Wednesday, May 29, 2024

Understanding Sterile and Non-Sterile Facilities and How Environmental Monitoring Helps

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Among pharmaceutical manufacturing sites, vaccinations and other directly injectable medications are considered the most fragile products. The use of sterile and contaminant-free equipment in an environment free of dangerous particulates and with ambient temperatures carefully monitored is critical for products to be used in the human body. Other products, like tablets or orally administered solid-form drugs, are also manufactured in pharmaceutical facilities–but don’t require the same level of scrutiny.  

These two types of facilities for manufacturing, production, and distribution are sterile and non-sterile facilities. Read on to learn more about these sites.

Sterile Facilities and Non-Sterile Facilities

The sterile products include substances that directly enter the bloodstream and need to be free from all viruses, bacteria, fungi, and other contamination. Facilities that manufacture these products are called sterile facilities. 

Non-sterile products, on the other hand, are elements that do not enter the bloodstream directly. These include products like certain tablets, capsules, ointments, and medical devices such as the oximeter. Facilities that manufacture these products are commonly known as non-sterile facilities. 

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What is Environmental Monitoring?

According to Dickson Data, environmental monitoring is the process of systematically collecting and recording relevant environmental data over time. Environmental monitoring harvests data on  any environmental changes that could be detrimental to the manufacturing of a product and lead to poor product outcomes. This data collection occurs in a standardized manner.

When dealing with products and facilities as crucial and delicate as sterile and non-sterile in the pharmaceutical sector, there can be no compromise on the quality standards and hygiene maintained during the procedure. The slightest degradation or variation in temperature, humidity, gaseous ratios, etc., can lead to poor outcomes for the product’s quality and the well-being of its users or consumers. 

However, the problem extends beyond poorly manufactured products. Many manual and technical work hours are void if the environment negatively impacts the final product. For instance, if a product is rendered unfit for use because of lowered hygiene standards, gas exchange, or temperature, the wastage of the product can cause the manufacturing company heavy financial losses. 

One of the most effective measures for improving sterile and non-sterile facilities is monitoring the environment. Digitally empowered tools like data loggers can very effectively monitor the environment in a sterile or non-sterile facility and their data can be used to avoid any conditions that might lead to degradation in the products’ quality.

By setting a data logger to monitor environmental elements like temperature, CO2 levels, pH levels, bacteria or other contaminants, manufacturing conditions can be controlled and maintained. It is essential to have a standardized system to readily measure each vital parameter in a set time to ensure the highest standards of quality and efficacy are maintained. 

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How can we monitor the environment?

Organizations and governments take many measures, and the general public of all current generations is taking initiatives to monitor and respond to environmental threats around the globe today. There are a lot of technologies like data loggers supporting the environmental monitoring mission indoors and outdoors. 

Data loggers are a significant and helpful tool for environmental monitoring in the manufacturing, healthcare, and pharmaceutical industries. They are accurate, reliable, and can transmit your data to the cloud or to your phone. They can be programmed to collect and arrange the data they collect in tables and graphs, for easy analysis and understanding by concerned researchers,  managers, or lay people who are charged with keeping a watchful eye on conditions.

Depending upon the user, data loggers are of different types. Wi-Fi, Bluetooth, and USB are some examples of their wide variety. This variety is subjective to the user on how they can install them at the monitoring site. 

Benefits of Environmental Monitoring

Environmental monitoring is crucial for companies manufacturing sterile and non-sterile products. The concern for these companies is not just the product’s health but also the health of the staff who work on the manufacturing line. 

Data loggers monitor the environment systematically. They can immediately detect any temperature excursions from allowed parameters. Some data loggers are designed with an alarm that goes off when any parameter goes out of the criteria defined in a data logger. This alert can notify the right employees who can then take action to address the issue. This helps prevent product quality degradation and maintain health and purity standards. 

The world is becoming increasingly cautious of the environment, indoors and outdoors. 

Sterile and non-sterile facilities are incredibly vulnerable to environmental conditions. These facilities must maintain appropriate environmental conditions to uphold the highest quality standards. Using technologies like data loggers is the best method to protect and ensure 100% reliability in manufacturing products. 

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