SUZHOU, China – November 20, 2025 – Suzhou Sujing Instrument Automatic Control Equipment Co., Ltd. (“Suzhou Sujing”) was honored to welcome a high-level delegation from TESSOL, Inc., a leading South Korean provider of measurement and validation solutions, on November 19, 2025.
The visiting delegation included TESSOL’s CEO, the Sales Director, and the Head of Calibration & Validation. The visit aimed to evaluate Suzhou Sujing’s manufacturing capabilities and discuss potential strategic collaborations to expand market reach in South Korea.
Caption: Executives from TESSOL and Suzhou Sujing pose for a group photo at the company headquarters.
Showcasing Manufacturing Excellence
During the visit, the TESSOL team was given an extensive tour of our manufacturing workshops. As experts in the fields of validation and calibration, the guests paid close attention to our production environment, assembly precision, and rigorous quality control processes.
The tour highlighted Suzhou Sujing’s core product lines, with a specific focus on:
Air Particle Counters
Liquid Particle Counters
Photometers
Surface Particle Counters
Caption: TESSOL representatives inspecting the production line and examining the technical details of our particle counters.
High Praise and Future Cooperation
Following the facility tour, the two parties held an in-depth business meeting. TESSOL’s technical leadership expressed high approval of our equipment, noting that the performance and accuracy of Suzhou Sujing’s instruments meet the stringent requirements of international standards.
Given TESSOL’s strong foothold in the Korean pharmaceutical, biotech, and semiconductor sectors, their CEO expressed a strong intention to purchase our equipment and establish a long-term partnership. Both sides agreed that combining TESSOL’s validation expertise with Suzhou Sujing’s advanced instrumentation creates a powerful synergy for the market.
Caption: Senior leadership from both companies discussing strategic partnership opportunities during the meeting.
Looking Ahead
This visit marks a significant milestone in Suzhou Sujing’s international expansion strategy. We look forward to a fruitful partnership with TESSOL, bringing our high-quality cleanroom testing solutions to a broader range of customers in South Korea and beyond.
Why Data Consistency Is Becoming a Key Issue in Cleanroom Monitoring
In the European pharmaceutical sector, cleanroom environmental monitoring is no longer judged only by whether a sample has been collected. In aseptic production areas, critical clean zones, and other controlled environments, manufacturers are paying closer attention to whether the sampling process is stable, the records are traceable, and the results remain comparable across locations and monitoring cycles. That is why data consistency in viable air sampling is becoming a central topic in equipment evaluation and environmental monitoring strategy.
In practice, inconsistent results rarely come from one single factor. More often, they are linked to a combination of issues such as unstable sampling flow, inconsistent operator practice, incomplete record management, or sampling head designs that do not match the airflow conditions of the monitored area. In the European market, these issues are increasingly assessed within stricter environmental monitoring and documentation expectations. As a result, buyers are giving more weight to whether a viable air sampler can support repeatable and controlled sampling under routine cleanroom conditions.
What Affects Viable Air Sampling Results in Pharmaceutical Cleanrooms
For active air monitoring equipment, consistency is not simply about how fast a unit can collect air. What matters more is whether the sampling parameters, structural design, and data handling logic can support repeatable use.
Is the Sampling Flow Stable?
Sampling flow is one of the most important factors affecting result comparability. If airflow changes across different locations, operating periods, or power conditions, the sampling data becomes harder to compare. The FKC-V viable air sampler, for example, is specified at 100 L/min ±5%. This type of parameter is more useful in technical communication because it defines a clear operational range rather than relying on vague claims of performance. For pharmaceutical cleanrooms, measurable flow control is closely linked to standardized monitoring practice.
Does the Sampling Method Support Representative Collection?
Representative sampling is equally important in controlled environments. The FKC-V is designed based on the principle of isokinetic sampling and uses a SUS316L slit sampling head. This design is intended to keep the air velocity at the sampling inlet aligned with cleanroom airflow conditions while helping airborne microorganisms impact the agar surface more evenly. For pharmaceutical users, such design details are not just product features; they are part of the technical basis for sampler selection.
Are Records Traceable and Usable?
In Europe, the value of environmental monitoring equipment increasingly depends on how well it supports traceable records. User authority management, audit trail functions, on-site printing, and data output options all matter in routine quality review. If a sampler can collect air but cannot support a clear record trail, its usefulness in long-term environmental monitoring is limited.
What Should European Buyers Focus on When Selecting a Viable Air Sampler?
