Contamination Control in Medical Devices, Pharmaceutical & Biotechnology Manufacturing Operations

Process and Product Contamination Investigations

Chemical, particulate, and biological (bioburden) contamination events are frequently associated with plant shutdowns and product recalls. Problems can result from mechanical failures, contaminated raw materials (BPI), materials deterioration, design defects, or improper SOP instructions. Exponent scientists and engineers have extensive experience in contamination investigations: when needed, a multidisciplinary team can be deployed to identify the point source(s) of contamination and develop effective remedial recommendations. Our staff works closely with client facilities engineers, QA/QC professionals, and production staff to investigate process and product contamination events. We are familiar with the relevant cGMP’s and can conduct confidential audits to ensure that client SOPs are properly developed and implemented. The professionals at Exponent often work in complex regulatory environments, and have carried out significant projects in North America, Europe, and Asia.

Compendial Water System Contamination Investigations

Biological contamination of compendial water systems continues to present significant challenges to the pharmaceutical, biotechnology, and medical device industries. Bacteria, in particular, are well adapted to survival in purified water systems. Their presence leads to the contamination of process equipment, raw materials, and in some cases, product adulteration leading to recalls. Effective control of bioburden in compendial water systems requires an understanding of those factors that promote microbial growth and biofilm formation. The presence of biofilms associated with wetted surfaces gives rise to both bioburden and associated endotoxin (pyrogen) contamination. While increased assimilable organic concentrations are often associated with bioburden development, the role of surface topography, materials of construction, and fluid hydraulics in microbial attachment are less well understood. Exponent scientists and engineers have extensive experience in characterizing issues of bioburden (and other contaminants), reviewing system designs, and developing targeted preventive and treatment strategies.

Multidisciplinary Approach

Our professional team includes: Microbiologists, Toxicologists, Materials Engineers, Biomedical Engineers, Building Technology Specialists, Civil/Structural Engineers, Corrosion Engineers, Environmental Engineers, Epidemiologists, and Physicians.

Exponent professionals have the breadth of experience and access to necessary resources to assess the risk of process/product contamination, and develop targeted remedial strategies. Exponent takes a multidisciplinary approach to problem solving, incorporating the expertise of microbiologists, materials scientists, and a variety of professionals from different scientific and engineering disciplines. For every project there is a project manager who is the lead scientist/engineer, and that manager may bring in other experts on an “as needed” basis as required by the issues involved and the budget. Our staff has experience directing contamination and process failure investigations for a wide variety of industries.

Professionals

Knowledge