Today’s integrity testers use the latest control and instrumentation techniques to automate the testing process. It helps pharma personnel accurately determine the integrity of packaging without human involvement and prevents errors. It also increases the tester’s ability to perform integrity testing with less time and resources. It also provides functionalities and resources that best suit the regulatory body requirements and enhance process and product improvement.

Instrumentation has become common in almost every pharmaceutical equipment, machine, and measuring device. Instrumentation in integrity testers has also become common, and the industry nowadays has moved from traditional, manually operated techniques to sophisticated and automated procedures.

Function of instrumentation

Let’s discuss some instrumentation functions in an integrity tester and how it automates the entire testing procedure.

Less Human Involvement

The most common function of instrumentation in packaging integrity testing is to limit human involvement in the entire process. Humans only define the set of parameters, and instrumentation helps to follow these set operating procedure paths. This also allows humans to concentrate more on planning rather than spending their time, resources, and energy executing the process.

Less human involvement also increases process reliability, which in turn has a positive impact on the pharma product. It shows the organization’s commitment to safe products, reliable systems, and its adherence to regulatory and market requirements.

Automated Records

Instrumentation systems help produce an automated record of every test performed without error. It also enables to record of the results at a regular frequency without losing any set of information and data point. This helps reduce errors associated with manual recordings, such as inaccurate readings and erratic time intervals. The automated data recording can also be adjusted to a minimal time interval, such as in the range of seconds. 

The records can also be stored digitally without human involvement in the instrument’s internal storage. This is now the common feature that every integrity test manufacturer is offering. With these systems, records can be stored for a longer duration, for months or even years. These records can be polled directly into the database, such as in the personal computer, for data analysis and report generation.

Ease of operation

Instrumentation helps to use the packaging integrity tester conveniently and quickly. Instrumentation performs the primary function of data collection and process monitoring, which relieves humans of these tasks. Instead, they can focus more on decision-making and improving products and processes.  

Ease of operation also increases the process and product reliability. Conventional integrity testers, which depend on manual operation, are hard to operate and prone to human and instrumental errors. The operators struggle with several difficulties, including instrument readiness, sample preparation, process monitoring, and analyzing and compiling results. All these factors significantly reduce the ease of operating the integrity tester.

Enhanced Security

Instrumentation provides enhanced security features such as data security and protection against unauthorized access. Safety in today’s pharmaceutical is paramount because it saves an organization from illegal activities and data breaches.

Data has become more critical for every pharma manufacturer because of different analytics techniques. These analytics process the data and output a predictive model on which the entire working of the instrument depends. If the data collected is not secured, it will affect the instrument’s performance.

Similarly, this data becomes part of the batch documentation or batch history, which is reviewed by the regulatory bodies during their inspection. 

Access to various user levels

Instrumentation enables different user levels in an integrity tester. It divides the operating status or permission within the integrity tester between personnel depending on their roles and designation.

For example, a person with a higher role in a production department or laboratory can change an operating parameter such as time and pressure. Similarly, a person having a lower position, such as an operator, can only be given access to operate the integrity tester without changing operating parameters.

Types of Instruments

A typical integrity tester can have instruments depending on functionality and user requirements. However, a common integrity tester includes the following instruments.

Differential Pressure Sensor

Differential pressure sensors are used to measure the difference in pressure between the sample packaging and the test chamber (in which the sample package is put to the test). The sensor can measure pressure value when pressure is applied. It can also measure the vacuum in the container if the test requires vacuuming. The selection of a particular type of differential pressure sensor depends on the integrity tester and the product being tested on the tester.

When pressure is applied to the chamber (containing the sample packaging), it then exerts pressure on the packaging. If there is a leak or hole in the packaging, the chamber pressure value decreases. The differential pressure sensor then measures the difference in this pressure. 

The main controller and internal circuitry converts the pressure difference to an equivalent value, in an human readable format. Depending upon the set parameters and acceptable values, main controller marks the sample pass or fail.

Automation Components

Automation components are used to automate the working of the entire packaging integrity tester and commonly include the following.

Human Machine Interface – HMI

Human-machine interface – HMI provides a user interface to humans with packaging integrity testing. It is an electronic device with a touchable screen that can respond to human touch. HMI then converts these touches into alternate commands, depending on the screen area. It can program any feature, function, and command by designing the screen graphics according to the user and process requirements. The HMI directly communicates with the main or programmable logic controller – PLC to give the command and exchange any information.

HMI in packaging integrity tester is used to control the entire testing process. Some common functions that HMI performs include the following.

Process Start: HMI is used to start the testing procedure. 

Parameters Adjustment: HMI is used to adjust process parameters such as applied pressure and time.

Result display: HMI is also used to view and display the result of integrity testing with detailed parameters. For example, if the consequence passes, it can display it with operating parameters. If the result is a fail, it can display at which value the test failed.

Process monitoring: it displays the status of the on-going testing process, such as the current stage of the test and remaining time, etc.

The main controller (or programmable logic controller)

The main controller is the heart of the automation system and is used to operate the packaging integrity tester. It monitors various instruments and sensors, such as differential pressure sensors, and controls the tester’s functionalities, such as pressuring or depressurizing the container. 

The main controller can control both analog and digital input instruments. For digital inputs, the controller outputs high or low logic to either ON or OFF the system. For analog inputs, the controller outputs analog values, i.e., 4 – 20mA or 0 – 10V, depending upon the instrument type. 4mA or 0V being the lowest values, while 20mA or 10V being the highest value. 

The main controller is connected to the human-machine interface to take commands from operators such as process start, stop, or parameter setting. It then controls the entire integrity tester depending upon the set parameters through the human-machine interface. 

If the main controller becomes damaged, the packaging integrity tester will become useless until it is rectified. 

Audit Trail

An audit trail is an ability of a software to trace any changes in system data. It provides a detailed, human-readable report of changes occurred in the entire operating parameters. The report is non-erasable and un-editable and cannot be deleted or altered as long as the system is in working condition.

An audit trail is the latest technique for ensuring transparency in testing the integrity of the packaging. This feature is also becoming an essential requirement for most regulatory bodies worldwide, such as FDA in the United States. It keeps a record of changes in every data set of the integrity tester and prepares the report. The report is updated every time a change occurs and cannot be edited or deleted in any circumstances or by any means. This report also cannot be edited by the owner of pharmaceutical organization.

For an audit trail, following information can be included

·        Personnel detail: it includes full details of person such as User ID, name and designation who has made the changes

·        Time and date at which the personnel has made the changes

·        Details of parameter changed

·        Value of parameter changed, from initial value to the final set value.

User with password protection

Users with password protection are providing a barrier in accessing different user levels with a password. Personnel can only access a particular user level with a dedicated password. The desired user level will not be provided if it fails to give the correct password.

User level and their password can only be accessed via administrative rights.

User with password protection helps to restrict specific users from operating certain functions and features for product and process safety. In this system, personnel with the highest designation or responsibility are given a higher user level, while those with low responsibilities or designation are given a lower user level.

Read More:

Optimizing the Packaging Process through Packaging Integrity Testing | Pharmasources.com

About the Author

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.