I observed many fibers in dry powder filled vials after reconstitution with swfi.what may be root cause if vials,rubber stopper,powder are OK.equipment cleaning is OK,swfi used for reconstitution has no fiber.
if every thing is ok then only source of contamination may b machine or dusters used for cleaning may not be lint free n release fibers.
We use lint free duster.when filled vials comes from filling area to packing area through conveyor belt.IPQA person take the vial and reconstitute it to observe the particulate matter.
Any other possible cause?
what is the nature of fibers?synthetic or ?
Brown color fine fiber
filling machine friction problem like previous problem?
or fibers from brush of machine etc?
Source of contamination was syringe used for reconstitution.we found many fibers at rubber tip of plunger.syringe was kept in open crate after every use.IPQA person used this crate for keeping QC sample of finished product so it may be fiber of carton.
sterile packed syringe is not used every time by IPQA?
No he use same disposal syringe many times.
It can be reused , clean the syringe and keep it in closed poly bag after use.
ys its the right procedure