Biomedical Engineering Reference
In-Depth Information
Appendix C-IV-A. Exceptions
The following categories are not exempt from the NIH Guidelines: (i)
experiments described in Section III-A which require Institutional
Biosafety Committee approval, RAC review, and NIH Director
approval before initiation, (ii) experiments described in Section
III-B which require NIH/OBA and Institutional Biosafety
Committee approval before initiation, (iii) experiments involv-
ing DNA from Risk Groups 3, 4, or restricted organisms (see
Appendix B,
Classification of Human Etiologic Agents on the Basis
of Hazard
, and Sections V-G and V-L,
Footnotes and References of
Sections I through IV
) or cells known to be infected with these
agents may be conducted under containment conditions specified
in Section III-D-2 with prior Institutional Biosafety Committee
review and approval, (iv) large-scale experiments (e.g., more
than 10 liters of culture), and (v) experiments involving the delib-
erate cloning of genes coding for the biosynthesis of molecules
toxic for vertebrates (see Appendix F,
Containment Conditions for
Cloning of Genes Coding for the Biosynthesis of Molecules Toxic for
Vertebrates
).
In addition to those exemptions, the NIH distinguishes laboratory use from
Good Large-Scale Practice (GLSP); the latter applies to manufacturers and
makes exceptions from various compliances required in a laboratory.
In summary, in the United States, mammalian cells used for the produc-
tion of recombinant proteins normally require BL1 level in laboratory and
a GLSP level at large-scale commercial production, which means there are
special containment or decontamination requirements and disposable bio-
reactors can be discarded along with other solid waste. When using bacte-
ria, this may not be the case and usual procedures for biodecontamination
would apply unless they fall under IIIC exemption category. Since most of
the future products are likely to be produced in CHO cells such as the mAbs,
it makes the cost of disposing of disposal components easily affordable.
However, discarding in this case would involve either incinerating them
or taking them to a landfill as they are less likely to be recycled, according to
the general consensus of the industry, though there is no clear reason why
this is so. The recycling processes are extremely invasive and should remove
any contaminants.
Those components that are readily recyclable are classified into the follow-
ing categories:
Grade A = Recyclable plastic. Pure fractions of identified plastics.
Examples: Preparation bags, cell culture bags, hold bags, cartridge
bodies, single tubing, tank liners, and packaging material. Currently,
grade A wastes constitute a small percentage, less than 10% of a
