Online monitoring system for bio pharmaceutical clean room (room) environment
With the continuous development of the biopharmaceutical industry, the demand for dynamic environmental monitoring of clean rooms is growing. Especially in the monitoring of key indicators such as suspended particles and planktonic bacteria, the standards are becoming more stringent and the requirements are becoming higher and higher. Therefore, more and more biopharmaceutical companies have begun to introduce online environmental monitoring systems to achieve all-weather environmental monitoring. Are you curious about how the online monitoring system of the clean area environment can help biopharmaceutical companies achieve efficient environmental control? Shanghai Raison Optoelectronics will unveil the mystery of this system for you and find out! “Nonviable particle monitoring with a remote counting system is generally less invasive than the use of portable counting units and provides the most comprehensive data.” “A continuous measurement system should be used for monitoring the concentration of particles in the grade A zone, and is recommended for the surrounding grade B areas.” “And it‘s really the root cause investigations that companies really need to improve upon,…” Remote online particle counter 0.3 0.5 micron Online Bacteria Sampler Designed for the biological and electronic industries, the Rasen Online Planktonic Particle Counter is an ideal sampling option with its flexible, continuous, trouble-free operation capabilities. It supports local or remote operation and is made of 316L stainless steel, providing excellent sampling flexibility. Its compact design enables "plug and play" and can be quickly integrated into real-time monitoring systems. It is suitable for clean rooms, biosafety cabinets, laminar flow benches, and other scenarios to meet GMP compliance monitoring needs. Central vacuum pump Vacuum central pump
In the pharmaceutical production process, the production environment and personnel operations play a vital role in the quality of drugs. Air cleanliness is an indicator of the content of suspended particles in the environment. The fewer the number of suspended particles, the higher the cleanliness. Countries around the world have formulated corresponding cleanliness standards to regulate the production environment. my country's GMP divides air cleanliness into four levels: A, B, C, and D. Enterprises need to determine the sampling location for daily dynamic monitoring and conduct dynamic monitoring based on the cleanliness level, air purification system confirmation results and risk assessment. In the A/B grade clean area, dynamic monitoring is an important means to evaluate whether the clean room has reached the specified cleanliness. It is also a key tool to ensure the continuous stability of the production environment and ensure the release of sterile drugs.
The online monitoring system can monitor the cleanliness in real time, monitor the on-site environment, issue pre-alarm and alarm signals in time, display the fault status, and help enterprises quickly discover problems and take effective measures to solve them. The system can also generate environmental parameter reports to reduce risks in the pharmaceutical production environment. It can be seen that the dynamic monitoring of clean areas (rooms) is inseparable from the online monitoring system, and its role is indispensable.
* Online particle counter operates continuously and without any faults.
* Real-time upload of online particle counter data records system faults,
* environmental monitoring alarms, etc.
* User three-level authority audit tracking function
Sampling points
1. Key production areas: Class A areas are high-risk areas where air contact is most critical during the production process, such as bottle delivery, bottle sorting area, before filling, freeze-dried powder injection, and before rubber stopper capping. These areas need to be monitored to ensure the cleanliness of the production environment.
2. Monitoring distance: The monitoring point should be set at a distance of about 1 foot (30 cm) from the high-risk operation point to accurately capture environmental changes in key areas.
3. Avoid turbulent areas: When arranging points, try to avoid locations that are prone to turbulence to avoid affecting the accuracy of monitoring results due to airflow interference, and reduce potential impacts on the production environment.
4. API environmental monitoring: For the API production environment, monitoring points need to be set up at the upper and lower positions respectively, so as to observe the changes in dust in dynamic and static environments at the same time.
5. Reasonable distribution of samplers: The layout of samplers should be uniform and reasonable to ensure that the production area can be fully covered and the entire environment can be effectively monitored.
System software introduction
• Open architecture design: The open architecture is flexible and compatible, and it is easy to integrate a variety of devices and modules to meet diverse needs.
