Validation Loggers - Applications
Sonoco packaging service provider helps in optimizing of data loggers
Sonoco is a supplier of consumer packaging, packaging for industrial products and packaging solutions and services. For this purpose, they use data loggers in various environments and areas of application, including high temperatures and high acid contents. However, the loggers were partially lost by the penetration of water. The following solution was found.
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Sonoco is a $5 billion global provider of consumer packaging, industrial products, protective solutions and display and packaging services. Headquartered in Hartsville, S.C., with more than 330 operations in 34 countries, they produce packaging for a variety of industries and many of the world’s most recognized brands, serving customers in 85 nations.
Sonoco’s operations consist of a global consumer packaging businesses –Rigid Paper and Closures, Flexibles and Plastics; their display and packaging division, which provides high-impact retail displays and packaging supply chain management; their industrial businesses, which manufacture tubes and cores, reels and spools, uncoated recycled paperboard and Sonoco Recycling, one of the world’s largest recyclers; and their Protective Solutions division, which produces custom-designed protective, temperature-assurance and retail security packaging solutions and highly engineered components.
The Challenge(s)
Sonoco uses Mesa Labs’ MPIII data loggers in various environments and applications, including high-temperature and high-acidity. On occasion, it has been noted that data loggers fail for water intrusion. This may sometimes be caused by the flattening of the o-ring.
The Solution(s)
Mesa Labs is committed to continual improvement of our products, as well as increased education to gain the best performance of our products for our customers. We suggest a parameter of 25% battery life be a marker for the battery to be replaced. When customers order new batteries from Mesa for their data loggers, a new o-ring and silicone are automatically included in the order. For each battery replacement, Mesa suggests replacing the o-ring, and applying a thin layer of silicone grease to increase the fluid barrier. We also intend on distributing our simple-to-follow battery replacement instructions with each battery and data logger order. This will provide better instructions for our clients on best practices.
More efficiency and cost savings with Validation Loggers
A manufacturing company for order development and production organization supports the medical technology industry with pharmaceutical, biopharmaceutical and medical devices. Our Validation Loggers provide flexibility and time savings. It is possible to restart a validation if the real-time temperatures deviate from the prescribed scale.
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Case Study: Confidential Client
A cGMP contract development and manufacturing organization, based in Irvine, California, supports the pharmaceutical, biopharmaceutical and medical device industries. The customer’s GMP services includes parenteral manufacturing (liquid/lyo), formulation development, analytical chemistry, analytical development, biopharmaceutical development, stability storage, structural chemistry, microbiology, and drug delivery device testing.
The Challenge
The customer has 66 chambers (refrigerators, freezers, incubators and ovens), which require semi-annual validation and qualification of the temperature. Using a competitive logger, they had to wait 24-48 hours to determine if the temperature had been out of specification. The process involved a pre-test of 4 hours, the 24-48 hour IOQ cycle, and then another 4 hour post-test with a competitive data logger. During this cycle, they were unable to tell if the loggers failed or remained within specifications until the full process had been cycled through.
The Solution
The Mesa Labs’ MPRF data loggers provided the customer with the flexibility to restart the validation if they see the real-time temperature go out of the specified range. Prior to using the Mesa Labs MPRF data logger, they were using a competitive product without real-time data capability. By using Mesa’s MPRF logger, they were able to decrease the cycle time by 12 hours on every chamber! Since 3 chambers are qualified each month, this saves the customer 432 hours of cycle time each year, estimating $8,600 in labor savings alone per year.
Testemonial
“The Mesa Labs MPRF data loggers have allow us to view real-time temperature data and stop and restart the qualification of the cycle if required. This has allowed us to become more efficient and reduce labor cost.”
- Installation, Calibration & Validation Services
Validation of Lyophilization Processes
The lyophilization process is essentially freeze-drying, where the environment is at a very cold temperature and the product is within a “vacuum”. During the process, there is a concern with making sure that the shelf is heating up the product to proper temperatures.
Pasteurisation of Beverage Cans
Measuring temperature/pressure processes over time inside beverage cans is a key element of bringing pasteurisation processes normally used on an industrial scale back to the laboratory.
Temperature Monitoring for Retort Sterilization
One of the most used methods for food sterilisation is retort sterilisation in an autoclave. With the help of our Autoclave loggers you can monitor temperature in real time, thereby optimizing your food production in many areas and providing traceable quality records.
Save Time in Thermal Mapping
Tired of with the hassle of thermocouple wires for your validation work?Having trouble correctly positioning the wires correctly inside the chamber, and inside packages of product? Fed up with all the pre-calibration and post-calibration issues associated with thermocouples? If you answered “yes” to any of these questions, then our wireless data loggers are the solution to your problems!
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Chamber thermal mapping and heat penetration studies are key to validating your equipment and processes, and are an important part of your GxP compliance program. The DataTrace system allows you to perform these critical studies in a fraction of the time required to do the same work with a wired, thermo-couple based data logger system. In the example below, of a 16-point autoclave thermal mapping, the DataTrace wireless loggers were found to save 65% of the time of a traditional thermocouple system.
