When Gibraltar Laboratories set out to expand their contract sterilization capacity, they faced a common challenge: increasing throughput without adding multiple sterilizers or compromising product integrity. Their solution was the BMT USA Ventipro Steam-Air Mixture Sterilizer, a system that has since become central to their high-volume operations.
About Gibraltar Laboratories
Gibraltar Laboratories provides contract sterilization and testing services to pharmaceutical and life science manufacturers. Their operations require the flexibility to handle diverse container types, from small vials and bottles to large-volume flexible infusion bags, while maintaining strict process control and cGMP compliance.
The Challenge
To keep pace with growing demand, Gibraltar needed equipment that could deliver three things simultaneously: faster cycle times, consistent terminal sterilization performance across varied loads, and validated processes that meet cGMP and FDA requirements.
The technical requirements were specific. Any new system would need to safely sterilize sealed liquid containers without causing deformation from pressure differentials, maintain uniform temperature distribution across mixed loads, and speed up the heating and cooling phases of the process cycle to maximize daily throughput.
The Solution
Gibraltar selected the Ventipro specifically for fast terminal sterilization of pressure-sensitive loads. The system’s precise control over three critical parameters, temperature, pressure, and airflow, made the Ventipro an ideal solution for their needs. Unlike conventional steam sterilizers, the Ventipro uses a combination of steam, filtered air, and fan circulation to produce uniform conditions throughout the chamber.
Two features proved especially valuable for Gibraltar’s operation: overpressure control, which safely sterilizes sealed liquid containers without deformation, and the sterilizer’s internal convection fans, which accelerate heating and cooling, significantly reducing cycle times and ensuring the load leaves the chamber dry and ready for labeling.
The result is a sterilization system that handles Gibraltar’s diverse product mix while significantly shortening the total process time in support of their high-throughput production.
The Results
The Ventipro delivered measurable improvements across Gibraltar’s sterilization workflow:
Increased Daily Capacity: These improvements have allowed Gibraltar to increase daily capacity and shorten cycle times across multiple load types, allowing Gibraltar to accept additional client work without adding equipment or extending operating hours.
Lower Operating Costs: The Ventipro’s efficient, non-proprietary design helps reduce both utility use and maintenance costs. The steam-air mixture and forced-convection system heat and cool loads faster, using less steam, water, and electricity per cycle without compromising sterilization performance.
By moving away from proprietary systems that required sole-sourced parts, Gibraltar now benefits from readily available components, easier maintenance, and lower long-term service costs.
Simplified Validation: Full integration with BMT USA’s PLC control system provides a 21 CFR Part 11 compliant documentation of every cycle, ensuring Gibraltar maintains audit-ready records that satisfy FDA requirements.
Improved Operator Experience: Ergonomic loading systems and intuitive controls reduce the physical demands on operators while minimizing the risk of manual handling errors.
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 increasingly stringent regulatory and sustainability requirements.
Learn how BMT USA can help your facility achieve faster, more efficient sterilization at bmtusa.com/ventipro