Microbiological State of a Reagent Kit - Enquiry Regarding ISO 18113

K

kuertensun

#1
Dear all,

I am encountering a problem with ISO 18113-1: 2009, which says the manufacturer should state the microbiological state of a reagent kit. In my company, in the manufacturing process, the reagent vials are disinfected by radiation, the matrix are disinfected by filtration and the manufacturing environment is controlled to a certain level of microbes. However, all of these do not meet the requirements for sterile. In this situation, could I say the kit is microbiologically controlled?

thanks in advance for any help.
 
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Stijloor

Staff member
Super Moderator
#2
Dear all,

I am encountering a problem with ISO 18113-1: 2009, which says the manufacturer should state the microbiological state of a reagent kit. In my company, in the manufacturing process, the reagent vials are disinfected by radiation, the matrix are disinfected by filtration and the manufacturing environment is controlled to a certain level of microbes. However, all of these do not meet the requirements for sterile. In this situation, could I say the kit is microbiologically controlled?

thanks in advance for any help.
Can someone with this expertise provide help?

Thank you very much!

Stijloor.
 
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