Product development background:
Due to the rapid development of global biopharmaceutical technology and the sustained growth in demand for personalized medicine, it is expected that the biopharmaceutical industry will achieve a growth rate of over 12% by 2025. These demands will drive advanced therapies such as cell therapy, genetic engineering, and antibody drugs in the biopharmaceutical industry into an accelerated industrialization stage. In the production process of biopharmaceuticals, the requirement for a sterile environment is extremely high. In key processes such as cell culture, fermentation, and purification, improving cleanliness can effectively control microbial contamination, thereby ensuring drug quality and safety, and creating significant social and economic benefits.
In the biopharmaceutical production environment, airborne bacteria may contaminate the culture system or final product, leading to:
- 1)Cell therapy products have exceeded microbial standards, resulting in batch scrapping;
- 2)Monoclonal antibody drugs are contaminated with endotoxins, which affects clinical efficacy;
- 3)Vaccine products pose a risk of microbial load, posing a threat to medication safety.
Therefore, using high-precision planktonic bacterial samplers for environmental monitoring has become an important part of implementing GMP quality management in biopharmaceutical companies. By regularly monitoring microorganisms in key areas such as A-class clean areas, isolators, and the vicinity of bioreactors, it is possible to:
- Real time monitoring of environmental microbial pollution levels
- Timely detection and control of pollution risks
- Ensure the stability and reliability of the production process
- Meet the compliance requirements of domestic and foreign regulatory agencies
With the continuous improvement of product quality requirements in the biopharmaceutical industry, the sampling technology of planktonic bacteria is developing towards intelligence and automation to meet stricter requirements for clean environment monitoring.
SX-JCQ-7 Floating Bacteria Sampler - A New Solution for Microbial Monitoring
Product Overview:
The SX-JCQ-7 planktonic bacteria sampler is a high-precision and intelligent microbial monitoring and sampling device that uses microporous inhalation sampling technology and supports dual-mode sampling of "integrated" and "split". It is suitable for sampling in various clean environments and facilitates clean environment monitoring in related production institutions.
Core advantages
1. Flexible sampling design:
The integrated sampling head is directly installed on the equipment base and is suitable for open spaces such as clean rooms and production workshops. It is easy to operate and can be tested immediately.
Integrated sampling head mode
Split type sampling head, connected to air duct equipment, can penetrate into narrow spaces (such as inside pipelines and equipment gaps) to achieve blind spot sampling and solve the problem of blind spots that traditional samplers cannot cover.
Split sampling head mode
2. High precision sampling performance:
Laser precision drilling technology, with 397 holes (Φ 0.7mm), ensures uniform airflow and a particle impact velocity of 10.8m/s, efficiently capturing microorganisms and particles ≥ 1 μ m.
Flow closed-loop self-regulation, stable at 100L/min ± 5%, ensuring data accuracy and complying with ISO 14698-1/2 standard.
3. Intelligent Data Management:
Data storage and traceability, recording sampling data, supporting historical queries.
Audit tracking, automatic recording of operation logs, meeting FDA 21 CFR Part 11 compliance requirements.
Three level permission management, graded control by administrators, technicians, and operators to prevent misoperation.
4. Portable and efficient:
Built in lithium battery pack, free from power limitations, suitable for mobile monitoring.
Low noise design, (<55dB), Provide a quiet working environment that does not affect clean area operations.
5. Diversified data output:
WiFi/LoRa communication ensures secure data transmission.
Bluetooth printer, on-site printing of sampling reports.
USB drive export, supporting CSV/PDF format for easy data analysis and archiving.
6.Humanized operation:
4.3-inch touch screen, intuitive operation interface, simplified process.
Flat dust-free design to avoid dust accumulation and meet the requirements for use in clean areas.
Technical Parameter
Model |
SX-JCQ-7 |
Display screen |
4.3-inch touch screen |
Sample flow |
100L/min ± 5% sampling flow closed-loop automatic adjustment |
Single sampling quantity |
1-6000L |
Sample delay |
User self setting (0-14400 seconds) |
Region management |
Can preset 400 sampling areas and independently save configuration parameters |
Mueller-Hinton agar |
Φ90mm × 15mm |
Vacuum power source |
Imported fan, continuous and stable operation, energy-saving and environmentally friendly |
Compliant with standards |
GMP、ISO 14698-1/2、GB/T 16293-2010 |
User Management |
250 users with independent passwords |
Rights Management |
Third level permissions, data storage and retrieval, printing |
Data memory capacity |
1 to 30000 sets of measurement data and 1 to 60000 sets of audit tracking records can be queried |
Working hours |
Fully charged for continuous testing for 6 hours
|
Charging power supply |
AC power(220V/50Hz) |
Built in lithium battery parameters |
DC14.8V 6.6Ah |
Charging adapter parameters |
Input 100V-240V 1.3A,output 24V 3.75A |
Battery charging time |
6-8 hours |
Data communication interface |
RS485: Modbus RTU protocol |
Ethernet: Modbus TCP/IP protocol |
|
USB:USB interface communication protocol |
|
Environment requirements |
Usage environment: Temperature 0~40 ℃, relative humidity 10~70% RH |
Storage environment: Temperature -30~45 ℃, relative humidity 0~90% RH |
|
External dimensions |
Length 200 x Width 274 x Height 190 (mm) (including handle and external interface) |
Material |
AL6061 anodized aluminum alloy |
Power |
20W |
Weight (including battery) |
3.3kg |
Other accessories |
RS485 terminal, power adapter, Bluetooth printer
|
Warranty |
1-year warranty, optional extended warranty service
|
Application field
Pharmaceutical industry: A-level clean area, sterile filling line, isolator monitoring
Medical field:operating room ICU、 Laboratory biosafety cabinet
Food production:Microbial control in filling workshop and fermentation area
Electronic Manufacturing:Semiconductor Cleanroom, Nanomaterial Production Environment
Environmental Monitoring:Assessment of Air Microbial Pollution
Why choose SX-JCQ-7?
Industry compliance: Compliant with international standards such as GMP and ISO 14698, suitable for high specification clean environments.
Intelligent and efficient:Automated sampling, data traceability, and reduced manual errors.
Flexible adaptation:integrated+split dual mode to meet different space requirements.
Safe and reliable:Audit tracking+permission management to ensure data integrity.
SX-JCQ-7- provides accurate, intelligent, and flexible solutions for microbial monitoring!