we produced ranithidine syrup but unfortunately the product was contaminated with bacteria.I have a question.
Is the tyndalization method suitable for decontamination the product or Is this work approved by the Food and Drug Administration ? please help me. thanks a lot
Tyndallization method This is a fractional sterilization method .The method was official in B.P.1932,for sterilization of medicaments unstable at 115 degree C but able to withstand low temperature heating .The method was used for sterilization of culture media.
In this method ,the solution to be sterilized is packed and sealed in its final container and heated at 80 degree C for one hour on each of three successive days.The first heating destroys the vegetative cells but not the bacterial spores.These bacterial spores germinate into the vegetative forms in the interval between the first and the second heating and are killed in the second heating .The third heating provides a safeguard against any spores which may not germinate until the second interval.
The method was deleted from the B.P. 1932 by the 4th Addendum (1941) and replaced by “Heating with a Bactericide”.
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thanks alot .
but i dint now Is this work approved by the Food and Drug Administration ? please help me