I have come across a situation on which I would like the perspective of a
wider audience.
There is a company (supplier/vendor) that produces a biological raw
material for another company (customer). It is an ascites, harvested from
mice. The hybridoma cells that are injected into the mice are grown up in a
General Lab space from a working cell bank. The room air in the General Lab
is not HEPA filtered. All manipulation of cell lines is conducted in a
hood/biological safety cabinet (BSC). The BSC is certified regularly, every
year. The supplier relies on surface disinfection (mostly 70% alcohol,
occasionally phenolic) and UV lights when BSC work zone/area is not in use
to control potential biological contamination. The disinfectants were
qualified, but that was more than 5 years ago. There is no current data on
native or challenge organisms.
Should this general lab space be classified?
Should the BSC work zone be classified?
Should any part of this operation be monitored as part of a routine
Environmental Monitoring Program, whether it is classified or not, for:
1] Non-Viable Particulates?
2] Viable Particulates (air sampling)?
3] Surface Sampling, viables (RODAC, swabs or sponges)?
Thanks for your input,
Tod Ransdell, MIV
Bio-Rad Laboratories
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