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The Importance of Data Logger Calibration
When managing temperature-sensitive products, particularly in laboratories and pharmaceutical environments, precision is critical. A GDP-compliant temperature data logger, complete with a valid calibration certificate, offers assurance that your equipment meets the necessary specifications for accurate monitoring.
A calibration certificate, especially when tied to ISO 17025 accreditation, verifies that the data logger, including its probes and sensors, meets high technical standards. This certificate certifies the competency of the laboratory or organization performing the calibration, proving that the results are trustworthy, accurate, and unlikely to be disputed. This is crucial for labs, fridges, and storage units that rely on precise temperature control.
GxP-Compliant Calibration
Suggestion: Calibrated sensors ensure precise, reliable measurements. Find answers to basic questions about GxP-compliant calibration.
The GDP-Compliant Cold Chain Data Logger
In pharmaceutical production, cold chain data loggers ensure that products remain within the specified temperature range from the point of manufacture to storage and through distribution. These data loggers continuously monitor and verify temperature conditions inside transport containers, fridges, or storage units, ensuring that medicines remain effective. A properly calibrated data logger is key to maintaining product safety, as even minor temperature excursions can render medicines ineffective or dangerous.
The transportation and distribution of pharmaceutical products can be a laborious and costly process if not done correctly. That is because medicines and a majority of medicinal products are susceptible to temperature changes.
They require close temperature control from the point of manufacture to storage. Even in transportation, uncontrolled environments can render the medicines useless and make some of them harmful for human consumption.
Statistics show that up to 30 percent of pharmaceuticals that get discarded or destroyed attribute the cause to unmanaged temperature excursions. In the case of vaccines, temperature excursions contribute to decreased efficiency for up to 35 percent.
Key Features for Data Loggers
- Accurate Temperature Monitoring: The probe used in a GDP-compliant data logger must be precise, ensuring the recorded temperature closely reflects the actual product temperature. Calibration helps verify that these readings are accurate.
- Specification Matching: Each data logger must adhere to the specifications required for the environment, whether it's a lab fridge or a large warehouse unit. Calibration ensures that the data logger's performance meets the standards set by regulatory bodies.
- Regular Verification: ELPRO recommends regular calibration of multi-use temperature loggers to avoid drift in readings over time. This is especially important for thermometers and other sensors that may degrade under continuous use.
Calibration of Cold Chain Data Loggers
Calibration in the measurement technology field refers to the process of comparing an instrument to a known standard. Calibration minimizes uncertainty by ensuring that the test equipment output is within the allowable accuracy range. After any calibration exercise, a certificate is mandatory.
All regulatory bodies require clients to work with calibrated sensors regardless of the document one chooses as a source for reference guidelines. Without a calibration certificate, there is no proof that the data logger produces the correct temperature readings. During audits, a calibration certificate is a mandatory requirement. Cloud storage provides safe storage from which retrieval is possible anywhere and anytime.
The calibration certificate is an official document that gives evidence of instrument calibration. Through the certificate, you can maintain device traceability. ELPRO provides a calibration certificate for data loggers because it validates any calibration claims and provides credibility.
Within the calibration document is crucial information about the logger's working condition, including out-of-tolerance details. Although the certificate contents will vary according to geographical location, important details include calibration dates, traceability statement, the calibration procedure, and interval. The document should also state clearly the standard used for the calibration process.
The calibration procedure for a cold chain data logger involves both temperature and, when applicable, humidity checks. For temperature calibration, a bath is necessary to allow the logger and the calibrator to come to the temperature point. During humidity calibration, a humidity generator provides a reference value. If the logger's temperature and humidity values do not correspond to the standard, an adjustment may be necessary or a replacement according to the perceived discrepancies.
Calibrating a data logger begins with inserting the device under test and the reference into the same environment. After some time, one can make comparisons of the readings from both devices. If the difference is more than the allowable tolerance, then readjustments must follow. The process continues until the deviation falls below the tolerance limit or there is no deviation at all. One should include all the calibration documentation adjustments to provide an accurate establishment of the adopted calibration procedure.
If there is a need for repair, the final documentation must show why, how, and what initiated the repair. It must also report on the success or failure of the endeavor. Hereafter, the issuance of a calibration certificate follows for the particular data logger.
Conclusion
A valid calibration certificate ensures your GDP-compliant data loggers are functioning within the correct specifications. By regularly verifying and calibrating your sensors, probes, and thermometers, you protect the safety of temperature-sensitive products throughout their lifecycle—from lab fridges to transportation units.
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