• Modularity and scalability: The system adopts a modular design, and users can flexibly configure and expand modules as needed, which is convenient for upgrading and expansion.
• Real-time data visualization: The system displays data in real time and intuitively presents monitoring results in the form of graphics, tables, status and floor plans, so that users can quickly grasp the environmental status.
• Historical data query function: Users can query historical data at any time, trace monitoring records, and assist in data analysis and decision-making.
• Large-capacity data storage: The system has strong storage capacity and can store massive monitoring data to ensure data integrity and traceability.
• Diversified data output: Supports multiple data output formats, which is convenient for users to export data for further analysis or report generation.
• Automatic alarm mechanism: When the monitoring data exceeds the preset threshold, the system will automatically trigger an alarm to remind users to take measures in time.
• Automated report generation: The system can automatically generate monitoring reports, saving user time and improving work efficiency.
• System security guarantee: A secure login mechanism is adopted to ensure the authority control and data security of system operations.
• Comply with regulatory requirements: The system design complies with the requirements of 21 CFR Part 11 and meets industry compliance standards
LASENSOR one-stop solution
LASENSOR PHOTOELECTRIC CO.,LIMITED is an ISO9000 quality management system certified enterprise with high-quality after-sales service. It provides customers with prototypes to ease the waiting period for customers to repair their machines. The company has its own Class A (Class 100) clean room as a place for maintenance, calibration, and experiments, providing customers with absolute calibration of particle counter offline/online models.
1. Particle monitoring system: Provided by Raison Optoelectronics, from preliminary scheme design to project implementation, verification, calibration, and after-sales, full guarantee
2. Portable counter, floating bacteria instrument: Provided by Raison Optoelectronics, instrument selection consultation, instrument equipment, calibration certificate, calibration after-sales;
3. Industry software: Provided by Raison Optoelectronics, scheme design, customized research and development, implementation training, verification service, and after-sales service.
The software function
The system is responsible for the definition, implementation and testing of the online dust particle monitoring system in the user's production area, and has the following core functions:
1. Remote control function: remote real-time monitoring, alarm setting, data storage, report editing and print output are realized through software in the control room.
2. Particle monitoring function: using particle counters such as LPC-310A and LPC-510A (0.3, 0.5 microns, 28.3 liters/minute) to realize online particle monitoring.
3. Planktonic bacteria monitoring function: through the online planktonic bacteria collection of 28.3L/M flow, real-time monitoring of planktonic bacteria.
4. Environmental monitoring function: monitoring temperature and humidity, and can connect to environmental parameters such as wind speed, thermometer and hygrometer, pressure difference, etc.
5. Sound and light alarm function: with multiple alarm functions such as sampling flow, communication failure, value exceeding the standard, hardware failure, etc., reminding in the form of sound and light to ensure the stable operation of the system.
6. Flow monitoring function: real-time monitoring of the operating flow of each particle counter, showing whether the flow status is normal.
7. Continuous monitoring function: The particle counter can run 24 hours a day in a sterile environment, with built-in flow monitoring function
High-quality design of the remote sensor series laser particle counter, designed for 24/7 operation. Using the latest optical particle monitoring technology, with 0.1 micron sensitivity and 28.3 L/min flow rate, it supports real-time data collection and is cost-effective. It provides two options: external vacuum source and internal pump, and the miniaturized design is suitable for installation in limited space.
LPC-510A realizes continuous real-time data collection, stable and reliable performance, and each monitoring point has excellent accuracy and reliability at an affordable price. Its rugged housing and excellent sealing support VHP disinfection and meet industrial purification standards
Absolute pressure: 150-1000mbar
Relative humidity of air: 30-90%
Note: Not suitable for high humidity, water vapor, corrosive gas, dangerous mixed gas and oil mist environment
The equipment should be checked after the first 8000 hours of operation
Blade condition
Recheck every 8000 hours thereafter
Online monitoring system construction, real-time monitoring system, 24-hour sound and light alarm, particle floating bacteria distribution
linayjiao@lasensor.com
Whatsapp:+ 8615000211360