Biomedical Engineering Reference
In-Depth Information
TABLE 11.2 CCP Decision Chart Example
CCP Decision Chart
Microbiological Control for Tablet Compression in Non-Sterile Manufacturing
Process Step-Hazard
Q1 Q2 Q3 Q4 Q5 CCP
Notes
4.0 Open container and use drum
inverter to charge mill
Yes Yes No No N/A No
None
4.1 Turn on equipment with heated air
for 30 min and visually check for
dryness
Ye s Ye s Ye s N/A N/A
Ye s
Non e
Product:
Date:
Signature(s):
For process step 4.1, the answer to question 1.0, is there a hazard, is recorded
as “Yes.” Moisture trapped in the equipment could help support the growth of
microorganisms. If the answer to question 1.0 is “Yes,” the step could be a
CCP and question 2.0 is addressed. The answer to question 2.0, do preventive
measures exist, is recorded as “Yes.” A drying step and a check for dryness
are preventive measures taken to control the moisture in the equipment. If the
answer to question 2.0 is “Yes,” then the step could be a CCP and question 3.0
is addressed. The answer to question 3.0, is the step(s) specifically designed to
eliminate the likely occurrence of the hazard, is recorded as “Yes.” Drying the
equipment and ensuring it is dry are steps specifically designed to eliminate the
occurrence of moisture that would support microbial growth. If the answer to
question 3.0 is “Yes,” the step is a CCP and the decision process is complete.
“N/A” is recorded for questions 4.0 and 5.0 and “Yes” is recorded in the CCP
column.
On the basis of the responses to the decision tree analyses, the process step
of opening the container and using the drum inverter to charge the mill is not
considered to be a CCP, whereas the process step of turning on the equipment
with heated air for 30 min to dry the equipment is a CCP. Controlling the moisture
in the process will control the potential growth of microbial contamination.
If a hazard has been identified at a step where no control exists but control
is necessary for product safety, then the process should be modified to include a
control measure.
11.3.4.9 Principle 3: Establish Critical Levels at each CCP
Critical levels
must be specified and validated if possible for each CCP. The team ensured
that critical levels were established for preventive measures associated with
each identified CCP and served as the boundaries for each CCP. Levels are
associated with a measurable factor, e.g., time, temperature, pH, moisture level,
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