Installation and Calibration Services for GxP-Compliance and Accuracy

A calibration is a reliable, reproducible, and documented comparison of a device under test (data logger, sensor) with a traceable reference. The reference is a high-precision instrument, which is checked regularly by an accredited laboratory (accreditation bodies for Switzerland: SAS/SCS; USA: ANAB or NIST; Germany: DAkkS; UK: UKAS). A calibration is performed at one or several defined measurement points. To perform the calibration, a device/machine is needed to keep a stable environment:

For temperature:  A calibration bath, block or fixed point (i.e. ice water or liquid nitrogen) keeps a constant temperature to let the two devices adjust to the temperature point (e. g., for 30 minutes).

For humidity:  A humidity generator or a reference solution (salt water) generating a defined humidity at a given temperature to let the two devices adjust to the relative humidity (e.g., for 2 hours).

The two sets of measurements (the device under test and the reference device) are compared. A decision is made on conformance to specification and the result is documented in a calibration certificate.

Regulations around calibration and recalibration are primarily focused on ensuring that measurement instruments maintain accuracy and reliability over time, especially in industries where precision is crucial, such as pharmaceuticals, healthcare, and life sciences. Specific rules vary by industry and region, but key principles generally include:

• Calibration frequency: Regulations often require that equipment be calibrated at specified intervals, based on manufacturer recommendations, the critical nature of the device, and how often it is used. In industries like pharmaceuticals, the frequency of calibration is often tied to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), which stress that equipment must remain accurate to ensure product quality, safety, and compliance.
• Recalibration after maintenance or repair: If a device undergoes maintenance, repair, or any event that may affect its accuracy, recalibration is typically required to ensure that it still meets the necessary standards. This is important in maintaining GxP (Good x Practice) compliance.
• Traceability to national or international standards: Calibration must be traceable to recognized national or international standards, ensuring the device's measurements are aligned with universally accepted values. This is often a requirement under regulations such as ISO standards or the U.S. Food and Drug Administration (FDA) regulations.
• Documentation and records: Regulations generally require comprehensive documentation of calibration and recalibration activities. This includes keeping records of calibration results, certificates, and any corrective actions taken. These records are important for demonstrating compliance during audits and inspections.
• Qualified Personnel: Calibration and recalibration should be performed by qualified personnel who are trained in the proper methods and who follow industry standards. Regulations often stipulate that those performing calibrations must have the necessary knowledge, tools, and qualifications to ensure the accuracy and reliability of the calibration process.

In the pharmaceutical and healthcare sectors, these regulations are especially important because inaccurate measurements can affect product quality, patient safety, and regulatory compliance. Recalibration ensures that devices continue to meet necessary standards, providing confidence that measurements are reliable.

The frequency of recalibrating a sensor depends on several factors, including the type of sensor, its usage, the environment in which it operates, and the regulatory or industry requirements. Here are some general guidelines to consider:

• Manufacturer recommendations: Always refer to the manufacturer's instructions for calibration intervals. Many sensors have recommended calibration schedules based on usage and environmental factors.
• Regulatory requirements: In industries such as pharmaceuticals and healthcare, regulatory standards (e.g., GMP, GDP, ISO) often dictate calibration intervals. These guidelines can range from annually to more frequent recalibration, depending on the criticality of the measurements being taken.
• Sensor usage: If the sensor is used continuously or in harsh conditions (extreme temperatures, humidity, vibration, etc.), recalibration may be needed more frequently. In less demanding environments, the intervals might be longer.
• Environmental factors: Environmental conditions can impact sensor performance. For example, sensors exposed to extreme temperatures or corrosive substances may require recalibration more often.
• Performance monitoring: Some sensors may drift over time. If you notice any deviation in the sensor's readings or if the sensor is not providing accurate results, recalibration is necessary, regardless of the scheduled interval.
• Industry best practices: In certain industries, sensors are often recalibrated every 6 to 12 months, but more frequent recalibration may be required for critical applications.

In general, it's recommended to follow a preventative maintenance schedule, where sensors are checked regularly for accuracy, even if no issues are observed. If your application is critical (such as monitoring temperature in pharmaceuticals), more frequent recalibration may be necessary to ensure compliance with quality and regulatory standards.

GxP stands for "Good x Practice," where x represents different fields such as Manufacturing (GMP), Laboratory (GLP), and Distribution (GDP). It is a general term for regulations and guidelines ensuring quality, safety, and compliance in industries like pharmaceuticals, biotechnology, and healthcare.

Some common GxP standards include:

• GMP (Good Manufacturing Practice)—Ensures products are consistently produced and controlled according to quality standards.
• GLP (Good Laboratory Practice)—Ensures the reliability and integrity of laboratory studies.
• GDP (Good Distribution Practice)—Ensures proper handling, storage, and transport of pharmaceutical products.
• GAMP® 5 (Good Automated Manufacturing Practice)—Ensures that computerized systems in the pharmaceutical industry are validated for compliance, quality, and patient safety

These guidelines help maintain product quality, regulatory compliance, and patient safety.