The Challenge
When Gibraltar Laboratories set out to expand their contract sterilization services, they faced the common challenge of increasing throughput without having to make the substantial capital investment of purchasing multiple additional sterilizers. Their operations required the flexibility to handle diverse container types, ranging from small vials and bottles to large-volume flexible infusion bags.
To keep pace with growing demand, Gibraltar needed a single system capable of delivering faster cycle times and consistent terminal sterilization across these varied loads. This required a process that accelerates the heating and cooling phases without sacrificing temperature uniformity. Furthermore, the sterilizer had to safely process sealed liquid containers without causing deformation due to pressure differentials.
Finally, the system needed to meet specific industry regulations, including current Good Manufacturing Practices (cGMP) and 21 CFR Part 11 for electronic record-keeping and audit readiness.
The Solution
Rapid Terminal Sterilization without Compromise: Gibraltar chose the Ventipro for its ability to provide rapid terminal sterilization of pressure-sensitive loads. To do this effectively, the process must tightly control temperature, pressure, and airflow throughout the chamber.
Unlike traditional units, the Ventipro is equipped with internal fans that circulate a mixture of steam and filtered air around the product containers, creating uniform conditions across the entire load and improving heat transfer. This allows for faster heating and cooling than a static system, reducing cycle times and ensuring the load exits the chamber dry and ready for labeling.
Protecting Packaging Integrity with Air Over-Pressure: To prevent damaging the product container, the system must generate an air over-pressure to counteract the internal pressure that naturally builds as the liquid load heats and expands. The Ventipro accomplishes this by introducing compressed air into the chamber, maintaining a precise external pressure that balances against the internal pressure of the containers. This equilibrium prevents the packaging from bursting or deforming, ensuring the physical integrity of the product is maintained throughout the sterilization cycle.
Reducing Maintenance Costs with Non-Proprietary Components: The Ventipro utilizes a fully non-proprietary design, eliminating expensive sole-sourced components, ensuring parts are readily available and reducing long-term maintenance costs. The system also features ergonomic loading carts and an intuitive controls interface to minimize operator strain. Furthermore, the controls software is fully compliant with 21 CFR Part 11, providing Gibraltar with secure, traceable electronic records required for regulatory audits.
The Result
The Ventipro delivered measurable improvements across Gibraltar’s sterilization workflow. The sterilizer’s ability to shorten cycle times across multiple load types allowed Gibraltar to increase their daily throughput and increase capacity without needing to add multiple sterilizers or extend operating hours.
The steam-air mixture process enables faster heating and cooling, reducing Gibraltar’s utility consumption without compromising sterilization performance. This improved efficiency helps lower overall operating costs while maintaining high quality standards. Additionally, 21 CFR Part 11 compliance ensures Gibraltar maintains audit-ready records that satisfy FDA requirements.
The Bottom Line
For contract sterilization providers like Gibraltar Laboratories, the Ventipro steam-air mixture sterilizer provides a competitive advantage. By delivering faster cycles, lower operating costs, and consistent performance, the Ventipro helps CDMOs scale their operations while meeting stringent regulatory requirements
Learn how BMT USA can help your facility achieve faster, more efficient sterilization at bmtusa.com/ventipro