Hello,
I have question about taking samples for microbiological testing if critical product is antibiotic or antimycotic. Is it better to take those samples after production of this product (antibiotic/antimycotic) and cleaning equipment, or after next product which in not from this group of products?
Jovana
Senior expert associate
Hemofarm Vrsac, member of STADA group
[quote=Jovana]Hello,
I have question about taking samples for microbiological testing if critical product is antibiotic or antimycotic. Is it better to take those samples after production of this product (antibiotic/antimycotic) and cleaning equipment, or after next product which in not from this group of products?
Jovana
Senior expert associate
Hemofarm Vrsac, member of STADA group[/quote]
Assuming that “critical product” stems from the standpoint of product residue removal, it sounds like the identified critical product is not the worst-case for microbiological testing. You would get very little value using this approach from a micro standpoint. I think you are on the right track by suggesting a sampling plan after a “NON-antibiotic/antimycotic” product. Assuming you use the same cleaning method for both products, this would demonstrate that your cleaning process is effective at reducing the bioburden load to acceptable levels. I’m also assuming that you will challenge the process by holding the equipment in a dirty state for several days before cleaning.