From an industry perspective, pharmaceutical cleanrooms in Europe should pay close attention to four areas: whether the sampler provides clear and verifiable flow specifications, whether it supports flexible sampling volume settings, whether the material and structure are suitable for cleanroom use, and whether the unit supports traceable documentation.
In this context, the FKC-V’s 1–9999 L adjustable sampling volume, SUS316L sampling head, real-time flow feedback, and multi-level user management with audit trail are more relevant when discussed as part of standardized monitoring workflow rather than as generic selling points. For B2B websites, this approach also aligns better with Google SEO and AI indexing because it reflects real application scenarios, technical parameters, and buyer concerns instead of relying on promotional language.
Conclusion
For European pharmaceutical cleanrooms, the focus of viable air sampling is shifting from simply completing a monitoring task to building a system that is consistent, traceable, and review-ready. In both product positioning and content strategy, discussing sampling flow, representative collection, material design, and record integrity is far more persuasive than broad claims about advanced performance. For overseas B2B search behavior, this parameter-based and application-driven framing is also more likely to attract sustainable search traffic.
Compliance Pain Points in Pharmaceutical Particle Testing
In the Indian and global generic drug export markets, the quality control of injectable drugs and pharmaceutical packaging faces rigorous regulatory scrutiny. Traditional liquid particle testing often relies on manual recording or non-compliant software systems. When confronting the mandatory requirements of FDA 21 CFR Part 11 regarding "electronic records and signatures," this easily triggers audit risks. The lack of traceable audit trails and strict user privilege classification has become a core pain point for many pharmaceutical companies during equipment selection.
Electronic Compliance Architecture of the LE100S
To overcome this compliance hurdle, the LE100S Intelligent Liquid Particle Counter, introduced by Suzhou Sujing Instrument & Control Equipment Co., Ltd., provides a comprehensive solution. This equipment features built-in LE-Assistant software, which fully complies with FDA 21 CFR-11 rules from its underlying architecture. The system supports multi-level user privilege management and operation log traceability, offering professional paperless electronic report output. Via a USB interface, protected data can be directly exported, and the device can easily connect to Laboratory Information Management Systems (LIMS), eliminating data silos and ensuring data integrity.
Data-Driven Reliability and High Precision
Beyond software compliance, hardware stability is the cornerstone of consistent test results. The LE100S demonstrates exceptional reliability through its technical parameters:
Core Specifications: Supports a broad particle size detection range of 2-600 μm, with system accuracy maintained within ±10%.
Sampling Control: Equipped with a precision syringe sampling device, it achieves a fast sampling speed of 60ml/min while maintaining a sampling volume accuracy of ±1.5%, effectively preventing pipeline clogging.
High Repeatability: Under conditions of >1000 particles/ml and a 5ml sample volume, the test repeatability RSD is
In cleanroom validation and HEPA filter leakage detection, the measurement accuracy of aerosol photometers directly dictates the compliance of test results. However, when performing routine calibration and maintenance, third-party testing laboratories frequently encounter a core technical pain point: sampling flow rate instability and zero drift under ultra-low concentration conditions. To address this industry challenge, the APM-18 Aerosol Photometer Calibrator provides a highly reliable solution grounded in parametric control.
Breaking the Bottleneck of Low-Concentration Calibration Stability
Calibrating the mass concentration indication error of an aerosol photometer at extremely low concentrations requires an exceptionally stable aerosol generation source. Conventional calibrators often suffer from significant concentration fluctuations when outputting trace amounts of aerosols.
The APM-18 Aerosol Photometer Calibrator utilizes a built-in cold Laskin nozzle dust generating system to stably produce multi-scale oil mist particles in the micron range, primarily 0.3µm in size. Regarding core stability metrics, this equipment demonstrates outstanding parameter control:
Ultra-Low Concentration Continuity: Within the ultra-low range of (0.01~1) µg/L, the device achieves a 4-hour stability of ≤5%.
Standard Concentration Precision: In the (1~100) µg/L range, its 20-minute stability is strictly controlled at ≤3%. This output consistency, backed by definitive parameters, effectively resolves the zero drift issue during low-concentration photometer calibration, ensuring the baseline reliability of cleanroom validation instrumentation.
Wide-Range Adjustment and Simultaneous Multi-Device Calibration
Beyond resolving stability issues, third-party testing agencies are equally focused on calibration efficiency. The APM-18 supports a broad concentration adjustment range from 0.01 µg/L to 200 µg/L, which stabilizes in a short period of time.
