Environmental monitoring in the pharmaceutical industry is a critical requirement of good manufacturing practices – GMP. It is used to make sure that Pharma product manufacturing is carried out in controlled environmental parameters. It also ensures that surrounding environment does not cause any harm or damage to the Pharma product during its entire production life cycle.
Environment monitoring includes detecting deviations in environmental parameters from standard values. This is achieved by analyzing the historical record of a particular area.
Keeping and analyzing historical data also enables for performance assessment, root cause analysis and implementing Corrective Action and Preventive Action - CAPA.
Importance of environmental monitoring
Let's discuss the importance of environmental monitoring in pharma industry, and see why Pharma manufacturers worldwide invest in this field.
Environmental monitoring is a critical requirement by regulated bodies worldwide for manufacturing Pharma products. Almost every regulatory body, critically reviews and asses the environmental monitoring practices and provide feedback if an improvement is required.
Regulatory bodies also inspect to see whether equipment and instruments for environmental monitoring are according to the highest standards of Pharma manufacturing requirement and regulatory guidelines.
If a regulatory body is satisfied with the environmental monitoring practices, equipment, and policies, it accreditations its manufacturing status. Otherwise, regulatory bodies can issue a warning or even shut down plant operations.
Helps in product safety
When implemented, properly, with appropriate equipment, practices, and guidelines, environmental monitoring helps product safety in Pharma manufacturing. This becomes necessary for aseptic product processing, where the product’s impact is higher than any other form.
Environmental monitoring also helps to detect, if a product is contaminated. In this case, the product can be immediately held back from release to save human life and, subsequently, protect the pharma organization from legal actions.
Indicate the status of processing equipment.
Environmental monitoring gives first hand status of the equipment responsible for maintaining the environment. Because there are several equipment and components involved in maintaining the environment, such as air handling units, filter systems, diffusers, and grills.
Although, during system design, special care is taken to prevent the accumulation of foreign bodies and tp prevent a possible source of contamination, chances are that during production, these components can cause problems for many reasons.
Environmental monitoring helps to determine what equipment has become a problematic or started to degrade. It also helps to solve these problems in advance, prevent breakdown in production operations.
Types of environmental monitoring
In the pharmaceutical industry, every physical entity that remains near a pharma product or manufacturing process is checked for monitoring. Let's look at common objects frequently monitored as a part of environmental monitoring program.
Air is a common medium for Cross contamination in a pharma manufacturing operation. If air quality is compromised, it becomes difficult to protect existing products or manufacturing processes.
Air Monitoring includes sampling and analyzing the air quality for microbial contamination. Some areas of a pharma operation where it is used are manufacturing areas, change rooms, and cleanrooms.
Commonly, there are two types of air monitoring in the pharma industry - active and passive.
Active air monitoring is used to sample the air at appropriate surface of culture media. It is then incubated for a fixed time to detect any growth. The growth is analyzed for qualification and qualification of microorganisms.
Passive monitoring is a process to detect microorganism dropped onto the surface without any force. Settle plates are often used to collect the sample, allowing continuous determination of the microorganism in the air. For passive monitoring, settle plates are placed uncovered in the area to be monitored. The plates are placed for a specific time so that microorganisms, if present can drop in the plates containing media. These plates are then placed in an incubator that provides the suitable condition for the microorganism growth. After incubation for a specific time, the plates are analyzed to detect microorganisms.
Personnel is found to be a bigger source of contamination in a clean room. They can easily carry various contamination from outside of clean area, and can disturb the area's quality manufacturing process and product. Even with hygiene practices in place such as gloves, gowns, and masks, personnel can easily become a source of contamination.
To prevent contamination through personnel working in the area, they also require testing and monitoring as a part of the environmental program. Personnel is monitored for contamination at the exit of the critical area (classified area in the buffer, between classified and no classified regions). Two common methods to perform personal monitoring are contact plates and swab analysis.
