H.6.Investigation summary: one used sample without blister has been received for investigation.Upon visual inspection of this sample it can be observed leakage past the stopper in a 20ll syringe.The stopper is correctly assembled to the plunger.It is disassembled not observing any damage or molding defect in plunger rod that could have caused this defect.Dhr of lot 1504219 has been reviewed not finding any annotation or deviation regarding the alleged defect.In the assembly station tightness test is done to every syringe.In case any fails, it is rejected automatically to scrap.Ten retained samples of 20ll lot 1504219 are evaluated.Upon visual inspection of the ten retained samples, no damage or molding defect can be observed in any of them and the stopper is correctly assembled to the plunger in all of them.Leak test is performed with the 10 retained samples according to procedure pc-039 and iso 7886-1 annex d and no leakage happens in any of them.The syringes are disassembled not observing any damage or molding defect in the barrel or in the plunger rod that could have caused the alleged defect.Leak test is not performed with the used sample received since it is used and result could not be reliable (this syringe is single use).Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Visual inspection molding: 2 injections per shift.Printing: 18 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Assembly: 18 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Primary packaging: 1 advance-step (without product) per hour, after any intervention in the equipment, and once at the beginning of the shift.Secondary packaging: 1 shelf-package per pallet.Functional inspection printing: once in the first pallet, once in the middle of the lot and once in last pallet of the lot.Assembly: once in the first pallet, once in the middle of the lot and once in last pallet of the lot -primary packaging: once in the first pallet, once in the middle of the lot and once in last pallet of the lot.Investigation conclusion: this issue is not related to a manufacturing defect.Since no incidence happened during manufacturing process and retained samples meet iso7886 annex d, a definitive root cause cannot be determined.
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