during media fill by filling media we can only determine bacteria,fungi or yeast.
the concern is how to detect pyrogens and endotoxins if present in the environment??
Pyrogens or Lipopolysachharides are material that come from bacteia. That too gram negetive bacteria from their cell walls. You must qualify during your primamry packing material qualification and material qualification.
You must always ensure that your Water for injection, Raw materials, Active materials, Connectors, Tanks, Primary packing materials are pyrogen free or they fall with in the limits that are specified in the Pharmacopoeia.
These materials should undergo riggerous qualification. During filling there is no chance that they fall from the environment that is present around them as you handle every sterilized material under LAF or Class A environment.
There are a series of qualification procedures.
Once you qualify all these areas you move to media fill.
thank you Durga sir for your quick reply…
The media fill guideline does not mention about pyrogens and endotoxins.
For parenteral preparations you have to take care in manufacturing process to avoid the gram negative bacterial contamination.
Dr.Pradeep Nagalkar