Contact plates or RODAC plates contain culture media which are generally rubbed on different places of the gown. Some common locations for a gown include
Other areas of the gown that can become prone to contamination can also be taken. The plates are incubated for fixed time and temperature, for analyzing the growth.
Swab analysis is used to swipe different places of gown. After swabbing, it is transferred to a medium containing growth. The medium is then incubated for a specific time and temperature, and is then analyzed to quantify the microorganism.
The surface is also a medium and source of contamination in clean or control areas. Because microorganisms or other contamination can easily be transferred from one surface to another. So if a surface is infected with any contamination, chances are high that the product can take contamination from the infected surface.
Surface monitoring is performed to detect the presence of any containments on its surfaces and to plan subsequent prevention action.
For surface monitoring, every surface near or adjacent to a critical area, product or process are sampled through contact plates and swab analysis.
Like personal monitoring, contact plates are exposed to critical areas for a specific time to collect microorganism in plates, installed for particular time. Plates are then analyzed to detect microorganisms.
Similarly, swab analysis captures any samples of microorganism by swabbing the critical surfaces. The swabs are then transferred to incubator for incubation and subsequent contamination detection. Swab analysis is effective for detecting small items or interior of the critical area.
Also perform surface monitoring in additional areas during operation, other than the mentioned above. For area selection, it depends upon the type of operation being carried out. Additionally, perform surface monitoring randomly throughout the area to detect hidden contamination and its possible sources.
Other parameters in environmental monitoring
Microorganisms are not the only parameter monitored as a part of environmental monitoring in the pharmaceutical industry. Instead, other critical parameters also require monitoring for an effective product compliant environment.
Let’s discuss some of these parameters briefly.
Temperature and humidity
Temperature and humidity are a pharma operation's basic and critical parameters. Its appropriate value is essential for effective product manufacturing, contamination control, and personal comfort.
A pharma product’s chemical composition is determined at specific temperature and humidity levels during development. If these temperature and humidity levels are not provided during manufacturing, the pharma drug will fail to deliver the required therapeutic effect.
Keeping temperature and humidity within limits also helps prevent contamination. Because high temperature and humidity facilitate microorganism growth. Personal comfort is also linked to suitable temperature and humidity, as elevated temperature levels discomfort the personnel working in a critical area.
Temperature and humidity monitoring is performed by the sensor that can detect accurate values. The sensor can then be used to
Display the values in the area for monitoring by personnel and to manually take corrective action of reward.
The sensor can also transmit the temperature and humidity levels to the main controller for automatic adjustment.
These sensors can also record the values for a specific time for later analysis and records.
Airflow monitoring is also an important parameter in environmental monitoring in the pharma industry. it includes monitoring the amount or volume of air flowing in a critical or controlled area
Airflow is monitored because a proper airflow is necessary to remove the air from the used area. Since, air flow occurs with the working of mutually coordinated components, such as
Air inlet fan
Inlet ducting, diffusers, and filters
Outlet airflow, diffusers, and filter
Any change in the airflow directly indicates a problem or fault in any of the components, which also helps to solves the problem, if detected.
Airflow monitoring is performed by flow sensors installed at various locations in a control or critical area. Depending on the area requirement, product type, and application, multiple types of airflow sensors can be used.
Airflow in the Pharma facility continuously monitors the airflow. If there is a deviation in airflow, it signals feedback to the air handling unit to compensate for the difference. Some air flow sensors only give an alert to the concerned personnel.
Another parameter, common in pharma industry is called differential pressure. It is the difference in pressure between two areas measured by taking inputs from respective regions through different tubes.
Differential pressure provides output of a pressure in different areas. The instrument or sensor automatically performs the difference and displays the result as a differential of both inputs.
Differential pressure monitoring is effective and critical in areas where contamination control is necessary. Contamination control is achieved by limiting airflow from dirty to clean areas, which is then monitored through a differential pressure monitor.
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.