Technologies
Advancing The Industry Standard in Capping for Parenteral Vials
Oil Free Operation
Genesis has developed sealing heads and conveyor support assemblies (pods) that no longer require the use of oil for lubrication. Bronze spindle bushings in the sealing head have been replaced with self lubricating, FDA compliant, polymer bushings and the conveyor support assemblies have been modified to retain grease used during fabrication. By employing polymer spindle bushings, we have eliminated the need for oil in the machinery directly above the product. The potential for oil dripping on vials is eliminated. Additionally, the main bearings in the sealing head are sealed as well.
Genesis strongly recommends annual preventative maintenance to check and replenish grease in the conveyor support assemblies as well as some of the vial rest table bearings.
For Existing Westcappers®
After the above items have been replaced, the Bijur lubricating system can be disabled and/or removed.
Partial rebuild kits incorporating these features are available.
- To eliminate oil above the product, all service can be performed on site with the purchase of a new sealing head casting with upgraded sealed bearings and new polymer bushings.
- Additionally, for a totally oil free capper, Genesis can completely upgrade the conveyor supports.
Missing | Raised Stopper Detection
The RW Westcapper® platform is very flexible and can be fitted with a either a vision or laser 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.
These systems are also available to integrate into your vial line by the use of our Vial Inspection Platform if you already have a capper in place or have a Westcapper® which is not able to be upgraded. Learn more about the VIP here.
Applied Force Monitor
The Applied Force Monitor (AFM) was developed to work in conjunction with our line of Westcappers®. The monitor can be applied to both spinning roller and sealing rail technology machines. On sealing rail machines it will monitor up to three locations during the sealing process, each location adjustable for force range high and low limits. This means that the quality level, or acceptance criteria, can be easily dialed in to match the appropriate requirements for a particular application and regulatory requirement. An important feature to reduce unnecessary waste in less stringent applications. It is operator friendly, intuitive in operation, self diagnostic and includes imbedded help functions to aid in set-up and troubleshooting. The will also verify that a non-compliant package was, in fact, rejected. More importantly it is validateable and CFR21 compliant.
The AFM will also reject product for missing stoppers or missing caps, since both of these will impact the applied force being monitored. In addition, if the AFM needs to be turned off for a specific run, the software is configured to allow the capper to continue rejecting product for missing stopper or missing cap by use of other sensors monitoring these parameters. The AFM can also be retrofitted to existing cappers to produce a combined reliable, real time production, inspection and dispositioning system which will improve manufacturing efficiencies, increase confidence in finished product, reduce liability concerns and make regulatory and quality system compliance an everyday occurrence.
Marking and Verification
The Genesis Vial-Trak system allows the application of an identifying mark to a vial and the immediate confirmation that the mark is 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.
System Overview
All functions are completed while the vial is under complete control in the stars and turrets of the Westcapper® . 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. Originally designed as an optional feature on a new RW Westcapper® , an existing RW Westcapper® can be reconfigured to become a Vial-Trak system.
Flexibility
Genesis recognizes that each customer may have different requirements for a marking and verification system. While we will offer a standard package ink jet and camera system, the design concept provides a flexible platform, with the vial under complete control, on which a wide variety of customer preferences can be accommodated.
- Marking media ink or laser.
- Mark locations on top or side of cap or on side or bottom of vial.
- Marking characteristics can be alphanumeric or 2-d matrix.
Convenience
The Genesis solution to the vial marking needs of the pharmaceutical industry fits compactly in a footprint only slightly larger than the standard RW capper (not including movable equipment cabinets). It is complete, as Vial-Trak provides not only the marking function but verification of proper marking and rejection of unmarked or mismarked vials. Additionally, verification of the proper ejection (“eject verify”) is a standard part of the system. 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 RW Westcapper 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. This all happens at speed up to 750 vials per minute.
These systems are also available to integrate into your vial line by the use of our Vial Inspection Platform if you already have a capper in place or have a Westcapper® which is not able to be upgraded. Learn more about the VIP here.