Environmental monitoring has become a common practice across numerous industries. It has become a means of regulating the safety and security of products, people, and other commodities in the concerned space.
Environmental monitoring has significantly impacted industries like food and beverages, pharmaceuticals, urban planning, and healthcare.
Why is environmental monitoring essential?
Comprehensive environmental monitoring allows the user to monitor factors of concern like humidity, air quality, CO2 levels, UV light, and airflow. These regulate the switching on and off of HVAC (heating, ventilation, and air cooling). Monitoring these conditions help predetermine thresholds for BMS (building management systems). Additionally, environmental monitoring helps conserve energy, create a secure environment, and keep a data log of the environmental components of a space.
What is environmental monitoring for medical facilities?
Environmental monitoring is an essential process for quality control. Environmental monitoring refers to the processes utilized for observing an environment. The observations help characterize the environment’s quality and ensure that it meets all established and accepted criteria. In the medical world, products and devices need to meet specific acceptance criteria to sustain their integrity, and environmental monitoring assists with the same. It ensures the products remain effective and safe throughout their lifecycle, from the raw stages to their end-use or expiration date.
What is a non-sterile facility?
Non-sterile facilities are the opposite of aseptic facilities, i.e., facilities that are entirely kept free from bio burdens or unwanted and harmful elements. In a non-sterile facility, environment maintenance focuses on controlling the safety levels based on product attributes, administration routes, and the target consumer population.
The environment is kept clean and pure but not to a level where an aseptic sterile environment is maintained. No specialized equipment is employed in a non-sterile facility to prevent microbial materials. However, environmental monitoring assists in sampling and detecting spaces, elements, and conditions that might be prone to contamination or harmful effects.
Why is environmental monitoring for non-sterile facilities and processes essential for medical products?
The microbial content in non-sterile products is regulated to a level that the patient requires for their safety within the secure parameter range of the products’ use. Controls for excessive sterility processing can add more complexity and cost without any safety benefits. Eliminating unnecessary sterility or aseptic processes helps the manufacturers and patients save money.
The non-sterile processing methods are advantageous for use depending upon the end use of medical products. The management and manufacturing of non-sterile facilities and products and their microbial contents are different from sterile products and facilities. The non-sterile processing methods are advantageous for use depending upon the end use of medical products. Most products are applied topically or injected into sensitive tissues. These involve a high risk of infection without any barriers or little flora.
Contrasting sterile environments and products, non-sterile components are administered to regions of a human body with a high density of natural microbial flora with physical and immunological barriers against infection. Despite the security contrast between sterile and non-sterile components, the manufacturing and management of non-sterile components must be maintained to prevent excessive contamination. This prevention occurs by limiting the microbial chain of infection.
Environmental monitoring involves sampling, swabbing, analysis, and administration of different sites and elements of a non-sterile space to ensure an adequate balance between product efficacy and safety. The microbial growth in excipients, drug substances, and components is monitored comprehensively and acts as the most significant factor of concern for non-sterile products. It prevents huge losses by curbing contamination, spoilage, and large-scale waste.
How to monitor the manufacturing environments for non-sterile products
Environmental monitoring of non-sterile products is a qualitative method for minimizing the risk of microbial contamination in them. The effectiveness of microbiological controls is confirmed by successful environmental monitoring that detects unforeseen contamination issues. This detection happens before the contamination takes a severe form and wastes resources and money.
The level of human activity and requirements of the facility decide the levels of transient contamination. This is because maximum microbial contaminants introduced in clean environments come from humans. With non-sterile products, the manufacturers expect bio-burden levels, so they do not risk the end user.
To monitor the manufacturing environments for non-sterile products, the manufacturers must institute acceptable levels of microorganisms. They need to perform regular assessments for plant hygiene to maintain the efficacy of the microbial environment control of the facility. Microbial sampling and staff evaluation contribute to raw material assessments and evaluations for cleaning protocols.
How do you test the manufacturing environments for non-sterile products?
Environmental monitoring of non-sterile manufacturing facilities happens with the help of both active and passive sampling methods. One such method is air sampling, which uses a functional device sample with the help of air volume and captures viable organisms found on solid media plates. The results of this active sampling device are in the form of colony-forming units per unit volume.
Passive sampling happens through settling plates. These are based on the time in the manufacturing facility against the sampled air volume. The characterization of cellular morphology, microorganisms, and diagnostic testing are employed for non-sterile hygienic assessments for assessing their contamination.
As Dickson Data suggests, environmental monitoring is an excellent tool for maintaining compliance while monitoring critical conditions of a specific space. From security maintenance at workplaces and manufacturing centers to cold chain facilities and sterile/non-sterile components, environmental monitoring is a constantly growing trend that’s adding more value to various sectors.
The contamination control in non-sterile facilities is distinct from that of sterile facilities. However, environmental sampling is instrumental in both scenarios with different levels of regulations.