Biomedical Engineering Reference
In-Depth Information
While most manufacturers will use nearly the total contents from a
package containing a particular adhesive, there are normally residual amounts
of the chemical left behind in the package. Thus, appropriate waste disposal
methods are required and based upon local, regional, and federal standards and
guidelines. Some countries will allow for the empty packaging to be dealt with
just as a benign solid waste while others have more stringent controls and
management in place. Since the majority of adhesives dry in the solid or paste
form, there are little regulations aimed at controlling environmental releases to
the air or water. The exception occurs for some adhesives which release
fugitive emissions into the plant. In some cases, mixtures of adhesives are
required to realize the necessary bonding effect. A few nations have
regulations aimed at alleviating any issues resulting from the mixing of these
chemicals and forming, in essence, a new chemical in the process. These
regulations put manufacturing time and quantity limits and special
handling/control requirements on the toxic substances produced in this matter.
EH&S
AND
C
OATING
A
PPLICATIONS
Fluoropolymers, urethane-based, and polyimide laminates are the most
common coatings applied in the biomedical device industry. Depending on the
actual coating techniques used, significant concentrations of aerosols can be
generated in the employee's breathing zone. Like most adhesives, the majority
of coatings used in large quantities in biomedical device manufacturing are
polymer-based; thus, many of the environmental health and safety concerns
are common in scope and severity. All developed nations have some
occupational exposure limit to airborne particulate, typically both at the
respirable size level and for total concentrations. One of the significant
concerns associated with employee exposures to coatings is allergic reactions.
In addition, since metal oxides are used as pigments to provide color to various
coatings, significant inhalation of aerosols can potentially lead to chronic
illnesses such as various forms of cancer (e.g., lung, blood, GI-tract, etc.).
The environmental regulatory issues encountered are very similar to those
associated with adhesives. Empty packages or containers with residual
amounts of the product must be dealt with appropriately by the manufacturer.
However, the levels of regulatory scrutiny that exists in this area vary
somewhat significantly form country-to-country. Many of the real issues
involving both coatings and adhesives is realized in the production of the raw
materials used to make either the coating or adhesive. Thus, the suppliers of
