Once product has been manufactured and packaged, there are requirements for how you handle, store and distribute the finished product. 21 CFR 820 breaks down the requirements for each of these processes. A manufacturing company should establish procedures that will deter mix-ups, damage, deterioration or contamination from happening during handling and storage of product. These…Details
Usually one of the last items you think of when designing a new product, the packaging actually provides a critical function. It is the barrier between the world and your medical device – meant to keep your product intact and functioning as designed. Medical device packaging must be tested for stability. This will provide assurance…Details
Manufacturers are required to have labels for product and product labeling. According to the FDA in section 201, a label is a “display of written, printed, or graphic matter upon the immediate container of any article” whereas “labeling includes equipment labels, control labels, package labels, directions for use, maintenance manuals, etc.” 21 CFR 820 specifically…Details
Both FDA’s 21 CFR 820 and ISO 9001 have requirements for document control. The goal with this section of the standards is to demonstrate that your quality system is compliant, that you design and manufacture products to meet design controls, and that your company is addressing risk management concerns. The FDA typically takes the approach…Details
3 Reasons to Use DataTrace Pro
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.
There is a requirement to perform As Found results before use in EO, 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.
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 compliant and has the ability to maintain regulatory compliance while processing and handling data.
Mesa has created a service network specifically suited to provide in-house services to our customers. Whether your needs call for equipment repair, calibration or process validation, Mesa’s Global Services team is uniquely qualified to provide you with specialized service, expert protocol development and execution and complete validation services to suit every need.
Location is everything!
If your sensors are in the wrong place, you can’t get accurate readings. We offer a wide range of accessories to ensure the proper placement of your loggers so you get the most reliable data. And, we can create custom accessories for even the most unique processes.
Inside Data Loggers
A data logger is an electronic device used to record data over time in a particular position or placement. Data loggers are designed to measure a wide variety of conditions and processes and selecting a proper data logger for a particular process can become somewhat challenging. As data loggers have evolved over time, their design has become much more specialized and their construction much more robust and customized. Programmable data loggers can be used to gain a lot of information about a process. The user dictates the intervals in which a reading is logged and, as is the case with DataTrace, can even dictate how and when the logger communicates it data to the server/software. Used in conjunction with its powerful reporting software, DataTrace Pro (DT Pro), DataTrace data loggers can be extremely useful for identifying cold spots, establishing sterility assurance or validating new equipment or processes.
In order to record the most accurate data, placement of data loggers is of the utmost importance. The closer a data logger can be positioned to the actual product/items being monitored, the more accurate the data is and the more information you have about the product itself as it is processed. Because of this, DataTrace MPIII and MPRF data loggers have been designed so that they can retrieve data from within a container or within the product itself.
Many data loggers are designed to measure temperature. Some measure ambient temperature, as in a room or warehouse, while others are intended to measure temperature in processes that are much more extreme such as a lyophilization process or inside an autoclave. Processes even reaching higher in temperatures (such as depyrogenation) are monitoring with data loggers, but not every data logger can monitor any process. DataTrace data loggers are engineered specifically for extreme environments such as steam, ethylene oxide and other various sterilization processes and chambers, heat tunnels, retorts, smokehouses, food processing and more. Autoclaves/steam sterilization, retort sterilization, dry heat ovens and tunnels, curing processes, food pasteurization and several other processes rely on accurate temperature measurements to ensure product/patient 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.
Humidity data loggers must be able to accurately record RH across the full humidity spectrum. Accuracy for humidity data logging is often of prime importance as humidity can alter or negatively impact product, it can be detrimental to equipment or materials, and can drastically alter the effectiveness of other processes. In Ethylene Oxide sterilization processes for instance, there are a number of factors to monitor. Certainly levels of EO are important as well as the temperature inside of the process or vessel. Central to the effective delivery of an ethylene oxide insult, humidity must be monitored closely to ensure that the sterilization process is successful. Typical EO sterilization processes require humidity levels to be near 50%, while humidity levels near 30% may be low enough to cause process failure.
Recording the pressure data from a canning, pouch or other food process is vital to ensure the safety of the items and the efficacy of the process. Pressure data loggers must be rugged to withstand the environment while also accurate enough to detect the smallest variances when monitoring food processing, supply lines, and other various industrial applications. A complete data logging system consists not only of high quality data loggers, but also incorporates software to collect, read, graph and report on the data after or, in the case of DataTrace RF, during the process itself. DT Pro gives the user the flexibility to fully customize reporting, data analysis and to program data loggers and logger groupings.