The Genesis RW NS Westcapper has been re-designed and improved to meet the current European Annex 1 regulations, “Manufacture of Sterile Medicinal Products”, with concern to capping parenteral vials. Below we outline the specific points of Annex 1 that the Westcapper addresses. If you have any further questions please contact us for a full presentation on the Westcapper and how it can help you meet current regulations.

 
Annex 1 119:
“As the equipment used to crimp vial caps can generate large quantities of non-viable particulates, the equipment should be located at a separate station equipped with adequate air extraction.”

The Westcapper:
One of the greatest sources of particulate generation in the sealing operation occurs in the hoppering of the aluminum seals. Genesis has moved the hopper of the Westcapper® to the discharge side of the machine separated from the capping station by a partition. The hopper is uniquely designed as a first in/first out unit where the aluminum seals are turned as soon as possible so that the cut edge of the aluminum seal is not able to abrade against other seals. The hopper also electronically monitors the flow of the aluminum seals so that it stops all rotation and vibration when additional flow is not needed. This also decreases particulate generation. One of the newest developments at Genesis is an air extraction system mounted behind the sealing rail. This system is designed to remove particulates created as the sealing rail folds the aluminum seal.

 
Annex 1 120:
“Vial capping can be undertaken as an aseptic process using sterilized caps or as a clean process outside the aseptic core. Where this latter approach is adopted, vials should be protected by grade A conditions up to the point of leaving the aseptic processing area, and thereafter stoppered vials should be protected with a grade A air supply until the cap has been crimped.”

The Westcapper:
When using non sterilized aluminum seals, grade A air may be supplied over the raised stopper and sealing platforms. When using pre-sterilized aluminum seals, grade A air may be supplied over the hopper as well as the first two stations.

Annex 1 121:
“Vials with missing or displaced stoppers should be rejected prior to capping. Where human intervention is required at the capping station, appropriate technology should be used to prevent direct contact with the vials and to minimize microbial contamination.”

The Westcapper:
Vials are inspected for the presence of a stopper as well as for raised or tilted stoppers prior to the sealing station. Defective vials are automatically rejected without the need for human intervention.

Annex 1 122:
“Restricted access barriers and isolators may be beneficial in assuring the required conditions and minimizing direct human interventions into the capping operation.”

The Westcapper:
Westcappers® are available with customizable safety enclosures which help isolate the sealing process. They are also available with air monitoring systems as well as viable and nonviable particulate counters that trigger alarm systems. Glove ports along with safety light curtains further reduce direct human intervention.
 
Annex 1 123:
“Containers sealed under vacuum should be tested for maintenance of that vacuum after an appropriate, pre-determined period.”

Laser heads to determine presence of vacuum can be mounted either on the inspection star before the crimping station or on a similar star wheel at the discharge side of the machine without substantially increasing the footprint of the machine.	Near IR sensors can be mounted under either the pre-crimping star wheel or the post crimping inspection star wheel to analyze product for moisture content.	The post-crimping star wheel can also be used to apply lot numbering or serializing identity to the vial as well as electronically tagging the vial if it has an RFID chip imbedded in the seal.