Wednesday 18 October 2023

Role of the future: Monitoraggio microbiologico ed Annex 1


Monitoraggio microbiologico ed Annex 1. Intervista a Tim Sandle


In the new Annex 1, microbiological contamination from materials entering the cleanroom is provided with a far greater emphasis. This has been identified as one of the major routes of contamination for items coming into the facility. The optimal means of transfer is via a double-ended autoclave and using moist heat. Where this is not possible, of where single-use sterile items are required, then a disinfection process is required. This can be automated (as with a decontamination chamber using a vapour like hydrogen peroxide or chlorine dioxide) or a manual process using a transfer hatch equipped with a localised HEPA filter air supply.


AM Instruments incontra Tim Sandle sui principali temi del nuovo Annex 1: processi di sterilizzazione, monitoraggio microbiologico, trasferimento dei materiali, isotecnia e contenimento, cleaning e disifezione e, per concludere, la disinfezione delle mani.


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Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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