Biomedical Engineering Reference
In-Depth Information
TABLE 6.3
Initial Risk Prioritization and Rationale
Risk #
(Priority)
Identified Risk
Proposed Controls
Rationale
1.
Microbial
contamination
Facility classification,
equipment design
and disinfection;
personnel: gowning
and training;
materials
specifications and
handling
procedures
Microbial contamination
risk increased because
target population
immunocompromised
2.
Analytical
methods
Select a more
sensitive method to
ensure accurate
quantitiation and
identification
Excipient known to
interact and affect
specificity of method
3.
Stability
Switch from
securitainer to
blister pack
Product sensitive to
moisture
4.
API sensitive to
moisture
Use (existing) glove
box with humidity
control and
production facility
with humidity
microenvironment
Small quantities but
moisture sensitive
5.
Cross-
contamination
Existing controls will
suffice
This product poses no
special risk—toxicity
profile known, low
potency
• temperature;
• mixing speed; and
• reaction time.
If these were placed in a matrix with a potential high range, low range, and mid
range (levels) for each of the parameters, the matrix would look like Table 6.4.
In a full factorial design, that is, where each of the six factors is tested at two
levels (low and high) leaving out the mid range, there would be 2
6
experiments
required
=
128 experiments needed. Design of experiment software (commer-
cially available and inexpensive) allows a partial factorial design to be used
where, with prior knowledge (e.g., reactant 2 is present in excess, such that
this cannot be a factor affecting the success of the process), fewer than half
of the experiments are needed and information can be gained not only for the
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