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.
View a 3D Model of the Aptus
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.
FlexibilityGenesis 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 DetectionThe 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 VerificationThe 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 InspectionThe 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.
Features & Options
Data Storage/Reports (21CFR11 capable).
User/Active Directory & Network Integration.
Improve Your Crimping Process with Our Technology Partners
|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|
Berkshire Sterile Manufacturing & the Aptus
The Genesis Aptus Featured in New Filling Line
In 2020 Berkshire announced plans for a new fully automated, highly flexible and 100% isolator-based filing line. That line is now constructed and undergoing validation. The video linked to below offers a first look at the completed line. See how the Genesis Aptus modular vial crimping system plays a key role in helping Berkshire deliver the highest degree of sterility assurance possible on this new line. Berkshire Sterile Manufacturing provides small scale sterile manufacturing services with the highest level of sterility assurance and quality achievable through the use of the most modern technologies for sterile manufacturing, stringent quality standards and highly trained employees.
Change Parts Cabinets
Heavy Duty Rolling Cabinets to Organize & Store All Your Change Parts
Heavy duty powder coated steel cabinets on industrial castors making them easy to move, so you can position them exactly where you need them. Each drawer is custom configured to organize and store all your specific capper's change parts. Available in two sizes.