MadgeTech Blog — Life Sciences

3 Factors to Consider when Sterilizing Dental Instruments

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Just like any other branch in the health care industry, dentistry is held to strict guidelines set forth by the Centers for Disease Control and Prevention (CDC) and the American Dental Association (ADA). Ensuring the highest level of patient and personnel safety relies on the implementation of an infection control program.

At the center of an infection control program, outlined by the CDC, is the proper sterilization and disinfection of patient-care items and devices. This step is critical to ensure all instruments are free of hazardous bodily fluids and materials. A staple at any dental facility, an autoclave, is utilized to validate sterilization cycles are carried out according to government regulations.

As one might expect, this is a process that must be executed with enormous care, as even a slight procedural lapse can compromise patient health. This includes the regular monitoring of the autoclave to ensure it is operating as expected. According to the CDC and ADA, dental professionals should carefully check three types of indicators when validating the effectiveness of the sterilization process.

Chemical

The use of indicator tapes and other types of chemical indicators can help the technician determine whether the autoclave has reached proper sterilization temperatures. An indicator tape works by changing color if sterilization conditions reach a certain threshold. If the indicator does not respond, it should be assumed that any item being sterilized during that cycle is not sterile. The use of this indicator alone is not a guarantee that sterilization was effective.

Mechanical

It’s important to monitor temperature, pressure, and cycle duration while validating or using an autoclave. To accomplish this, technicians typically use high-quality data loggers. In fact, there are data loggers that are specifically designed for use with autoclaves and provide reporting tools for easy data analysis and confirmation.

Biological

Finally, biological monitoring is important to root out problems with the autoclave and ensure successful sterilization cycles. According to the CDC, an autoclave used in a dental setting should be examined for biological indicators at least once a week. The technician may elect to use spore monitoring strips or resort to a “mail-in” service to check for the presence of harmful microbes.


It’s worth pointing out that, in addition to the above, a dental practice may be subject to state and local regulations that might impose further regulatory obligations. Dental professionals have a responsibility to stay current with any applicable guidelines.

Data Logger Requirements for Pharmaceutical Temperature Mapping

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PharmaMapping-Full

The pharmaceutical industry is one of the most regulated industries in the world, so it’s no surprise that temperature mapping is imperative for temperature-controlled storage areas. Temperature mapping identifies hot and cold zones so necessary actions can be taken to equally distribute air, which in turn, will ensure the products’ integrity.

FDA

Under 21 CFR 205.50, the FDA states that all prescriptions drugs must be at the appropriate temperatures and under appropriate conditions in accordance with requirements. The regulation goes on to state that electronic temperature and humidity recording devices can be used to document proper storage of prescription drugs. But that is as far as the FDA goes when it comes to how to proper conduct a temperature mapping study.

WHO

The World Health Organization (WHO) provides greater detail into how temperature mapping studies are carried out for those who store and transport time and temperature sensitive pharmaceutical products.

 “All new temperature-controlled storage areas must be temperature-mapped as part of a fully documented verification process, before the installation is commissioned and handed over by the installer.”

Electronic Data Logging Monitors

WHO recommends the use of data loggers along with its corresponding software to store and analyze the data collected during the study. When choosing a data logger for study, the logger must meet the following:

  • Be technically suitable for the specific mapping task and for the intended operating environment.
  • Provide a reliable and continuous reliable record of time-temperature data.
  • Have an appropriate temperature range so that all anticipated temperature extremes can be recorded (e.g. from -30°C to +60°C).
  • Have a user-programmable data sampling period, with time intervals ranging from one minute to 15 minutes or more and sufficient memory for the intended length of the study and the chosen recording interval.
  • Have a NIST- traceable 3-point calibration certificate with a guaranteed error of no more than ± 0.5°C at each calibration point.
  • Allow the recorded time-temperature data to be downloaded to a computer system for subsequent analysis.
  • Have data storage and analytical software that complies with applicable regulatory requirements (21 CFR part 11).

Maintenance

Mapping studies should be conducting over 24 to 72 hours, if not longer. The results will determine hot and cold spots where temperature sensitive products should not be stored, and actions should be taken to either fix those spots or install data loggers in that area for continuous monitoring. Temperature mapping is not just a one-time thing, it’s an exercise that must be carried out every three years in order to demonstrate continuing compliance, or whenever significant modifications are made to the store.

Summary

MadgeTech data loggers exceed the requirements outlined by WHO. With an ISO 17025 accreditation, MadgeTech offers a variety of temperature data loggers, which are held to the highest standards in the world. The MadgeTech 4 Secure Software aids users in compliance of 21 CFR Part 11 requirements, containing criteria such as electronic signatures, access codes, secure data file and an audit trail.

To help find the right data logging system for your temperature mapping study email us at [email protected] or give us a call at (603) 456-2011.