Function Thermocouples DataTrace Pre-Calibration 30 mins - Sensor Placement 30 mins 5 mins Data Collection 45 mins 45 mins Sensor Removal 15 mins 2 mins Post Calibration 30 mins - Total 150 mins 52 mins Eliminate Pre and Post Run Calibration
Unlike thermocouples, the thermistor and RTD technology used in DataTrace data loggers long term calibration stability. This stability allows you to extend the time between calibration checks or eliminate them altogether.
Simplify Sensor Placement and Removal
DataTrace data loggers can be easily and quickly placed in chambers or rooms. Being wireless, there are no thermocouples or power cables to deal with - simply position the loggers in an apporpriate location and they are ready to collect data.
Improve the Accuracy of Heat Penetration Studies
The DataTrace data loggers are extremely small, robust, precision instruments that can easily be placed inside packages of products. Using appropriate fixtures, the tip of the temperature probe can be positioned exactly at the coldest point within the package, providing extremely accurate heat penetration information. The package of product can be sealed in its normal process, often without the need to make “ports” for thermocouple wires to extend into your packaging.
Real-time wireless validation eliminates thermocouples in Production Sterilization of Large Volume Parenterals (LVP)
Mesa Laboratories, Inc. has developed a true wireless solution that eliminates the need to use thermocouples in the validation of production autoclaves. How can one get an uninterrupted wireless signal out of a cascading water production autoclave during the sterilization of IV solution bags or retort with canned food?
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Real-time wireless validation eliminates thermocouples in Production Sterilization of Large Volume Parenterals (LVP).
Mesa Laboratories, Inc. has developed a true wireless solution that eliminates the need touse thermocouples in the validation of production autoclaves. How can one get an uninterrupted wireless signal out of a cascading water production autoclave during the sterilization of IV solution bags or retort with canned food? Mesa Labs has developed a prototype internal RF antenna that is easily mounted to the autoclaves existing sanitary fittings using a standard tri-clamp. This allows validation personnel to easily move the antenna from one autoclave to the next in minutes without the use of any special tools. Once the antenna is mounted, the data can be viewed using DataTrace Pro software from a laptop computer near the autoclave, your control room using our RF wireless repeater or anywhere you have access to your network using DataTrace Pro LAN.
Enhanced Reporting Options
Increased Graphical Control
DataTrace Pro software uses a SQL database that is accessible by other programs and it will replace chart recorders and thermocouple based recorders and systems. DataTrace MPRF loggers are a data logger first. Even if RF communication is lost, the data is not and DataTrace Pro will recover any data automatically.DataTrace Pro software was developed for validation technicians and engineers working in the food and drug industries. Some of the features include:
- Wireless automatic pre and post calibration verification with unlimited set points using your existing calibration equipment
- Fully configurable and customizable reporting
- User configurable statistical evaluation; user can assign Pass / Fail criteria
- Fully CFR Part 11 compliant – developed in a GmP environment for use in GxP applications
- Real time alarms with user definable operating options with e-mail messaging of alarm conditions
- Easy to configure LAN installations
Temperature Monitoring via RF in Smoke Houses
This application note details remote temperature monitoring via RF in smoke houses. This method provides relief to technicians working in hot and smoky conditions, while at the same time improving safety and quality levels.
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DataTrace Data Loggers in Smokehouses
Demonstration for Corporate QC and Plant QC for Meat Product Manufacturer, specifically showcasing MPRF and DTRF for use in 15 smokehouses. The smokehouses where the MPRF Temp units were located were at least 150 feet away from control room where DTRF was running inside a closed control room.
Evaluation:
Currently, QC sends a technician into the smokehouse directly after cook time is reached to get a physical temperature reading with a NIST traceable thermometer. The technician has to get at least six different readings within each and every smokehouse. The smoke- house is HOT, SMOKY, PACKED with product and DANGEROUS. The transmission of live data within the smokehouse will be a big relief for the technician charged with getting temperature readings. More importantly, it will help the facility com ply with HACCP, Safety and Quality initiatives. The MPRF were tested in the furthest smokehouses away from the control room, which were at least 150 feet from the control room. Then QC Manager placed the MPRF units in the back of the smokehouses (another 20 feet). Two repeaters were placed in line from the control room to the smokehouses. Placement of these was critical to get signal to DTRF running on computer within walls of control room. The laptop and reader station were placed with normal antenna configuration outside of control room door and transmission of live data was restored to 100%.
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Bio-hazardous Waste Heat Penetration Study
Equipment: 5 Data Loggers in each Autoclave - 4 Penetrations 1 Drain. Exposure Time: 30 minutes at 250˚F. Cycle Time: 2 hours The client chose DataTrace RF for this application because they wanted:
- The ability to monitor the autoclaves from a laptop in the Waste Disposal Area or a desk top PC connected to their network.
- Real-time actual N.I.S.T. traceable temperature reading at the coldest spot of each biohazard bag.
- The ability to release the load in real-time once all samples achieved required exposure temperature and time.
- To be confident they achieved sterilization.
- To reduce the current cycle from 120 minutes to 90 minutes which would increase the efficiency of the autoclaves by 25%.
- To be completely wireless and did not want to use thermocouples or semi-wireless systems which would dramatically increase the time to load and unload the autoclaves and would cancel any cycle time reduction.
- To reduce or eliminate the need to bring in costly third party validation companies each time they failed to achieve proper sterilization during bi-weekly biological monitoring tests.
- To eliminate the need for chart recorders.
Other Applications