Op deze wijze wil ik u nogmaals bedanken. Ik werk al 17 jaar bij Novartis (Alcon Couvreur NV). Kwaliteit en correctheid zijn onze topprioriteiten. Onze successen zijn mee te danken aan de fantastische ondersteuning van CMI.
Klant
Datatrace® stainless steel High Precision data loggers are engineered specifically for thermal vaidation processes with extreme environments such as steam, ethylene oxide and other various sterilization processes and chambers, heat tunnels, retorts, smokehouses, food processing and more. Autoclaves/steam sterilizers , retort sterilization, dry heat ovens and tunnels, curing processes, food pasteurization and several other processes rely on accurate temperature measurements to ensure product/patiënt safety, product integrity and process reliability. Though critical to many applications, temperature data logging is not the only crucial parameter that DataTrace data loggers can be useful for.
MPIII Temperature Data Logger
The durable, proven DataTrace MPIII Temperature Data Logger is designed to provide accurate data over a wide range of applications with remarkable ease. Its small size allows you to position the logger very near or inside the items you are monitoring. With a wide range of probe types, lengths and temperature ranges, you can be certain that there is an MPIII option that is ideal for monitoring your process. The MPIII temperature datalogger has a standard application range of -20 °C to + 140°C. With the optional thermal packs the High temperature Datatrace loggers can be used up to +400 °C. For more information visit our overview page.
MPRF Temperature Data Logger
DataTrace® MPRF Temperature data loggers deliver the data from chilling, freezing and room temperature to pasteurization, EO sterilization and depyrogenation. MPRF Temperature data loggers provide accurate data over a wide range with remarkable ease; from as low as -80ºC to +400ºC. This makes it easy to monitor processes across a wide spectrum of temperatures in a variety of different industries and products.
Powerful Regulatory Compliant Software
Mesa’s DataTrace Pro (DT Pro) Software is the heart of the DataTrace® MPRF and MPIII process monitoring solutions. From the creation of process reports, analyzing and understanding data, and complying with your regulatory requirements, DT Pro gives you greater insight and productivity while ensuring 21 CFR part 11 Compliance.
Field op application:
Steam Sterilization EN 285 and ISO 17665
Pasteurization
Depyrogenation
EtO Sterilization
Lyophilization
H2O2 Sterilization
Incubator Mapping
Washer Disinfector
Stability Chamber
Warehouse mapping
CTU’s and TCU’s
Cleanrooms
Laboratories
Retorts
Ovens and Industrial Drying
Three reason to use Datatrace Pro
Powerful Reporting Capabilities
In the food processing industry, we need lethality data to know whether the product is safe to eat. Autoclave customers processing for sterilization will need reporting capabilities to display pass or fail criteria for their process. All of this information can now be graphed and displayed all on one report with just one extra click for a quick, easy-to-read review of the process for anyone to check the results. The robust reporting capabilities of the DT Pro software provide beautiful reports with graphs and calculations such as lethality, pre- and post-calibration verification displays of loggers before and after the process, and a placement view of the data loggers. This is an efficient solution for a reporting engine with no post-processing required. Time and energy spent post-processing data in excel or other calculation software can be put elsewhere while the DT Pro software does that work for you.
In Software Pre- and Post- Calibration Verification
There is a requirement to perform As Found results before use in EtO-sterilization, because once the gasses have affected the sensor, you need to prove that it was in calibration the next time it is used, right before use. Being able to do pre- and post-calibration on your own saves a lot of time and hassle.
The software offers a “set it and forget it” type of calibration with industry standard controls and the ability to assess to a certain specified tolerance. It can calibrate loggers directly in the software and communicate with industry standard or leading metrology equipment. This saves time and energy while giving you the control over the calibration to determine which data points are being checked and verified. Your loggers will be kept within tolerance while removing hassle from the equation. Please note, it is still recommended that you receive factory calibration once per year, but performing it in house simplifies the process.
21CFR Part 11 Compliance
When it comes to 21CFR Part 11 compliance, if you are not compliant, you cannot use the data loggers and software, so it is imperative to know what regulations you need to meet and whether your software is compliant. 21CFR Part 11 compliance is great for pharmaceutical communities with regulatory compliance needs under the FDA that need to show they are meeting requirements on a regular basis. DT Pro software is 21CFR Part 11 compliant and has the ability to maintain regulatory compliance while processing and handling data.
Wat zeggen onze klanten?
CMI is een betrouwbare en professionele partner voor wie kwaliteit en dienstbaarheid van zeer groot belang zijn, en waarmee we ongetwijfeld verder zullen samenwerken.
Klant
Het is steeds een plezier om te werken met het gemotiveerde team van CMI! Iedereen is ontzettend behulpzaam, enthousiast, en ze hebben een fantastisch verantwoordelijkheidsgevoel. Ze zijn steeds welkom!
Klant
Als CMO in de biofarmaceutische sector besteedt Novasep Belgium speciale aandacht aan de kwalificaties van haar productiezones, apparatuur en uitrusting. Sinds ongeveer 10 jaar is CMI een partner gebleken die wij absoluut kunnen vertrouwen en waarop we kunnen bouwen voor het realiseren van deze doelstellingen.
Klant
Ontdek onze industrieën
