Back to the Top
To All,
Anyone out there have experience/knowledge regarding a more objective
approach to quantifying reconstitution times (in minutes) for a 10 mL
lyo vial of equine gamma globulin protein for the human pharmaceutical
market. The general subjective approach (swirling-visual with
stopwatch) doesn't sit well with the Federal regulators and I would
appreciate some input for developing an instrumental method
independent of subjectivity. How are extended reconstitution times (up
to 30 min.) viewed by the industry ?
All comments/suggestions are welcome - thank you.
R. Stewart
rdstewart51.at.yahoo.com
Back to the Top
The visual approach has been accepted for products that reconstitute quickly
(a few minutes). If the reconsititution time is lengthy (more than a few
minutes) then I would think that there would be questions from regulators and
hospital pharmacists.
As far as an instrumental approach, the only thought that I have is something
like the Eisai Automated Inspection System that is used to inspect parenteral
products for defects (particulate matter). I'm not sure that testing clarity
will work because a single large particle would likely be out of the field of
view before the measurement was made.
Bob Snider
PharmPC Discussion List Archive Index page
David Bourne (david@boomer.org)