for introduction of new operator to aseptic filling operation, he should undergo classroom training, gowning qualification and media fill. my question is that he does’t know the critical filling area operations like assembly of filling m/c parts, filtration setup, line operation and handling of intervention then how i can give direct handling of task to new operator? this is practically difficult because media fill operation also in risk. but based on media fill operations of new operator, operator will be eligible for routine filling operation. so is there any other system to handle such situation or any other method for evaluation of new operator?
Initially new operator works as helper with trained operator and learn all critical activity in filling area.thereafter new operator works as trained operator.there are many activity in filling area like assembling filling bunging sealing cleaning.task should be given as per skill of operator.when u think now new operator is perfect in critical activity then these activities can be handover to new trained operator.
Gowning qualification and knowledge of aseptic behaviour is must for new operator.
you should to done the operator validation for critical process parameter
thanks for reply manoj,
I agree to your statement as initial stage of operator to aseptic area assigning less critical jobs and further based on competency giving him critical job assignment but as per operator validation he must handle each activity individually during media fill before allowing him to work for commercial production as per our QA concern. to convince our QA i want to know if I will prepared protocol saying that based on initial gown qualification, system allow him to handle less critical job (unloading autoclave, area and m/c cleaning etc…) and on job training on critical operations of aseptic area for predefined period before final evaluation and certification, any supportive article or guideline reference or any rational doc. if anyone having data pl share me [email protected]
As per new practices u can implement the practical training to every new operator with sufficient time of two or three days after completion of SOP training and gowning qualification with practical trainer which is senior person can handle troubleshooting and he have to train person with his close supervision.