP-Rabbit Test, LAL-Test, Cell Culture Assay
• Particulates in Utilities, Environment and Product
• Sampling Methods, Detection and Identification Methods

Strategies for the Manufacture of Contaminant-Free Product

• Controlling Materials, Equipment, Utilities and Environment

Methods for Removing and Inactivating Contaminants

• Product Purification
• Ion Exchange Chromatography
• Hydrophobic Interaction Chromatography
• Metal-Chelate Chromatography
• Affinity Chromatography
• Size Exclusion Chromatography
• RP Chromatography
• Filtration
• "Open" Column Chromatography vs. HPLC
• Virus Inactivation
• CIP, SIP and Depyrogenation of Equipment

Prevention of Contaminant Entry into Product and Process

• Qualification and Testing of Materials and Components
• Design and Validation of Equipment
• Design and Validation of Facility
• Training and Qualification of Personnel

Routine Monitoring for Contaminants

• QC Testing of Materials and Product Purity
• Monitoring of Equipment Cleanliness
• Environmental Monitoring
• Monitoring the Cleanliness and Health of Personnel
• Troubleshooting and Trend Analysis
• Handling of Out-of-Specification Results