Hi folks,
We have a client that feels they need to do some validation work with the labels they use. They purchase label stock with some pre-printed information and then print additional information (lot number, etc.) immediately prior to application on a plastic vial (read "medical product"). The vials contain an alcohol solution so we have verified the labels maintain integrity when exposed to (actually soaked in) the solution for over an hour.
They have had some instances of labels peeling off unexpectedly - potentially due to exposure to cold (that's not been confirmed). In any case, these vials will be transported over land / air so they will be exposed to a wide range of temperature, humidity, and pressure.
We're struggling with the bounds of the validation effort. UL 969 appears a good candidate for guidelines. Can anyone suggest alternatives, maybe more suitable to medical? Can anyone suggest additional validation tests? Thanks.
We have a client that feels they need to do some validation work with the labels they use. They purchase label stock with some pre-printed information and then print additional information (lot number, etc.) immediately prior to application on a plastic vial (read "medical product"). The vials contain an alcohol solution so we have verified the labels maintain integrity when exposed to (actually soaked in) the solution for over an hour.
They have had some instances of labels peeling off unexpectedly - potentially due to exposure to cold (that's not been confirmed). In any case, these vials will be transported over land / air so they will be exposed to a wide range of temperature, humidity, and pressure.
We're struggling with the bounds of the validation effort. UL 969 appears a good candidate for guidelines. Can anyone suggest alternatives, maybe more suitable to medical? Can anyone suggest additional validation tests? Thanks.
