As an aseptic manufacturing facility, we are looking at the best practice for frequency of personnel monitoring in the Grade A/B area. Given my expereince I have seen companies who perform personnel monitoring (garb & gloves) after every entry when performing critical tasks, others who perfrom this on a daily basis for each operator and then sometimes only weekly.
I believe that weekly is insufficient but we do not have the resources to perform monitoring for each entry.
Has anyone any suggestions about how best to identify the ideal frequency for personnel monitoring.
Hi!
In our sterile zone, we monitore the gloves of the personnel when perform any critical task and in every gloves changing.
The gowning is monitored only in class A when they leave the zone, in order to prevent the possible contamination.
Weekly is not a good frequency; its insufficient to assure that the product will be ina minimal risk of contamination. that is the purpose of this kind of controls.
hI… IMEX… actually the best practice is every one follow the rule and i think the best rule is how to prevent contamination… and the objective of monitoring process is to assure that every one follow the rules… so IMO… we have to check the people follow the rule by visual every day and to verification of that you can use swab test weekly…