Test
Services
VDmax
Validation - TIR 27
VDmax, or TIR 27 method validates a 15 or 25 kGy
minimum sterilization dose. This method is limited
to a maximum bioburden of 1.5 colony-forming units
(CFU) per device for VDmax 15 and 1,000 CFU per
device for VDmax 25 kGy. VDmax requires a low
number of test samples thus reducing costs. VDmax
calculates the highest verification dose possible
for your product, which results in a reduced risk
of failure. A 25.0 kGy minimum sterilization dose
is standard at most irradiation facilities. The
15 kGy VDmax dose method is for sensitive products
that can be successfully sterilized at 15 kGy.
| Test
Code |
Test
Description |
Minimum
Sample Requirements |
Turnaround
time |
| VD-015 |
VDmax Validation 15kGy |
3
lots of 20 units plus 3 units for bioburden
validation and 3 for Bacti Fungi Statis
testing |
30 days |
| VD-025 |
VDmax Validation 25kGy |
30 days |
|
