Validation timelines are often rigid, leaving little room for equipment failure. A common bottleneck in this process occurs when a single thermocouple fails during a qualification run. While the hardware failure itself is minor, in a standard setup, fixing the issue often causes major delays to the project schedule.
The Challenge with Traditional Lead Wire Bundling
In many sterilizer validation setups, multiple thermocouples are routed through a single compression seal. If one of the bundled probes fails, removing it can often disturb the seal and positioning of the surrounding wires, compromising the integrity of the entire setup.
To resume validation, the chamber must be re-mapped and leak-tested, followed by a full cycle restart. This results in wasted utilities and man-hours for what should be a routine maintenance task.
Isolating the Common Failure Point
BMT USA addresses these bottlenecks with the Multiple Thermocouple Validation Flange. The validation flange is designed to eliminate the risks associated with bundled feedthroughs by sealing each thermocouple lead individually.
By individually sealing each lead wire, operators are able to replace a single failed probe without affecting the vacuum integrity of the chamber or the positioning of the remaining wires. Because the surrounding probes remain undisturbed, there is no need to re-map the chamber or perform a new leak test on the entire bundle. The failed wire can be replaced in minutes, allowing the validation cycle to resume immediately without compromising the integrity of your data.
Integration into Standard GMP Validation Workflows
The validation flange is engineered to serve as a direct replacement for existing feedthroughs and fits standard 1½″ or 2″ tri-clamp validation ports. To match most standard chamber mapping layouts, the validation flange is available in 16 and 24-probe configurations, with custom configurations available upon request for specialized load requirements.
Accurate and efficient sterilizer qualification relies on minimizing process variables. By allowing for independent probe replacement, the Multiple Thermocouple Validation Flange removes a common point of failure, helping validation teams adhere to tight schedules, while ensuring their data remains consistent and traceable.
For more information or to discuss your specific application, please contact BMT USA to speak with a sales engineer.