Air Quality Experts: Non-Viable Monitoring Specialists

Non-viable air monitoring is a process that uses particle counters to measure non-living particles in the air. This method of air sampling is commonly used in industries such as biotechnology, medical device manufacturing, pharmaceuticals, and hospital pharmacies to ensure the cleanliness and maintenance of rooms and manufacturing areas. Non-viable air monitoring is particularly important in aseptic processing and cleanroom environments, where contamination can have serious consequences for product sterility and patient safety. The process involves collecting air samples using a tape, filter membrane, or sticky surface, which are then examined under a microscope to identify and quantify the particles. This technique is often favoured over viable air sampling due to its speed and ability to detect real-time changes in the environment.

Non-viable air monitoring is used in industries such as biotechnology, medical device manufacturing, and pharmaceuticals

Non-viable air monitoring is a critical process in industries with strict standards for product quality and safety, such as biotechnology, medical device manufacturing, and pharmaceuticals. These industries rely on non-viable air monitoring to ensure their manufacturing environments remain sterile and free from harmful contaminants.

Biotechnology

Biotechnology companies often work with sensitive biological materials that require a sterile environment to prevent cross-contamination. Non-viable air monitoring is used to detect and measure airborne particles that could compromise the integrity of their work. By continuously monitoring the air quality, biotechnology firms can maintain the high standards necessary for their research and development activities.

Medical Device Manufacturing

In the medical device manufacturing industry, non-viable air monitoring is essential to ensure the safety and effectiveness of their products. Medical devices, such as implants, surgical instruments, and diagnostic equipment, must be produced in cleanrooms that adhere to stringent standards. Non-viable particle counters help manufacturers maintain these standards by detecting and counting particles in real time, allowing them to take immediate corrective actions if needed.

Pharmaceuticals

The pharmaceutical industry is highly regulated, and manufacturers must ensure that their products are safe and sterile. Non-viable air monitoring is used to verify the absence of particles that could contaminate pharmaceutical products during the manufacturing process. By monitoring particulate matter, pharmaceutical companies can maintain the required level of cleanliness in their cleanrooms, ensuring that their products meet the highest standards of quality and safety for consumer use.

Non-viable air monitoring plays a crucial role in these industries by providing a rapid and effective means of detecting and measuring airborne particles. While traditional viable air sampling methods can take days or weeks to deliver results, non-viable particle counters offer real-time data and enable immediate corrective actions. This proactive approach helps maintain the integrity of products and ensures compliance with strict industry regulations.

Non-viable air monitoring is faster than viable air sampling, which can take days or weeks

Non-viable particle counting, on the other hand, occurs in real time. By using a system of lasers, reflectors, and photoreceptors, non-viable particle counters can detect, measure, and count airborne particles instantly. This modern method provides faster turnaround times as culturing and growth are not required.

The speed of non-viable air monitoring is particularly advantageous in settings such as hospital pharmacy cleanrooms, where the number of pathogens can increase rapidly, and timely corrective action is crucial for patient safety. With non-viable particle counting, pharmacy staff can be alerted to a rise in contaminants immediately, rather than days or weeks later when it may be too late.

Additionally, non-viable air monitoring systems are becoming increasingly automated, further enhancing their speed and efficiency. These modern systems can be permanently installed, reducing the need for human operators and potential disruptions to airflow and sterile environments. The automation of non-viable particle monitoring not only improves the speed of data collection but also ensures more consistent monitoring that adheres closely to standard operating procedures.

The faster turnaround times of non-viable air monitoring make it a valuable tool for tracking changes in air quality over time or after interventions. This real-time data enables professionals to take prompt action to address potential contamination and effectively manage their environments.

Non-viable particle counters use lasers, reflectors, and photoreceptors to detect, measure, and count particles

Non-viable particle counters are used in cleanrooms to count and size the particles in the air so the room can stay in proper working function and meet crucial certification criteria. They are also used to detect, measure, and count particles in hospital pharmacy cleanrooms.

Non-viable particle counters use a system of lasers, reflectors, and photoreceptors to detect, measure, and count particles instantly. The laser sensor block inside the particle counter contains a sample view volume, sensor cavity, and optics. The sample view volume is the area where particles pass through the laser and scatter light. The sensor cavity and optics allow the particle counter to move air through the sensor block and detect the size of the particle through light scattering.

As air is pulled into the particle counter through the inlet, it passes through a laser diode and reflects light, causing light scattering. The larger the particle, the more light is reflected. A photodetector then converts the light energy into a voltage signal, allowing the physical size of the particle to be quantified and a particle count to be presented.

Non-viable particle counters are able to detect tiny particles, as small as 0.06 to 0.14 microns, through high-accuracy lasers. For example, the COVID-19 virus is between 0.06 and 0.14 microns, and viruses in general are 0.1 microns.

While non-viable particle counters are able to detect, measure, and count particles instantly, their perceived drawback is their inability to differentiate between non-viable particles (e.g. dust, smoke) and viable particles (e.g. bacteria, viruses, pollen). Despite this, non-viable particle counters have been found to be extremely effective in detecting true contaminants. A 2012 study by the National Institute of Health (NIH) found that non-viable particle counters had a 95.6% chance of detecting a true contaminant, with the probability of a false positive occurring only 1.3 times a year.

In addition, continuous non-viable particle monitoring allows professionals to take control of their environment by implementing an effective early warning system for possible contamination.

