Biomedical Engineering Reference
In-Depth Information
• Over pressures
• Double door airlock
• Gowning changes
Risk acceptable
6.
Shared
facility
unsuitable
Animal house
located in same
building
Contamination
of drug
product
Risk mitigated and acceptable.
Risk needs to be monitored
(pressures)
YES
• Door separating animal facility
from general corridor
in
addition to
double door airlock
and overpressures, HEPA
filtration etc. (see earlier text)
for GMP production facility as
well as negative pressure in
animal facility
• Different staff—personnel
working in GMP facility
forbidden to do any animal
work on same day they work in
production
• Doors self-closing
• Access controls enforced at all
times
• Shared equipment e.g.,
dishwasher replaced with
dedicated equipment to mitigate
need for R&D personnel to
access GMP area
(
continued
)
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