K
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.
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.