It's more clear than ever, especially amid the COVID-19 pandemic, that monitoring and documenting temperature, relative humidity, and other critical parameters are crucial not only during the production of pharmaceuticals but also in their storage, transport, and finally to the consumer through the pharmacy. The storage and distribution of temperature-sensitive vaccines have caught the public's attention through internet and television, making the public more aware of this as a key quality criterion. The importance of maintaining the cold chain was a common topic of public discussion.
We must not forget that this topic was defined many decades ago in the guidelines, specifications, and regulations of various organizations and regulatory agencies such as Good Manufacturing Practice or Good Distribution Practice. The WHO (World Health Organization), ISPE (International Society for Pharmaceutical Engineering), USP (US Pharmacopia), the FDA (US Food and Drug Administration), and European regulatory authorities have designed guidelines to ensure product quality over the entire lifecycle of a pharmaceutical product.
In this blog post, we would like to shed light on Kaye's role in this area of continuous monitoring.
From Handwritten Recording to GxP Compliant Monitoring System
The regular monitoring of temperature, relative humidity, light, CO2, or other critical measurements, for instance in the storage of pharmaceutical finished products, shows the full range of possible implementations. The spectrum ranges from reading and manually recording installed sensors, to cloud-based monitoring systems with uninterrupted data access whenever the data is needed. This reflects the technical development since the mid-1970s. Also, the initial, very rudimentary recommendations from regulatory authorities have evolved into very detailed guidelines and regulations that require corresponding technical solutions for implementation by the pharmaceutical industry. Nowadays, in addition to the physical implementation of corresponding sensors, data integrity requirements (audit trails, 21 CFR Part 11), a user-friendly software interface and flexibility in terms of data access and data evaluation are important stipulations.
How was this implemented in the Kaye product line?
The origins of using data loggers that recorded data on paper can be traced back to the 19th century. These were primarily used in meteorology and geological measurements, while in industry, they were mainly used to continuously monitor steam engines. These recording systems were based on mechanical components such as springs and levers to quantify and graphically display movements.
With the progression of industrialization in the 20th century, these devices were widely used in many industries and sectors, especially in manufacturing and production. The introduction of electronic versions in the 1970s and 1980s led to a revolution in data collection, enabling precise digital recording of measurements and replacing the classic physical mechanical movement with an electronic measuring method. This allowed for data-based processing and output of recorded measurements.
This was also true in the pharmaceutical industry, where multichannel data loggers were used to record measurements such as temperature, relative humidity, and pressure.
The precise recording of measurements such as temperature was, as we know from being loyal readers of this blog post series, exactly the topic of our company's founder. As early as the 1970s, the Kaye System 8000 was brought to the market for the technical implementation of industrial requirements. The ability to connect a multitude of temperature sensors along with other measurements such as pressure or relative humidity to the same base unit and create paper documentation developed into an industrial standard in many applications. Thus, Kaye data loggers were found in areas such as power generation in steam power plants, basic research, gas turbines, or simply monitoring refrigerators in the pharmaceutical or food sector. With more precise requirements in the GxP area, the development of a continuous monitoring system was a logical consequence.
The groundwork regarding the technical implementation was already laid. Successive models such as those from the Kaye Digistrip family reflected the technical progress. This was evident in improved accuracy, the growing need for more measurement channels, and the necessity to process measurement signals that were based on a 0-10V/4-20mA output signal in addition to temperature. With the introduction of the Kaye NetPac product line, almost unlimited possibilities emerged regarding the number of measurement channels and recorded measured values. The next step towards a continuous monitoring system, focused on data processing and evaluation. While a simple paper printout on thermal paper was sufficient in the early days, databases based on SCADA (Supervisory Control and Data Acquisition) were increasingly used. Future development steps shaped additional functions such as the definition of different alerting levels, the implementation of '21 CFR Part 11', data redundancy, the integration of graphical overview plans, and a growing desire for flexibility of the software interface.
In particular, the flexibility with respect to the number of measuring points and their easy placement, monitoring experienced a development surge with the introduction of wireless loggers. With the Kaye RF ValProbe in the early 2000s and the later development into the Kaye RF II Monitoring Loggers, this development was addressed.
Therefore, in this application area, both wired and wireless measuring systems are available for selection, which can be optimally used depending on the respective application.
The latest development has been a step away from onsite server-based SCADA systems towards a cloud-based data management system. In 2019 Kaye saw the introduction of the first GxP-compliant Cloud Based monitoring system, LabWatch IoT. This last step has allowed local and internal IT departments to free up precious time and resources, and allowing the client to actually use a system where data is the final result.
Conclusion
Over a period of 65 years, the technology for validating thermal processes in the pharmaceutical and biotechnology industry has continuously evolved. What once began with simple handwritten recordings has been continually developed through technological progress and growing requirements. Today, we have the ability to precisely capture complex measurement data and analyze and store it in a cloud-based data management system. Products such as those in the Kaye Digistrip family have significantly contributed to this technical development, offering enhanced accuracy and the ability to process a multitude of measurement signals. The GxP-compliant monitoring system, Kaye LabWatch IoT, introduced in 2019, represents the latest innovation. With its strong focus on technical innovation and adaptation to changing requirements, Kaye has secured a key position in continuous monitoring of critical parameters in the pharmaceutical and biotechnology industry. Moreover, through its core competency - the precise recording and processing of temperature, pressure and other measurements - Kaye has shown that continuous adaptation to technological progress is the foundation of its current success. This is true not only for the validation of a steam autoclave but also for the continuous monitoring of critical processes within the pharmaceutical and biotech industry.
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