Why a 17 Point Calibration?
 


Why a 17 Point Calibration?
Calibration is the process of bringing a device within tolerance of another device (usually a NIST-Traceable Reference Standard) that has been calibrated even tighter. When calibrating, we want to achieve an expected accuracy over a period of time, usually a year. We are comparing a device to a higher standard or better calibrated piece of equipment, creating repeatable accuracy. We want to bring a device more within tolerance, or more within accuracy as compared to higher standards. As we trace standards back up against even more tightly calibrated pieces of equipment, eventually the device being calibrated will reach the Gold Standard, or the standard that was mathematically calculated. The Gold Standard is a pure principle that cannot be changed or altered.
During the calibration, the manufacturer may need to adjust the unit to achieve the desired accuracy when comparing to the standard. The calibration is good once the device is found to be within tolerance. Please keep in mind that while you may know your device is not out of tolerance, after the calibration period the device is out of calibration.

The number of points required to achieve calibration depends on the device. There is no standard that says you are required to check a certain number of points. Some devices may require only 1 point, while others will require 18 in order to achieve the desired accuracy. The key is that the accuracy needs to be consistent among the entire range of points. To feel confident that our calibration is in tolerance across the entire temperature spectrum, we check our devices at 17 points.

Sometimes, we do change our calibration profile to include more data points during the check if it is required for the customer. However, we typically choose to do a 17 point calibration because that will cover the full temperature spectrum of our loggers with checks at a 10 degree interval. We can feel confident that our devices are within tolerance and maintain accuracy, and it gives the customer the assurance they need as well.

All of the checked calibration points are then listed on your Mesa calibration certificate. For more information on the anatomy of a calibration certificate, visit us at DataTrace.MesaLabs.com. 

FSMA Section 111 - Sanitary Transport of Human & Animal Food
We have been closely watching progress on the new Food Safety Modernization Act (FSMA) and sharing information throughout the past months to help keep our clients aware of changes that may affect their facilities and/or procedures. Now, we would like to turn our attention to a part of the FSMA, Section 111, Sanitary Transport of Human and Animal Food. Section 111 addresses the potential of food contamination during transport. This will directly affect shippers, carriers and receivers during transport through the following:
  • Sanitary Operations
    Food shipped in any container that is partially open to the environment can become contaminated. Cleaning and sanitation will be performed in manners that aim to avoid contamination of vehicles, equipment and food. Temperature monitoring during transport will be recorded and agreed to in writing.
  • Information Exchange
    Time and temperature requirements must be documented and demonstrated at the end of transport. The methods and procedures must be documented in writing and certain information must be shared between the shipper, carrier and receiver.
  • Driver Education and Training
    Documented training will provide drivers with knowledge of how to address food safety issues.
  • Records
    Temperature requirements for food safety must be maintained in records shared between shippers and carriers. There must be written procedure on how these requirements will be maintained and documented. All records must be made available to the FDA within 24 hours, upon request.
With Section 111, when temperature and/or time are essential for food safety, the shipper and/or carrier must apply and document appropriate procedures throughout the entire duration of transport. Records must be maintained, such as temperature requirements for food safety, when applicable. With the recent acquisition of Infitrak, Mesa is proud to offer solutions to meet these requirements:
  • Compliance Services
    -Temperature Mapping
    -Shipping Studies
    -Package Design and Testing
    -Transport Mapping, Qualification and Validation
    -Gap Analysis
    -Qualification and Validation
    -Hospital and Pharmaceutical Regulatory Compliance
  • Monitoring
    -Facility
    -Portable
    -Transport
  • TempTrust Qualified Packaging
    -Rugged Coolers
    -Packaging Services
    -Packaging Components
    -Calibrated Data Loggers
A detailed explanation of Section 111 is available here in an article authored by Cornelius Hugo.

For more information on how Mesa can help you prepare for the new FSMA Section 111, please contact an expert today.

Validation of Steam Sterilization Process
If terminal steam sterilization of medical devices, production or packaging components, final pharmaceutical product, or bulk active pharmaceutical ingredients is required, it is necessary that both the sterilization cycle(s) and the autoclave be validated. Validation of the autoclave and the sterilization cycle(s) is required by ANSI, AAMI, ISO, and the FDA to ensure that all items that are required to be sterile are able to consistently and reliably be sterilized to reduce the chance of introducing or spreading an infectious microorganism.

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