In the pharmaceutical industry, water purity directly impacts drug safety and production compliance. With the implementation of the 2025 edition of the Chinese Pharmacopoeia, which includes new requirements such as Burkholderia cepacia complex (BCC) testing and strengthened microbial limit control, SDI (Silt Density Index) testing of pharmaceutical water has become a critical aspect of compliance. A large pharmaceutical company (hereinafter referred to as “Company X”) previously faced challenges such as large errors in manual SDI testing, frequent RO membrane fouling, and difficulties in data traceability during regulatory audits. By introducing a portable automatic SimpleSDI test kit, the company achieved accurate, efficient, and fully compliant water quality testing. The following is a detailed application case.
Water Quality Testing Challenges for Phar
maceutical Companies: Traditional Solutions Struggle to Meet the New Requirements of the 2025 Pharmacopoeia
Company X specializes in injectable drug production, with a water system includes pretreatment, RO/EDI purification, and finished water storage, with an average daily water consumption of 500 tons. Before introducing the Portable Automatic SimpleSDI Test Kit, the company relied on manual SDI testing, and encountered three core problems:
- High compliance risk: The manual testing process relies on human operation, and data recording is prone to omissions, failing to meet the stringent requirements of the 2025 Pharmacopoeia for “traceable and repeatable test data.” The company received several corrective action recommendations during regulatory audits;
- Severe membrane system damage: Traditional methods could not monitor the trend of filter membrane clogging in real time. RO membranes experienced a pressure difference increase of 0.03 MPa per month due to colloidal and particulate contamination, resulting in annual membrane element replacement costs exceeding tens of thousands of yuan;
- Low testing efficiency: A single manual test required two technicians to be on duty for more than 20 minutes, with an error rate as high as ±10%, resulting in high labor costs.
These problems not only affected production continuity but also exposed the company to the potential risk of product recalls, highlighting the urgent need for an intelligent SDI testing device that complies with the new Pharmacopoeia.
Solution: Targeted Deployment of Portable Automatic SimpleSDI Test kit.
Addressing the pain points of Company X and combining the core requirements of the pharmaceutical industry – “compliance first, precision and efficiency, and multi-scenario adaptability” – the SimpleSDI Test kit provides solutions from three dimensions:
1.Full-Process Compliance Design, Directly Addressing the Core Requirements of the 2025 Pharmacopoeia：
The tester strictly adheres to the ASTM D4189-07 (2014 revised edition) standard, using a standard filter membrane with a pore size of 0.45um, φ 47mm, and made of mixed cellulose ester, ensuring that the test results are recognized by national drug regulatory agencies. The built-in storage module can automatically record 100 sets of test data, including key parameters such as SDI value and test time, perfectly meeting GMP data integrity requirements. The entire flow path uses non-ferrous materials and an anti-backflow design to avoid secondary contamination during the sampling process.
2.Automated Testing Breaks Through Manual Limitations and Improves Detection Accuracy
After starting the tester, it can automatically complete six modes of SDI-5/10/15-100ml/500ml testing, generating multi-dimensional data within 15 minutes, without requiring personnel to be present throughout the process. Equipped with a high-precision flow sensor, the test error is ≤±1%, far superior to manual testing accuracy, and can accurately capture subtle pollution changes in low-turbidity water (U), providing accurate data support for RO membrane protection. The large LCD screen displays the SDI value and flow rate changes in real time, helping operators predict membrane fouling trends and develop cleaning plans in advance.
3.Portable Design Adapts to Multiple Scenarios and Lowers Operating Thresholds
The tester weighs only 2.7kg, is equipped with a pressure-resistant and drop-proof engineering plastic carrying case, and the built-in lithium battery can continuously test for 20 hours on a single charge, meeting the sampling needs of multiple scenarios such as the pretreatment section of Company X’s workshop and the RO system influent. It supports 35-100psi wide-pressure water inlet, and the dual pressure regulation design ensures that the pressure remains stable at 30psi during testing. The operation interface is simple and clear, and ordinary operators can complete the test independently after half an hour of training, significantly reducing labor costs.
Application Results: Compliance Upgrade and Cost Optimization Achieved in 3 Months
After deploying two SimpleSDI Test kit at key nodes of its water system (pre-treatment outlet and RO membrane inlet), Company X achieved significant results after 3 months of operation:
- Full Compliance: Test data is traceable throughout the entire process. In the first special audit under the 2025 edition of the Chinese Pharmacopoeia, the company successfully passed the compliance review with complete SDI test records and accurate data analysis, without any required corrective actions;
- 25% Extension of Membrane System Lifespan: By regularly monitoring changes in SDI values, membrane fouling risks were predicted in advance. The RO membrane cleaning cycle was extended from the original 15 days to 25 days, extending the service life of membrane elements by 35%, saving approximately 280,000 RMB in membrane replacement costs annually;
- 50% Improvement in Detection Efficiency: The single test time was reduced from 30 minutes to 20 minutes. Operators only need to perform preparation work; subsequent testing is automatically completed by SimpleSDI Test kit;
- Doubled Emergency Response Speed: When raw water is suddenly contaminated, operators can arrive at the water intake point within 10 minutes with the tester to complete the detection, quickly locating the source of pollution and avoiding production interruptions.
Core Technological Advantages: Why is it the Preferred SDI Testing Solution for Pharmaceutical Companies?
The SimpleSDI Test kit solves Company X’s pain points due to its deeply customized design for the pharmaceutical industry:
- Wide Standard Compatibility: Compatible with mainstream global standards such as the 2025 edition of the Chinese Pharmacopoeia, GMP, and ASTM D4189-07, eliminating the need for frequent changes in testing procedures;
- Industry-Leading Accuracy: The combination of a microprocessor and flow sensor ensures that the test error is far below the industry average, meeting the testing requirements for high-purity pharmaceutical water;
- Low Operating and Maintenance Costs: Consumables are globally available, and the lithium battery has a long service life, eliminating the need for frequent charging or replacement of parts, reducing long-term operating costs;
- High Level of Intelligence: Supports automatic data storage, anomaly alarms, and multi-mode testing, reducing human intervention and improving the reliability of test data. V. Conclusion: Empowering Pharmaceutical Water Quality Compliance with Technology, Safeguarding the Bottom Line of Drug Safety
The implementation of the 2025 edition of the Chinese Pharmacopoeia is driving the pharmaceutical industry into a new stage of “precise quality control and preventive management.” The portable automatic SimpleSDI Test kit, through its compliant design, automated operation, and portable layout, has helped Company X solve the core pain points of water quality testing.
For pharmaceutical companies facing similar compliance pressures, choosing an accurate and efficient SDI testing device that is compatible with the new Pharmacopoeia is crucial for reducing production risks, controlling operating costs, and achieving sustainable development. The SimpleSDI Test kit will continue to focus on technological innovation to provide the pharmaceutical industry with higher-quality water quality testing solutions, helping companies move steadily forward on the path to compliance.