Dr. Fábio A. S. Leite, subject matter expert for Pharma, Testo Saveris discusses how in the pharmaceutical sector, sensors are the frontline of medicine integrity, safeguarding sterility, maintaining quality and ultimately facilitating patient care.
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Errors in the accuracy of these can have consequences far beyond the purely financial, and this is reflected by the complex regulatory frameworks surrounding their usage and maintenance.
The risks associated with sensor error are far-reaching. Sensor drift can lead to loss of accuracy, in turn prompting poor control decisions and misguided actions on automation systems, potentially completely compromising a critical environment. It can also mean reduced data reliability, which in turn prevents long-term trend analysis, not to mention the obvious potential for non-compliance.
So, how can we mitigate the risk of sensor error?
As specialists in pharmaceutical measurement, calibration and validation, we’re often asked about sensor management in critical environments, and whilst the answer will always depend on the application and specific sensor, below are some of the most important considerations to bear in mind:
1. We don’t calibrate everything, but we do calibrate what matters
When developing a calibration program, the first priority is to ensure that resources are focused on calibrating and validating the right equipment. Not all sensors require calibration, and those that do may require different intervals between calibrations, meaning a detailed schedule is required.
The type and regularity of calibration in pharmaceutical measurement depends on a number of factors, including environment, manufacturer guidance, how critical the application is and sensor type. A risk assessment should be used to determine which instruments have GxP impact, and an approved standard operating procedure (SOP), defining its calibration method and required frequency, developed for every relevant sensor.
2. Calibration is only as good as the person (and tools) performing it
The process of calibration relies on a specific set of expertise. While the pharmaceutical industry is no stranger to resource challenges, only qualified technicians should be entrusted with calibration responsibilities. For long-term calibration quality assurance, regular competency assessments should be undertaken, with detailed training records associated to each technician.
Furthermore, separation of duties is vital to minimise the risk of errors. This means that a different qualified individual should be responsible for the execution phase, independent review and quality approval of the calibration.
In terms of calibration tools and equipment, these should be subject to their own checks. Each item should have unique identification, and clear labelling as to when it is next due to be calibrated. Interim checks should be scheduled for the tools between uses to check for damage or drift, and protective handling required at all times.
3. If it wasn’t documented, it didn’t happen
This is the number one rule when it comes to calibration – data integrity relies upon thorough documentation, and it’s the audit trail which ultimately secures a calibration program. Each step and element must be documented according to relevant principles, for example ALCOA+, to ensure the integrity of the program, and more broadly, the monitored environment.
Documentation should include calibration instrument IDs, associated firmware, the references used, raw readings, any corrections or uncertainty, signatures and timestamps. Validating the calibration is also vital, so the inclusion of as found/as left data is an essential part of the documentation process.
For pharmaceutical environments, there is no room for error. Environmental monitoring is a crucial part of delivering life-saving solutions, and that monitoring cannot be considered reliable without comprehensive calibration programs in place. Managing measurement, calibration and compliance can seem like a byzantine task, and even if basic requirements are met, an inefficient approach can mean valuable data is lost in endless rounds of paperwork.
Using an automated monitoring system, such as our testo Saveris 1, enables efficient documentation, data management, and GxP-compliant quality assurance with minimal external input, simplifying the complexity of environment management. Similarly, choosing a single source calibration service can not only save time and resources, but provide complete reassurance, with providers such as our Testo Industrial Services unit offering calibration, test equipment management, qualification and validation in one place.
Sensors are the guardians of critical environments, and to ensure they are able to preserve the conditions which facilitate life-saving medication, correct calibration in pharmaceutical measurement truly makes a difference.