Biomedical Engineering Reference
In-Depth Information
the establishment of disease in healthy people, plants, or animals; or (ii) in
uncontrolled proliferation of any microbiological agents or eukaryotic cells.
Appendix K-VII-F. Disinfection. Disinfection is a process by which viable
microbiological agents or eukaryotic cells are reduced to a level unlikely to
produce disease in healthy people, plants, or animals.
Appendix K-VII-G. Good Large-Scale Practice Organism. For an organ-
ism to qualify for Good Large-Scale Practice consideration, it must meet
the following criteria [Reference: Organization for Economic Cooperation
and Development,
Recombinant DNA Safety Considerations
, 1987, p. 34-35]:
(i) the host organism should be nonpathogenic, should not contain adven-
titious agents and should have an extended history of safe large-scale use
or have built-in environmental limitations that permit optimum growth in
the large-scale setting but limited survival without adverse consequences
in the environment; (ii) the recombinant DNA-engineered organism should
be non-pathogenic, should be as safe in the large-scale setting as the host
organism, and without adverse consequences in the environment; and (iii)
the vector/insert should be well characterized and free from known harmful
sequences; should be limited in size as much as possible to the DNA required
to perform the intended function; should not increase the stability of the con-
struct in the environment unless that is a requirement of the intended func-
tion; should be poorly mobilizable; and should not transfer any resistance
markers to microorganisms unknown to acquire them naturally if such an
acquisition could compromise the use of a drug to control disease agents in
human or veterinary medicine or agriculture.
Appendix K-VII-H. Inactivation. Inactivation is any process that destroys the
ability of a specific microbiological agent or eukaryotic cell to self-replicate.
Appendix K-VII-I. Incidental Release. An incidental release is the discharge
of a microbiological agent or eukaryotic cell from a containment system that
is expected when the system is appropriately designed and properly oper-
ated and maintained.
Appendix K-VII-J. Minimization. Minimization is the design and opera-
tion of containment systems in order that any incidental release is a de mini-
mis release.
Appendix K-VII-K. Pathogen. A pathogen is any microbiological agent
or eukaryotic cell containing sufficient genetic information, which upon
expression of such information, is capable of producing disease in healthy
people, plants, or animals.
Appendix K-VII-L. Physical Barrier. A physical barrier is considered any
equipment, facilities, or devices (e.g., fermentors, factories, filters, thermal
oxidizers), which are designed to achieve containment.
Appendix K-VII-M. Release. Release is the discharge of a microbiological
agent or eukaryotic cell from a containment system. Discharges can be inci-
dental or accidental. Incidental releases are de minimis in nature; accidental
releases may be de minimis in nature.
