About the Crimping Process

A stoppered vial is a prevalent parenteral drug container closure system. The system however should not be considered integral until the rubber stopper is crimped firmly in place with sufficient compression against the vial, assuring all potential leakage is cut off at the seal interface. It is well understood that seal quality is critically important to maintaining sterility and stability of the drug product.

Seal integrity is achieved by adequately compressing the elastomeric closure against the sealing surface of the vial and maintaining that compression with a crimped aluminum ferrule. The amount of elastomeric compression is determined by the force applied during the crimping process. Aptus allows for realtime setting and monitoring of the forces applied to the elastomeric closure during this process which in turn, reduces variability of stopper compression, producing more consistent seals.

The Aptus

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Design Highlights

The Aptus was designed to satisfy the mid to large production crimping process. The system offers state-of-the-art controls and capping parameter settings. It is FULLY modular allowing small to large scale options to be easily implemented for all customer requirements. All functions are completed while the vial is under complete control in the stars and turrets of the Aptus. The “system” functionally consists of two additional stars immediately following the standard capper discharge star, and a platform on which marking and reading equipment can be mounted on the capper. The first additional star is used to position the vial for marking and reading, the second serves as an eject star for non-conforming vials. The capper utilizes modern servo controls for critical motions including the rotary motion of all stages and the vertical motion of the capping head assembly. The overall height of the capper has been kept to a minimum allowing it to fit in tighter spaces. The cap hopper can be offset to the discharge side of the capping head to minimize particulate and further reduce the height of the unit. The Aptus has also been designed to help you meet the European Annex 1 regulations of the Manufacture of Sterile Medicinal Products.

Flexibility

Genesis recognizes that each customer may have different requirements for both upstream and down stream system integration. While we offer standard capper features and options, the design concept provides a flexible platform, with the vial under complete control, on which a wide variety of customer preferences can be accommodated.

Raised Stopper Detection

The Aptus platform is very flexible and can be fitted with a vision based raised/missing stopper detection system. As the vials enter the capper they pass in front of the system which determines whether or not a stopper is missing or raised based on the criteria that has been set in the PLC/PC based controls. All vials failing this criteria are rejected and ejected out of the system by a starwheel before entering the sealing stage of the capping process. The system is based on a Dual Camera system with Color Smart cameras. The redundant cameras offer extended coverage of the vial inspection. Color cameras allow for very detailed inspection of stoppers and ensure the proper components are being used.

Vial Marking and Verification

The Aptus can be equipped with a post capping marking system with an immediate OCR vision system confirming that the mark has been properly applied (is able to be read). In the event of a non-conforming mark, the vial will be ejected from the production line for further action. With the optional vision system located prior to the labeler, the system ensures full compliance with current regulations. Options are available for ink jet and laser marking. When the Applied Force Monitor option is elected, the system can identify the cause for rejection for each vial and maintain batch records (in addition to all the normal Applied Force Monitor functions).

Post Sealing Inspection

The Aptus can be fitted with a post sealing inspection station to visually inspect vials as they exit the sealing station on the capper. As the vials leave the capper sealing station they pass in front of the system which determines whether or not a vial has been mis-crimped or is missing a seal entirely based on the criteria that has been set in the PLC/PC based controls. All vials failing this criteria are rejected and ejected out of the system by a starwheel before continuing down the line away from the capping machine. The system utilizes two vision cameras to increase the coverage of the inspection. Color cameras are utilized to allow for inspection on cap and button colors to ensure the proper components are being used.

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	Specification
Max Speed (vpm)	120 - 300 Vials per Minute
Sealing Technology	Sealing Rail
Hopper System	Gravity Fed Vibratory
Seal Size	13 - 32 mm
Seal Style	All Standard Serum
Vial Diameter	12.7 - 82.55 mm
Vial Height	28.702 - 158.75 mm
Construction	316 Stainless Steel
Control System	PLC with PC Touchscreen Interface
Vial Infeed Sensor
Jam Control Sensor