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Under the right
circumstances, validations can often
be completed in only eight weeks. The
diagram below provides an example of
a
typical validation timeline. Our
validation personnel will generate a
custom timeline specific to your
validation. This way, you can
converse with our experts using the
same technical "buzz words" and stay
on top of the projected completion
date.
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A common question is:
how many devices will I need to complete the
validation?
Since the gas
diffusion process uses independent 1.24ft3 sterilization bags/chambers, the number
required for validation depends on the number of
devices that fit into the bag/chamber.
Example: CathMed1 manufactures
balloon-tipped catheters and is need of a full
validation.
The size and density of this product allows each
sterilization bag or flexible chamber to hold
fifty (50) catheters.
Device Numbers Required:
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Four fully-loaded sterilization bags—can be
returned. |
200 |
|
Catheters
for destructive testing—these will not
be returned. |
15 - 50 |
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Catheters or
dummy product (six fully loaded
sterilization bags)—devices that very
closely resemble the actual product in
terms of size, density and composition.
These are required to fill the
sterilizer to capacity—these will be
returned. |
300 |
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Total
number of catheters |
500 |
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