To enhance laboratory operational efficiency, the calibration system supports 3 photometers for simultaneous sampling. Furthermore, the device supports two types of concentration calibration: the comparison method and the weighing method. The weighing method can be utilized with an optional 1CFM (28.3L/min) precision flow meter and filter membrane sampling device, meeting various high-precision metrological standards.
Eco-Friendly Design with Zero-Discharge Compliance
During high-concentration aerosol generation tests, secondary pollution within the laboratory remains a persistent environmental management concern. The APM-18 incorporates dual-stage filtration and features a user-replaceable liquid-tank sealed HEPA filter with a filtration efficiency of ≥99.99%. This design delivers eco-certified clean air emission, achieving strict zero-discharge compliance and safeguarding both laboratory personnel and the clean environment.
Description: Are you getting false positives in your cleanroom? A Zero-Count Test is essential for accurate particle monitoring. Learn the step-by-step procedure and troubleshooting tips here.
In the field of cleanroom monitoring, data accuracy is everything. A single false count can lead to failed certifications, stopped production lines, or costly investigations. But how do you know if the particles shown on your screen are real contaminants or just "electronic noise"?
The answer lies in the Zero-Count Test.
This fundamental verification step is required by standards like ISO 21501-4 and JIS B 9921. It ensures that your airborne particle counter is not counting particles when the air is perfectly clean.
Here is a professional guide on how to perform this test correctly to ensure your data integrity.
What You Need
Your Airborne Particle Counter (Handheld or Portable).
A Zero Count Filter (usually rated at 0.2µm or better).
A short, clean sampling tube (if applicable).
Step-by-Step Procedure
1. Inspect the Setup Before starting, ensure the inlet of your particle counter is clean. Check the Zero Filter to make sure it is not clogged or damaged. If you are using tubing to connect the filter, ensure the tube is free of kinks and cracks.
2. Connect the Zero Filter Attach the Zero Filter directly to the inlet nozzle of the particle counter. Ensure the connection is tight. Any leakage at the connection point will introduce ambient air, causing the test to fail.
3. Purge the Sensor Do not start recording data immediately. When you first attach the filter, there is still "dirty" air trapped inside the sensor and the tubing.
Run the instrument for 1 to 2 minutes (or take a few sample cycles) without recording data.
This "purge" process flushes out residual particles from the optical chamber.
4. Run the Official Test Configure your instrument to run a standard test cycle.
Duration: According to ISO 21501-4, the recommended testing time is often 5 minutes (or enough time to sample a specific volume of air).
Observation: During this time, watch the display.
5. Analyze the Results What is the pass criteria?
Ideally, the result should be 0 counts.
However, most standards allow for a very small margin of error due to electronic noise (e.g., < 1 count per 5 minutes).
If the count is consistently zero, your instrument’s optical sensor is clean, and the electronics are stable.
What if the Test Fails? (Troubleshooting)
If your counter shows particles while the Zero Filter is attached, don’t panic. Check the following:
Loose Connection: This is the #1 cause of failure. Tighten the filter.
Dirty Filter: Zero filters have a lifespan. If it has been used for years, it might be time to replace it.
Sensor Contamination: If the instrument was recently used in a very dirty environment, the optical lens might need professional cleaning.
Electronic Interference: Ensure the device is not placed near high-voltage machinery or strong electromagnetic fields.
Performing a Zero-Count Test before crucial certification tasks (like HEPA filter leak testing or room classification) is a best practice for any QA professional. It takes only a few minutes but provides the confidence that your data is real and reliable.
Owning a high-precision particle counter is the first step in quality control, but ensuring it consistently produces accurate, consistent, and traceable data throughout its years of service depends on an indispensable safeguard: professional periodic calibration and maintenance. Like any precision instrument, a particle counter's performance can drift over time. The laser's intensity may slowly degrade, dust can accumulate on optical surfaces, and the sample pump's flow rate can subtly change—all of which directly impact measurement accuracy.
An annual calibration performed in accordance with the international standard ISO 21501-4 is a rigorous scientific process. It is far more than a simple comparison; it involves an "as-found" test of the instrument's initial state, a thorough cleaning of the optical and pneumatic systems, a precise calibration of particle sizing and counting efficiency using standard particles traceable to a National Metrology Institute (like NIST or NIM), and a correction of the sampling flow rate. Upon completion, you receive a detailed calibration certificate, which is the authoritative document needed to prove to auditors and regulatory bodies that your measurement equipment is in a state of control. The global calibration services offered by Suzhou Sujing are designed to help clients protect their equipment investment, mitigate compliance risks and production losses caused by inaccurate data, and serve as the critical link in maximizing the full lifecycle value of their instrument.