The Applied Force Monitor (AFM) was developed to work in conjunction with our line of Westcappers. The AFM 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. This is 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 validatable and CFR21 compliant. 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.

Oil Free OperationGenesis 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 vial rest table bearings are now sealed.

Annex 1 CompliantThe Westcapper is a fully automated, constant motion, rotary capper equipped with a six, twelve or eighteen spindle turntable, a circular hardened rail section, Total Control Touchscreen and Allen-Bradley PLC.

A number of design improvements have been made to the RW Westcapper. Of these the most significant is the placing of the vibratory cap bowl to the discharge side of the capper. This greatly reduces the chances of particulate contamination in vials as they are sealed. The overall height of the capper has also been reduced due to the head height adjustment no longer raising and lowering the hopper system as it has been moved off to the side. The Westcapper has also been updated to help you meet the European Annex 1 regulations of the Manufacture of Sterile Medicinal Products.

Maximum operation speed is 750 vpm, depending on cap size. Desired machine speed is entered onto the Total Controls Touchscreen. The capper will automatically ramp up to set speed when put in the RUN function. This enables standard operations procedures to be met consistently with each vial.

The entire capping area of the machine is “Barrier Friendly” and is enclosed with an OSHA compliant safety shield. The capper will immediately shut down when the shield is opened.

For more information including images and video please visit our website at www.gen-techno.com.

The Genesis RW Westcapper has been designed and improved to help you meet the current European Annex 1 regulations, “Manufacture of Sterile Medicinal Products”, with concern to capping parenteral vials.

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.

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.

Optionally, 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.

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.

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. Visual inspection can also be done within this star wheel for the identification and ejection of vial’s with capping defects.

The RW Westcapper

18 Spindles 12 Spindles 6 Spindles

Max Speed (vpm) 750 600 300

Sealing Technology Sealing Rail Sealing Rail Sealing Rail

Hopper System Gravity Fed Vibratory Gravity Fed Vibratory Gravity Fed Vibratory

Seal Size 13-32 mm 13-32 mm 13-32 mm

Seal Style All Standard Serum All Standard Serum All Standard Serum

Vial Diameter 12.7-38.1 mm 12.7-57.15 mm 12.7-82.55 mm

Vial Height 28.575-158.75 mm 28.575-158.75 mm 55.549-180.84 mm

Construction Stainless Steel Stainless Steel Stainless Steel

Control System PLC Touchscreen Interface PLC Touchscreen Interface PLC Touchscreen Interface

Vial Infeed Sensor Standard Standard Standard

Jam Control Sensor Standard Standard Standard

The RW Westcapper Product MatrixApplied Force Monitor

Genesis Packaging Technologies is a leader in the science and technology of pharmaceutical vial processing and handling, specifically sealing. Genesis offers global service and technical support to meet industry expectations and assure compliance to regulatory requirements regarding container closure integrity. Genesis also manufactures instruments to test vial Residual Seal Force. Genesis has also organized Genesis Technical Advisors, a consortium of pharmaceutical packaging experts, providing training and consulting services to the industry.

Genesis is the successor company to The West Company, Machinery Systems Division, which it purchased in 1996. The company has manufactured serum vial capping equipment since 1946. During this period, well over 1500 pieces of equipment have been installed worldwide in pharmaceutical, veterinary, diagnostic and biotech facilities. Genesis continues to service and maintain this equipment.

All manufacturing, design, engineering, sales, and service is located in our offices in Exton, Pennsylvania USA. Value-added services such as spare parts inventory, comprehensive documentation, a complete design and engineering department, technical support staff, and qualified service technicians enhance our ability to service our worldwide customer base. All equipment engineered and manufactured by Genesis can be fully tested at our facility.

Genesis Packaging Technologies 435 Creamery Way Exton PA 19341 USATEL: 800 552 9980 E-MAIL: info@gen-techno.com WEB: www.gen-techno.com RW Westcappers™

The Industry Standard in Capping for Parenteral VialsSeal IntegrityA 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. The Westcapper controls the force being applied to the elastomeric closure during this process which in turn, reduces variability of stopper compression, producing more consistent seals.

ServiceGenesis stands by our products and will have a service technician onsite within 24 hours of your call to diagnose and solve any issues or problems that may arise with the operation of your capper.

We also offer a number of annual service options as well as upgrades for your capper including partial rebuilds which replace parts subject to wear which are directly related to the sealing process – includes complete sealing head (with spindle assemblies), bull gear, bottle rest assemblies and sleeves and bottle rest table wear plate. Partial rebuilds are performed at the customers’ site and usually require less than three days to complete. Other rebuilds include the main drive shaft, the conveyor support assembly, the main drive clutch, and the head raising gear box rebuilds.

Upgrades include, cap handling controls, bottle infeed/jam control relay, missing cap counter, the PSC Gauge for setting upper and lower spindle spring pressures – includes force gauge, actuator assembly, and head height indicator – for older electro-mechanical Westcappers, and a safety enclosure interlock upgrade. For more information on servicing and upgrades please visit our website or get in contact with our service group.

Not Just CappersGenesis has 60 years of experience as the leader in the science and technology of sealing pharmaceutical vials. Our technical experts have worked for component manufacturer’s so they understand the relationship between the package components and the sealing method and optimize the process to insure seal integrity.

The proper setup of the mechanical variables related to sealing technology is necessary in achieving a high quality package seal and insuring seal integrity.

In order to benefit from the full range of capper capabilities, a sound understanding of the interrelationship between package components, machine change parts and setup procedures is required. Genesis’s training programs offer a detailed study of these significant process categories which, when applied, will insure consistent high quality oversealing, seal integrity, and machine performance.

As the regulatory agencies around the world keep raising the standards, why trust container closure integrity to just anyone?