Calibration Certificates for GDP - Compliant Data Loggers
What are the benefits of using a GDP compliant temperature data logger? When it comes to the ISO 17025 accreditation, it is a must-have for laboratories and research centers that perform tests and calibrate products.
This particular calibration certificate indicates compliance with technical and management requirements, and it's a way for a laboratory to claim their technical expertise and competency to the highest standards.
Also, having this accreditation from the International Organization for Standardization, a revered regulatory body, is a means to certify that the results are accurate, consistent with industry standards and protocols, and unlikely to be disputed in court, business setting, or by a customer.
Suggestion: Calibrated sensors ensure precise, reliable measurements. Find answers to basic questions about GxP-compliant calibration.
The GDP-Compliant Cold Chain Data Logger
A cold chain data logger is a crucial element in pharmaceutical production, storage, and distribution. It provides continuous monitoring to ensure goods remain within the allowable temperature conditions. A more important element is the data logger certification that assures its performance quality for the intended work.
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.
These challenges brought about the need for refrigerated freight containers, also called reefers. Additionally, temperature control in the storage warehouses became more of a necessity than an option.
A cold chain data logger provides temperature monitoring for pharmaceuticals in storage and in transit. Data loggers allow for data traceability and provide graphing options essential in pointing out any temperature excursions during transit.
Although not a worldwide requirement, GDP compliance is mandatory for EU pharmaceutical companies. It also covers any attached logistic partners where the company does not transport its products.
ELPRO is an avid advocate for GDP compliance and seeks to underscore the importance of adherence to storage and distribution temperature monitoring regulations. For consumer safety and product security, one needs a calibration certificate to show compliance with GDP regulations and stipulations.
GDP regulations are in place to help assure all involved parties that pharmaceutical products reach the destination in the required quality. They stipulate storage and transportation measures to combat temperature-induced product destruction.
In the long run, GDP compliance protects the consumer from counterfeit, substandard, and adulterated products. Producers and distributors enjoy minimized losses from faulty products and recalls.
The GDP scope covers the use of a cold chain data logger in a warehouse facility, in-transit, and through distribution channels.
In-store data loggers ensure the entire facility maintains a specified temperature range. In contrast, on-transit loggers ensure that the freight containers' inside temperature remains constant despite the prevailing outside conditions.
A calibration certificate for any cold chain data logger ensures compliance with safety requirements. The certificate denotes calibrations done to the satisfaction of set values and approves the data logger for use.
From the stated GDP, a few crucial features for any cold chain data logger are as follows:
It must include a temperature sensor that is measuring product temperature as realistic/close as possible. Before use, one must calibrate the sensor to confirm that its output gives the correct impression of the product temperature.
A GDP-compliant cold chain data logger must include continuous temperature monitoring to depict temperature fluctuations accurately: The thermal reaction time of the sensor should be the same or shorter than the thermal reaction time of the sensor.
ELPRO recommends a 15-minute interval between readings and memory storage for a minimum of 4,000 readings. That translates to 15-minute readings for 39 days. The integrated liquid crystal display should highlight the last temperature reading and include an alarm status indicator.
Calibration of Cold Chain Data Loggers
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, and thus, its accessibility should be easy. Cloud storage provides safe storage from which retrieval is possible anywhere and anytime.
A calibration certificate is evidence of a successful calibration process. Calibration in the measurement technology field refers to the process of comparing an instrument to a known standard.
Calibration is comparing the device under test to another device’s accuracy that meets the regulating body's set standards.
Calibration minimizes uncertainty by ensuring that the test equipment output is within the allowable accuracy range. After any calibration exercise, a certificate is mandatory.
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.
One will find crucial information about the logger's working condition within the document, 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.
A humidity generator provides a reference value during humidity calibration. 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.
The Occurrences of Drift
Temperature sensors are among the most stable instruments and can provide consistently accurate output over the years. Nonetheless, every instrument goes through wear and tear, especially data loggers that undergo continuous use.
The occurrence of atrophy inhibits perfect performance and introduces deviations from the standard. ELPRO recommends annual calibration of multi-use temperature monitoring devices.
That is especially crucial in the world of pharmaceuticals and vaccine transportation and storage. Since humidity sensors are the most unstable, they are prone to fluctuations more rapidly and require frequent calibration.
Deviations can result from the effect of the environment on the sensor. For an environment that requires accurate monitoring, calibration should be more frequent.
Other circumstances where calibration must be frequent are in cases of extreme environments. These can be very dry rooms to which the sensor is exposed. In such cases, due to the severity of the surroundings and their effect upon the sensor, a more frequent calibration practice will be more effective.
Ensuring the presence of a valid calibration certificate is paramount when working with GDP-compliant cold chain data loggers. More than instilling confidence in the monitoring system's accuracy, it ensures product safety in storage and transportation. Additionally, there is the certainty of user protection from damaged medicines and manufacturer protection from losses.