Real-time, non-destructive container closure integrity measurement

A method for determining container closure integrity in a container system comprising a container, an elastomeric stopper, and a retainer for retaining the stopper in place, wherein the elastomeric stopper is confined between a rim of the container and the retainer to seal the container, and wherein the method comprises:

• measuring, with a detection system, a resistance of a force sensitive resistor disposed between the elastomeric stopper and the rim of the container or the retainer;
• determining container closure integrity based on the measured resistance value.

A method of configuring, validating, or monitoring a filling line for producing filled container systems, the method comprising:

• filling and sealing one or more container systems, the sealed container system comprising a filled container, an elastomeric stopper comprising an embedded positioning component, and a retainer for retaining the stopper in place, wherein the elastomeric stopper is confined between a rim of the container and the retainer to seal the container, wherein the method comprises:
• determining, using a detection system, a position of the embedded positioning component;
• based on the measured position of the embedded detectable component, determining container closure integrity.

A method of configuring, validating, or monitoring a filling line for producing filled container systems, the method comprising:

• filling and sealing one or more container systems, the sealed container system comprising a filled container, an elastomeric stopper, and a retainer for retaining the stopper in place, wherein the elastomeric stopper is confined between a rim of the container and the retainer to seal the container, and wherein the method comprises:
• measuring, with a detection system, a resistance of a force sensitive resistor disposed between the elastomeric stopper and the retainer;
• determining container closure integrity based on the measured resistance value.

A detection system for determining container closure integrity for a container system comprising a container, an elastomeric stopper comprising an embedded positioning element, and a retainer for retaining the stopper in place between the retainer and a rim of the container, the detection system comprising:

• a sensor configured to determine a position of the embedded positioning element within the container system;
• a controller configured to determine container closure integrity based on the measured position of the embedded positioning element.

A container system comprising a sterile seal, the container system comprising:

• a container,
• an elastomeric stopper, and a retainer for retaining the stopper in place, wherein the elastomeric stopper is confined between a rim of the container and the retainer to seal the container
• a force sensitive resistor disposed between the elastomeric stopper and the rim of the container or the retainer.