Non-viable air monitoring is becoming more automated and important for contamination risk management

Non-Viable Air Monitoring: Automation and Importance in Contamination Risk Management

Non-viable air monitoring, also known as non-viable particle monitoring (NVP) or total particulate monitoring, is a critical aspect of ensuring the quality and safety of products in various industries, including pharmaceuticals, cosmetics, food and beverages. As the process becomes more automated, it plays an increasingly important role in contamination risk management during aseptic processing.

Automation in Non-Viable Air Monitoring

The biopharmaceutical industry is witnessing a shift towards greater automation in aseptic processing, driven by the development of new biologic therapies that require sterile production methods. This trend is also evident in non-viable air monitoring, which is becoming more automated to effectively manage contamination risks. Here are some key aspects of this automation:

• Reduced Human Contact: The leading cause of microbiological contamination in aseptic processing is human contact with sterile products. To mitigate this, new aseptic processing facilities are increasingly utilizing automated equipment, isolators, and Restricted Access Barrier Systems (RABS) to minimize human interaction.
• Improved Airflow and Filtration: Another priority in contamination control is enhancing unidirectional filtered (HEPA) air flow coverage. This includes achieving 100% HEPA coverage for exposed sterile products, reducing the risk of airborne particle contamination.
• Advancements in Technology: Modern non-viable monitoring systems are evolving to improve the detection and management of potential contaminants. These systems employ lasers, reflectors, and photoreceptors to instantly detect, measure, and count airborne particles in real time.
• Permanent Installation: There is a growing trend towards using permanently installed, online, computer-controlled particle counters instead of portable, human-operated counters. This reduces the need for operator presence in Grade A and B areas, minimizing potential sources of contamination.
• Increased Sensor Usage: With the complexity of automated fill/finish operations, particularly those involving lyophilization, there is an increase in the number of particle sensors used. This ensures comprehensive monitoring of all critical points in the production process.
• Recipe-Driven Monitoring: Modern particle monitoring systems are designed to be workflow-based, with sensors controlled based on the specific stage of the operation, such as filling, capping, or lyophilization.
• Batch-Driven Operation and Reporting: Non-viable/viable particle monitoring systems now automatically generate comprehensive batch reports upon completion of the aseptic process. These reports include sample data, statistics, and alarm histories, streamlining the compliance and quality assurance process.

Importance in Contamination Risk Management

Non-viable air monitoring plays a crucial role in contamination risk management during aseptic processing for several reasons:

• Real-Time Data: Non-viable particle counting provides instant results, enabling pharmacy staff to take prompt corrective action in case of increased pathogen levels. This is in contrast to traditional viable air sampling methods, which can take days or weeks to deliver results.
• Detection of Smaller Particles: Non-viable monitoring systems can detect smaller particles that are more prevalent during contamination events. This capability enhances the early detection of potential issues.
• Identification of Risk Sources: By analyzing the root causes of non-viable particle events, it is possible to identify whether the contamination is likely due to human involvement or automated equipment/component malfunctions. This information is invaluable for implementing targeted corrective measures.
• Continuous Monitoring: Non-viable air monitoring systems provide continuous data on changes in the aseptic environment, allowing for prompt detection of contamination events and the implementation of timely countermeasures.
• Reduced Human Intervention: Modern non-viable particle monitoring systems minimize the need for human intervention in isolated Grade A areas, reducing the risk of human-induced contamination.
• Simplified Root Cause Investigations: The data provided by these systems simplifies root cause investigations, making it easier to identify and address sources of contamination.
• Instant Compliance Reports: The automated generation of batch reports eliminates the labor-intensive process of creating compliance reports, saving time and resources for manufacturers.

In conclusion, non-viable air monitoring is becoming increasingly automated and vital for contamination risk management in aseptic processing. By adopting modern technologies and practices, industries can improve product quality, streamline operations, and ensure the safety of their products.

Non-viable air monitoring is useful for detecting real-time changes and events that may compromise aseptic lots

Non-viable air monitoring is a critical component of maintaining air quality in various industries, including biotechnology, medical device manufacturing, pharmaceuticals, medical disposables, and hospital pharmacies. These industries must adhere to stringent regulations regarding the cleanliness and maintenance of their facilities, and non-viable air monitoring plays a vital role in achieving this.

Non-viable air monitoring, also known as total particulate monitoring, is a regulatory requirement during aseptic processing. Aseptic processing is essential in the biopharmaceutical industry, particularly with the increasing focus on new biologic therapies administered via injection or IV. Non-viable particle monitoring (NVP) is crucial for contamination risk management during this process.

One of the key advantages of non-viable air monitoring is its ability to detect real-time changes and events that may compromise aseptic lots. Continuous NVP monitoring provides minute-by-minute updates on count populations and trends, allowing for the prompt identification and quantification of risks. This real-time data helps catch contamination events, ensuring that corrective actions can be taken immediately to protect the product.

Traditional viable air sampling methods, such as using agar strips or plates, can take days or weeks to deliver results. In contrast, non-viable particle counting occurs in real-time using lasers, reflectors, and photoreceptors to instantly detect, measure, and count airborne particles. This real-time analysis allows for early detection of potential issues and enables prompt corrective actions, ensuring the safety and quality of the products.

Additionally, non-viable air monitoring systems are becoming more advanced, with increased automation and computer-controlled particle counters. These modern systems improve consistency, reduce human intervention, and provide comprehensive data for analysis and compliance reporting.

In conclusion, non-viable air monitoring is a valuable tool for detecting real-time changes and events that may compromise aseptic lots. By providing continuous monitoring, immediate results, and data-driven insights, non-viable air monitoring plays a crucial role in maintaining the integrity of sterile products and ensuring compliance with industry regulations.

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