Hi,
we are in to blood bag manufacturing (Medical device),bags are terminally sterilized (Validated moist heat method) @115 C with primary packing.
can any one suggest on below statement
“The incubation period for terminally sterilized products is not less than 7 days and 14 days for aseptically filled products as per IP”.
as per IP 2007 this line was coated,but in latest version this line was removed.
if we follow not less the 7 days it will comply to IP?
we would like to move with 7 days. Please share some reference.