Data recording has a significant place and requirement for the pharma industry. It represents the current state, and tracks different processes for efficacy, safety & quality. It is also the regulatory requirement to record all the relevant data, which is also reviewed during routine inspection.

The critical requirement for data collection is accuracy. The data must depict an actual picture of the process. The error in the data collection mostly comes through humans, who directly measure and record the data. 

One way to tackle human error is by using automated techniques that automate the data monitoring, recording, and collection. For critical industries, such as pharma, these data collection techniques require additional considerations, such as maintenance and regular calibration. 

A Data Logger is an instrument to measure, monitor, and record data automatically. They can be integrated with any pharma process without limiting or degrading the performance of the pharma process. 

What is a Data Logger?

A Data Logger is an electronic device that measures different process variables over time. This contrasts with other measurement devices, which only measure and display the current value. A data logger can also store values in its memory. 

They take input from different sensors, such as temperature & pressure. The values can then be recorded in an appropriate output form.

Some data loggers can indicate the measured values on a digital display, while others can print them on paper in a graphical form. Communicating the measured values to other electronic controllers for further processing or centralized data storage is also possible. Some models also allow storing values in removable storage media for data transfer. 

Importance of data loggers for the pharma industry

Let's discuss the importance of a data logger for the pharma industry.

Effective Monitoring Technique

A data logger can accurately monitor process  values of the product & environment during different stages of manufacturing, storage, and transportation. It helps to detect problems with the equipment or machine, and ensure the product remains safe. 

Helps detect problems within the cold chain

A data logger helps detect temperature anomalies during the transportation of temperature-sensitive products. The data logger can be programmed to alert relevant staff to initiate relevant corrective and preventive actions.

Parameters recording for compliance requirement

While maintaining temperature, environmental, and other parameters in the acceptable range is a regulatory requirement, it is also necessary to record these parameters, which must be documented. Regulatory bodies review these records during their visit.

With a data logger, it is possible to log and record parameters properly and present them to regulatory bodies.

Applications of  data loggers in the pharma industry

The pharma industry has a wide range of applications for data loggers, some of which are listed below.

Cold Chain Monitoring

Cold Chain is integral to the pharma supply chain and primarily transports temperature-sensitive products. It is necessary for cold chain systems to monitor the temperature of the cold chain during the entire product duration.

Data loggers provide real-time feedback about the temperature, humidity, and other required parameters of the cold chain. They provide critical data to monitor the entire phase of the cold chain that can be used to solve problems, if any, and improve the cold chain performance. 

Additionally, data from data loggers can also be used to review & improve product characteristics, packaging specifications, warehouse conditions and transportation methods.

Cleanroom Monitoring

A cleanroom is a specially designed enclosed area that maintains controlled environmental parameters, according to the pharma industry standards. They can control contamination, foreign particles, and microbes to provide sterile conditions for processing products. 

The environmental parameters require continuous monitoring, which data loggers commonly perform. It is used to record temperature & humidity. They can also be designed to monitor other parameters, such as room pressure, which is selected as per the quality or regulatory guidelines.

After the process is completed or time has elapsed, log values throughout the entire period can be recorded by transferring to a storage medium, or as a paper graph. It can also be connected to Computer, PLC or HMI through RS-485 or Ethernet ports.

Warehousing

Like other industries, warehouses are an integral part of the pharma industry. They are used to store raw material, packaging material, finished products, and other items used in pharma manufacturing processing.

 The warehouse is provided with all the relevant facilities for safely storing the materials, and one of which is environment control. Parameters, such as temperature and humidity, are maintained per the material's requirements.

Data loggers are used in pharma warehouses to monitor the environmental parameters. They help maintain adequate environmental levels, ensuring the quality & safety of the stored product. 

Additionally, products are stored in the warehouse for multiple days for industry-specific reasons, and temperature and other variables must be maintained for an extended period. The data logger's storage capability also helps monitor & store values for days. Pharma manufacturing

Pharma product manufacturing is the processing of different chemical compounds under favourable conditions, which helps to create the required therapeutic effects. The final product will lack the desired properties if these conditions are unmet. 

One of these requirements is the temperature to provide desired heat value for the chemical reaction between the chemical compounds.

In these pharma processes, it is necessary to keep a temperature record during the entire process for product safety and regulatory requirements, and a data logger is used for this purpose. Like other pharma processes discussed above, it records the temperature value during the entire period. 

Some manufacturing processes where data logger can be used include 

· product mixing in a vessel

· Coating

· Granulation.

Sterilization

Sterilization is a common process in the pharma industry, where the product or items used in manufacturing are sterilized to remove harmful particles and microorganisms. The process  includes heating items to a high temperature for a specific period. This high temperature for a particular time kills the microorganism and other harmful particles.

During the sterilization process, it is necessary to record temperature values with fixed frequency, for compliance requirements, and product safety. A Data Logger records temperature values after regular intervals throughout the sterilization  process.

Commonly, the record is maintained in paper form, which is then made part of the batch record. 

Validation

Validation is a critical activity in the pharma industry, where the quality department ensures the integrity of each pharma process. It is written evidence that a process will constantly produce results according to its specification. Among other processes, quality personnel validate temperature-related equipment, instruments & processes.

Data Loggers are used to perform validation of temperature-related data. The data logger used is fully maintained through regular maintenance and calibration. The output of a data logger is used by the quality department to pass or fail the instrument being validated. 

What should you look into as a data logger for your pharma application?

Different types of data loggers are available in the market. It is necessary to look for the features that suit your  pharma applications.

The following are some features specific to the pharma industry.

What is your measured parameter?

There are different types of variables that can be processed by a data logger. When selecting a data logger, consider what variables you want to measure. Another consideration is the range of the variable and time period. 

The data logger must be able to process the required parameters within the necessary range. For accuracy, the data logger must be compatible with the relevant measuring sensor.

Record transfer & Access

As mentioned earlier in this article, there are multiple methods to display & transfer collected data, such as manual paper-based, electronic, or interfacing with other automation components.

If your pharma application requires a standalone data logger, you can opt for a manual paper record or transfer through a storage medium. On the other hand, if your application requires interfacing with a centralized controller, such as a PLC or HMI, the data logger must be provided with a relevant port ( S 485 or Ethernet) that enables transferring these values to these controllers.

Recording & storage duration

Different data logger variants have different recording and storage capabilities. Some can record data for hours, while others are designed for days.  Similarly, some data loggers can store less data, while others can store larger amounts.

The selection of the parameters mentioned above depends on the process requirement. If you use the data logger for the manufacturing process, less recording & storage can be sufficient, because the process does not take longer to complete. On the other hand, if you plan to use a data logger for logistics or warehousing, it requires more recording & processing capabilities, because usually it takes days to reach the pharma product or material to its destination. 

Power requirement

Data loggers can be powered by electricity from a standard AC supply, while others use battery systems. 

If a data logger is used in a pharma manufacturing facility, and the application allows easy power access, an AC-powered data logger can be used. On the other hand, if application usage restricts electric power access, such as in the cold chain, a battery-powered data logger is suitable.

Regulatory requirement

Data Logger for pharma application must follow relevant regulatory requirements, in which it plans to market or sell its products.

The data logger should include 21 CFR part 11 features - electronic records & signatures for the reliability of the electronic records generated by the data logger. Additionally, it must be calibrated at a regular frequency for its optimum and error-free function.