Biomedical Engineering Reference
In-Depth Information
TABLE 11.1 Hazard Analysis Chart Example
Hazard Analysis Chart
Microbiological Control for Tablet Compression in Non-Sterile Manufacturing
(1)
(2)
(3)
(4)
(5)
Process
Microbial
Justification for
Preventive
CCP
Step
Hazard? (Y/N)
Decision in (2)
Measures
Y/N
1.0 Inspection of
module
No
Step occurs before
cleaning
N/A
No
2.0 Tablet press
cleaned and
assembled
Yes
If microbial quality of
water used for
cleaning is poor
Purified grade water
used for cleaning,
tested on daily
basis before use
to meet microbial
limits
Ye s
3.0 Bring in active
blend and
osmotic blend
No
Product is not
exposed to the
environment
Dispensing
containers are
sealed
No
4.0 Open container
and use drum
inverter to
charge mill
Yes
Product open to
environment
Room air is HEPA
filtered. Operators
are properly
gowned
No
4.1 Turn on
equipment with
heated air for 30
min and
visually check
for dryness
Yes
If tablet press is
stored wet
Equipment is
alarmed when air
reaches 300
◦
Fto
start 30 min
drying step. SOPs
are in place and
operators have
been trained to
verify dryness
Ye s
4.2 Start up tablet
press
No
Operator does not
have product
contact
N/A
No
5.0 Take samples
of tablet at
machine chute
during start-up
using gloved
hands
Yes
If gloves are not
clean, dry, and
fully covered hand
SOPs are in place
operators trained
in proper
gowning and
sampling
techniques
No
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