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Media simulation trials for aseptically filled products 

Tim Sandle
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22 окт 2024

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Комментарии : 7   
@pharmigmicrobiology2456
@pharmigmicrobiology2456 3 года назад
Very useful introductory video
@majdiayoub2500
@majdiayoub2500 2 года назад
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
@timsandlemicrobiologist 2 года назад
Hello, you need to switch to using an identical transparent bottle for the simulation.
@majdiayoub2500
@majdiayoub2500 2 года назад
@@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
@amindavidalmontenunez7751 3 года назад
Alguna literatura especifica para esta prueba?
@timsandle9533
@timsandle9533 3 года назад
Good stuff
@arifarman3298
@arifarman3298 3 года назад
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?
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