In the pharmaceutical industry, maintaining a clean and sterile environment is paramount to ensuring product quality and patient safety. To achieve this, cleanrooms are utilized, and one of the key components in maintaining their cleanliness is effective air monitoring. Among the various methods used for air monitoring, active air sampling is commonly employed. This method involves using an Air Sampler to collect a predetermined volume of cleanroom air.

To sample the viable particle in a cleanroom area, the Microbial Air Sampler collects an established volume of cleanroom air onto a petri dish containing a culture medium. The plates are then incubated under appropriate conditions, and the resulting colonies are counted and calculated using Feller’s conversion table.

This blog will delve into the physical attributes, working principles, and invaluable benefits of the Microbial Air Monitoring System (TME 005) in the pharmaceutical industry.

Physical Attributes

The Microbial Air Monitoring System (TME 005) boasts impressive physical attributes that make it an ideal choice for pharmaceutical industries. Constructed from lightweight and hard durable plastic, it is both easy to operate and carry. To ensure proper sampling coverage without the need for manual adjustments, a convenient clamp for petri plates is incorporated into the system. The system’s motor utilizes centrifugal force to draw air, maximizing sampling efficiency. Moreover, the system offers a remarkable battery backup of 8 hours and can be fully charged in just 4 hours.

Working Principle and Sampling Process:

The Microbial Air Monitoring System (TME 005) employs an intuitive user interface and advanced technology to streamline the sampling process. Upon turning on the device, you gain access to the main menu, which consists of three tabs: run, settings, and data. To ensure data security and traceability, the system supports multiple users with individual login credentials.

Within the settings menu, accessible to administrators and supervisors, various parameters can be configured, including sampling parameters, time, language, print settings, and connectivity. Administrators and supervisors have the flexibility to set the sampling location, sample volume, and delay time, optimizing the system for specific cleanroom requirements. Furthermore, administrators and supervisors can create up to 6 pre-set tabs, eliminating the need for repetitive parameter input during each sampling cycle, thus saving valuable time. With a fixed flow rate of 100 litres per minute, the system ensures consistent and accurate air sampling. The system shows a real-time flow rate, and it will replicate the sample time accordingly. Maintaining a disturbance-free environment is crucial, as any disruptions during sampling can impact the flow rate.

 

Benefits in the Pharmaceutical Industry:

1. Improved Workflow and Productivity

With its lightweight construction and user-friendly interface, the Microbial Air Monitoring System (TME 005) simplifies operation and enhances workflow efficiency. The hard durable plastic is easy to carry and disinfect. Its ability to withstand disinfectants, such as Isopropyl Alcohol (IPA), coupled with its smooth surface, ensures minimal particle retention in the sampling area, resulting in highly accurate results. The system’s user-friendly interface has a 5-inch touchscreen display and is as simple to use as an android phone. The intuitive menu layout and easy-to-navigate settings ensures a smooth and hassle-free sampling process. By minimizing the time spent on manual adjustments and repetitive tasks, the system allows laboratory personnel to focus on other critical responsibilities, increasing overall productivity within the clean room facility.

2. Enhanced Accuracy in Sampling:

By utilizing the advanced Microbial Air Monitoring System (TME 005), pharmaceutical companies can effectively monitor and control the presence of viable particles in the air. The system’s protective lid and autoclavable stainless-steel sampling head ensure sterility during operation, minimizing the risk of contamination. As the system can be easily disinfected it ensures that all the sample collected on the plate is from cleanroom air not from the system. The unique slit design of the sampling head increases the volume of air sampled while maintaining a vortex motion, optimizing sample collection efficiency. These features result in accurate assessments of microbial presence, enabling companies to identify potential contamination sources promptly. With this information, proactive measures can be taken to maintain the highest standards of product quality, safeguarding patient safety.

3. Real-time flow rate and Alert System:

The Microbial Air Monitoring System (TME 005) provides real-time monitoring of the sampling process by providing real time flow rate. This feature enables immediate detection of any irregularities or deviations, such as changes in flow rate or disruptions during sampling. If the interruption in the flow rate continues, the instrument automatically discontinues the sampling.

4. Individualized User Access and 3 level authorities:

The Microbial Air Monitoring System (TME 005) supports unlimited users with individual log-in credentials, ensuring data security and fostering a sense of accountability among users.

By assigning specific access levels, such as user, supervisor, and admin, companies can maintain control over data management and system configuration. Users can run sampling only, supervisors have access to the settings menu and can modify sampling parameters, assign users, and perform various other functions. Admins, in addition to supervisor actions, can change system time or erase data entries. This multi-tiered authority management system enhances operational efficiency while protecting sensitive data.

5. Regulatory Compliance:

In the highly regulated pharmaceutical industry, compliance with standards and regulations is paramount. The Microbial Air Monitoring System (TME 005) is designed specifically to meet the stringent requirements of ISO 14698 standards, ensuring cleanroom integrity. Moreover, the system’s data collection software complies with 21 CFR Part 11, a crucial regulation governing electronic records and signatures. Adhering to these standards empowers pharmaceutical companies to confidently meet their regulatory obligations and maintain the highest level of quality assurance.

6. Seamless Data Management:

Efficient data management is essential for effective monitoring and analysis. The Microbial Air Monitoring System (TME 005) offers pharmaceutical companies seamless data management capabilities. The system has a data storage capacity of 10,000 records. The user-friendly interface provides administrators with a centralized data query interface and an audit trail feature.

a. Audit Trail Feature

The Microbial Air Monitoring System (TME 005) offers comprehensive traceability and documentation features, ensuring compliance with regulatory requirements and facilitating thorough record-keeping. The system’s audit trail feature records all user activities and changes made to parameters, providing a transparent and auditable history of sampling procedures. This traceability enhances accountability, simplifies regulatory audits, and supports a culture of quality assurance within pharmaceutical companies.

b. Data Export

To facilitate integration with existing laboratory information management systems (LIMS), the system offers multiple methods for data export, including Bluetooth, Wi-Fi, LAN, and USB. This comprehensive data management approach enables thorough analysis and reporting, enabling companies to make informed decisions based on reliable data.

7. Time and Cost Efficiency:

The Microbial Air Monitoring System (TME 005) optimizes the air monitoring process, leading to improved efficiency in terms of time and cost. Advanced features such as pre-set tabs and a fixed flow rate minimize manual input and ensure consistent sampling. The system’s substantial data storage capacity of 10,000 records allows for extensive sampling without the need for frequent data clearing. This not only saves time but also reduces costs associated with manual data management, enhancing productivity and resource allocation within the pharmaceutical industry.

8. Add-On Accessories:

The Microbial Air Monitoring System (TME 005) comes equipped with additional accessories such as a Stylus, User Manual, Additional Sampling Head, and a Bluetooth Thermal Printer. The Bluetooth Thermal Printer allows users to conveniently print their sampling data on-site, providing real-time documentation of results for immediate analysis and decision-making.

In summary, the Microbial Air Monitoring System (TME 005) offers a range of invaluable benefits for the pharmaceutical industry. From its sturdy physical attributes and user-friendly interface to its advanced technology and seamless data management capabilities, this system empowers pharmaceutical companies to maintain cleanroom integrity, ensure product quality, and comply with regulatory standards. By investing in the Microbial Air Monitoring System (TME 005), pharmaceutical companies can optimize their contamination control processes, streamline operations, and contribute to the well-being of patients worldwide.