Mesa Laboratories - Wireless and Real-Time Data Loggers and Software for Pharmaceutical Process Monitoring and Validation

Mesa Laboratories offers high-quality data loggers for monitoring temperature, humidity, and pressure, and biological indicators (BIs) for medical device and pharmaceutical manufacturing sterilization monitoring. The DataTrace data loggers and Mesa BIs are available to monitor and validate applications including steam and EO sterilization, autoclave validation, incubators, heat tunnels and more.

Mesa also offers an extensive array of testing services related both to its line of data logging systems and to its expertise in the biological indicator manufacturing field. Validation services make up a large part of Mesa's focus moving forward and continue to be a growing component in our offering to companies globally.

Wireless real-time data loggers

Mesa designs and manufactures DataTrace, a high performance, wireless, data logging system which offers the ability to monitor temperature, humidity or pressure without using an out-of date wired system. Mesa's newest products, DataTrace MPRF temperature, humidity and pressure data loggers, deliver the convenience of real-time process data with a wireless data logging system. The use of DataTrace MPRF data loggers can save up to 2.5hr (65%) of valuable time that is required to set up a wired system.

Mesa's DataTrace Pro Software is the heart of the DataTrace MPRF and MPIII process monitoring solution. From the creation of process reports, analyzing and understanding data, and complying with your regulatory requirements, DataTrace Pro gives you greater insight and productivity.

DT Pro integrates smart security and regulatory capabilities including an audit trail log for all security levels, data encryption, electronic signatures, enhanced password protection and administrative security options. Installation validation is now easier than ever with new system configuration reports. IQ/OQ/PQ documents and a validation manual are also available. These features allow you to achieve FDA 21 CFR Part 11 or GxP compliancy.

Biological indicators and sterility assurance products

Mesa is the industry standard for biological indicators (BIs) offering innovative products such as ProSpore Ampoule and EZ-Test (SCBI's), Apex specialty carriers and BIs, spore strips, suspensions and ProChem chemical indicators and integrators. This proven line of indicators allows users the ability to completely monitor their processes and maintain an extremely high sterility assurance level. Whether using steam, H2O2, EO or any industrial process, Mesa offers an indicator for any load configuration or situation.

Combining the product lines from its Raven, SGM and Apex divisions, Mesa presents the most complete line of biological indicators to serve the pharmaceutical and medical device industries while bringing decades of expertise and services to its customers.

Contract testing services

Mesa's biological indicator manufacturing facilities offers steam, dry heat, and ethylene oxide (EO) D-value testing following USP recommended procedures. Mesa can inoculate product and perform D-value analysis using AAMI compliant BIER vessels and can verify another manufacturer's claim for population and D-value/z-value using Spearman Karber (fraction negative) or Survivor Curve methods.

Offering custom inoculation for sterilization cycle validation studies, Mesa can work with your solutions or with representative stoppers and/or septa to perform bioburdern, D-value and z-value testing. Mesa also offers specialty biological indicator and process challenge device (PCD) development, D-value testing of inoculated pharmaceuticals and medical devices in steam, vapor H2O2 (hydrogen peroxide), EO and dry heat. Autoclave cycle validation, heat penetration studies (thermocouple or data logger) and third-party confirmation of BI label claims are also available.