RT Journal Article
SR Electronic
T1 In-Process Verification of Closure Seal Integrity
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 14
OP 19
VO 37
IS 1
A1 Connor, John T.
YR 1983
UL http://journal.pda.org/content/37/1/14.abstract
AB A method and system is described that can accurately determine the total force required to crimp a cap onto a vial and instantaneously determine closure integrity. This system determines in-process verification of seal integrity by comparing a pre-determined force to the force actually applied to the cap during the crimping interval. The applied force is sensed as a voltage variation by a force transducer, digitalized, and compared to a pre-determined set of force measurements known to produce an acceptable seal. If a preselected number of applied force measurements fall outside a preset force tolerance band around the pre-determined nominal set of force measurements, the container is automatically rejected. Defects that are detected and rejected are missing caps, stoppers or liners, broken glass, defective glass finishes that may have cracked during capping, and vials requiring excessively high or low capping forces.