Biomedical Engineering Reference
In-Depth Information
regulatory control and specified disposal procedures. It is difficult to image a
research and testing laboratory without a fume hood requiring a stack to the
outside and drums/containers of waste solid/liquids that are not allowed to be
mixed in with the regular refuse. Figure 6 depicts the way hazardous waste in
typically accumulated in a designated area on the facility site prior to shipping.
S
UMMARY
The preceding paragraphs provided information on the environmental
health and safety regulatory aspects of biomedical device manufacturing
typically encountered throughout the world. The major manufacturing
processes and/or activities found in the industry were broken down into eight
distinct classifications. The major human health and safety concerns along
with the germane environmental pollutant issues were elucidated for each of
these categories. Table 1 provides a summary of these processes/activities, the
major stressors identified, and the prevailing EH&S regulatory concerns for
most biomedical device manufacturers.
Table 1. Biomedical Device Manufacturing Process/Activity, Stressor,
and EHandS Concerns
Manufacturing Process or
Activity
Significant Human Health and
Environmental Stressor(s)
Major EHandS Regulatory
Concerns
Sterilization
Ethylene oxide, gamma rays,
electron beam radiation
Occupational, radioactive
materials, transportation
Cleaning, etching, and
surface preparation
Acids, alkalis, alcohols,
acetone, particulate matter
Occupational, air pollution,
liquid/sludge, transportation
Adhesive application
Urethanes, superglues,
acrylics, epoxies, silicones
Occupational, solid and
hazardous waste
Coating application
Fluoropolymers, urethane-
based, polyimide laminates
Occupational, solid and
hazardous waste
Drilling, grinding,
cutting, and other
machining
Oil- and water-based cutting
oils, particulate matter
Occupational, minor air and
sludge waste
Welding and soldering
Metal fumes, particulate
matter, fluorides
Occupational, minor air
pollution
General maintenance
activities
Particulate matter, various
chemicals, noise, heat
Occupational, minor air and
solid/hazardous waste
Laboratory research and
testing
Various biological, chemical,
and physical stressors
Occupational, minor
environmental (all media)
