Media simulation trials for aseptically filled products

[@pharmigmicrobiology2456]

Very useful introductory video

[@Victoriawakeup]

Tim i know the 14 day dual incubation is industry standard. Is this referenced anywhere?

[@majdiayoub2500]

Thans Mr.Tim for valued presentation: I have a question please: if media fill was done for eye drop with non-transparent bottle, then how we can detect the turbidity or growth at this stage?

[@timsandlemicrobiologist]

Hello, you need to switch to using an identical transparent bottle for the simulation.

[@majdiayoub2500]

@@timsandlemicrobiologist thanks a lot Mr.Sandle for your reply …. On the other hand , I have still two question. That being as debate with my client, and your reply will be added value for me : 1- is there need for separate sterile testing lab for Blow fill seal solution Manufacurering plant ( IV bag with sodium chloride )? 2- is there need for gowning as Class A for BFS room ( operator ) or not ?! Also, is there need for separation gowning and degowning rooms for blow fill seal room in case class A Gown used ? Thanks and appreciate ur effort

[@amindavidalmontenunez7751]

Alguna literatura especifica para esta prueba?

[@timsandle9533]

Good stuff

[@arifarman3298]

Sir would you please answer me a question? My question is " in case of cephalosporine facility, if the highest commercial batch is 15000 nos in 12 hrs is it permissible fill 18000 nos in 6 hrs?