The Industry Standard in Parenteral Vial Sealing

Genesis Packaging Technologies stands at the forefront of parenteral vial sealing, offering advanced solutions that ensure container closure integrity (CCI) for critical injectable pharmaceuticals. With over 75 years of expertise, Genesis has developed the RW Westcapper®—a high-speed, fully automated rotary crimper designed to meet the rigorous demands of modern pharmaceutical manufacturing.

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.

Ensuring Container Closure Integrity in Parenteral Packaging

In parenteral drug delivery, the integrity of the container closure system is paramount. A stoppered vial achieves true integrity only when the elastomeric stopper is compressed adequately against the vial’s sealing surface and secured with a crimped aluminum ferrule. This compression ensures a hermetic seal, preventing microbial ingress and maintaining the sterility and stability of the drug product.

The RW Westcapper® addresses this critical aspect by precisely controlling the force applied during the crimping process. By regulating the compression of the elastomeric closure, the system minimizes variability, resulting in consistent and reliable seals across production batches.

RW Westcapper®: Advanced Design for High-Volume Production

• Optimized Cap Feeding: The vibratory cap bowl is strategically positioned on the discharge side, significantly reducing the risk of particulate contamination during sealing.
• Compact Footprint: Relocating the hopper system away from the head height adjustment mechanism has lowered the machine’s overall height, facilitating integration into various production settings.
• Flexible Configuration: The system accommodates vial flow from left to right as standard, with right-to-left flow available as an option. Conveyor heights range from 35¼″ to 38″, and the standard conveyor length is 98″, with customizable lengths upon request.
• Safety Compliance: An OSHA-compliant safety shield encloses the capping area, with interlocks that halt operation immediately upon shield opening, ensuring operator safety.

Commitment to Seal Integrity and Compliance

The RW Westcapper® is also available with advanced AI-based vision systems that enhance quality assurance throughout the sealing process. These systems can identify missing or raised stoppers prior to sealing, ensuring only properly stoppered vials are processed. Additionally, a post-crimping inspection module detects improperly sealed vials and cosmetic defects, helping to safeguard product integrity and reduce downstream defects.

Genesis Packaging Technologies not only provides state-of-the-art equipment but also offers comprehensive services to ensure optimal performance and compliance:

• Stopper Compression Analysis: Determines the optimal compression percentage to achieve leak rate cut-off, correlating values to Residual Seal Force (RSF) and verifying with standard leak testing methods.
• Machine Training Programs: Offers detailed studies on the interrelationship between package components, machine change parts, and setup procedures to ensure consistent high-quality oversealing and machine performance.
• Service & Training Packages: Provides annual service visits, preferred scheduling, and technical support to maintain equipment at peak performance.

Through these offerings, Genesis ensures that clients not only have access to cutting-edge sealing technology but also the knowledge and support to maintain the highest standards in parenteral packaging.