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E-mail
13310668118@163.com
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13310668118
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Qingdao Xinruide Environmental Protection Technology Co., Ltd
Comprehensive Guide to Common Problems and Solutions of GMP Injection Water Equipment
Date: 2025-08-20Read: 3
Common problems and solutions of GMP injection water equipment:
1. Preprocessing system
-Filter blockage: The pressure difference before and after the pre-treatment filter (PP cotton/activated carbon) is greater than 0.1MPa, and the water production flow rate decreases by more than 30%. The solution is to immediately replace the filter element. If the quality of the raw water is poor for a long time, a bag filter (with a precision of 5 μ m) can be installed; Establish a filter replacement ledger, set a pressure difference alarm threshold (0.07MPa), and link the PLC to automatically remind.
-Softening resin failure: The hardness of the softened water outlet is greater than 50ppm, and white scaling appears on the surface of the RO membrane. The solution is to manually trigger the regeneration program, increase the salt dosage to 200g/L, and rinse until the effluent hardness is less than 10ppm; Install an automatic salt adding device and regularly check the water level in the salt tank (maintaining at least 1/3).
2. Reverse osmosis (RO) system
-Desalination rate decreases: the conductivity of RO produced water is greater than 10 μ S/cm (when the raw water is 200 μ S/cm), and the desalination rate of membrane elements is less than 95%. The solution is chemical cleaning. When organic matter is contaminated, use a 2% citric acid solution (pH 3-4) to circulate and clean at 40 ℃ for 2 hours; When microbial contamination occurs, circulate a 0.5% sodium hydroxide+0.3% hydrogen peroxide solution for 1 hour; A residual chlorine sensor can also be installed to automatically close the inlet valve and replace the anti pollution RO membrane (such as Dow BW30-400IG) when it exceeds the standard.
-Membrane module high pressure alarm: If the outlet pressure of the high pressure pump continues to exceed the set value, the equipment will shut down for protection. The solution is to slowly adjust the concentrated water valve to maintain a 1:3 ratio of concentrated water to produced water; Check the status of the water production back pressure valve to ensure that there is no blockage in the water production pipeline (slope ≥ 3 °).
3. Distillation system
-The water produced by the multi effect distilled water machine exceeded the endotoxin limit: Regular testing found that the endotoxin exceeded the limit (>0.25EU/ml), and there were no significant abnormalities in the equipment operating parameters. The solution is chemical passivation, which involves circulating an 8% nitric acid solution to clean the distillation tower for 30 minutes and re form a passivation film; Reduce the cooling water temperature to below 20 ℃ and install plate heat exchangers; Sterilize the distillation system with pure steam (121 ℃, 30 minutes) every week.
-Decreased heating efficiency: During steam heating, the outlet water temperature of the distillation tower cannot reach the design value, and the water production rate decreases. The solution is to check the status of the steam pressure reducing valve and replace it if necessary; Clean the heat exchanger with a 10% citric acid solution for 2 hours until the temperature difference between the inlet and outlet is less than 5 ℃.
4. Disinfection and sterilization system
-The efficiency of the UV sterilizer decreases: the microorganisms in the UV effluent are greater than 10CFU/ml, and the running time of the lamp tube is greater than 8000 hours. The solution is to replace the UV lamp immediately (it is recommended to replace it once a year); Wipe the quartz sleeve with an alcohol swab. If the scaling is severe, soak it in a 5% acetic acid solution for 30 minutes.
-Insufficient gas production of ozone generator: The concentration of ozone water cannot meet the disinfection requirements, abnormal noise occurs during equipment operation, the temperature in the discharge chamber is greater than 40 ℃, and ozone decomposition intensifies. The solution is to install a three-stage air source filter (oil removal+water removal+dust removal) and regularly discharge condensed water; Check the cooling system to ensure that the temperature in the discharge chamber is below 30 ℃, and replace the ozone tube if necessary.
5. Control system
-Abnormal display of conductivity meter: The online conductivity meter reading fluctuates by more than 20%, or continuously displays 18.2M Ω· cm (in ultrapure water state). The solution is to soak the electrode in 10% nitric acid solution for 30 minutes, rinse and calibrate (standard solution 1413 μ S/cm); Check the shielding layer of the 4-20mA signal line and replace the faulty module (the backup module needs to be verified in advance).
-Automatic backwash program failure: The RO system has reached the set backwash cycle (such as every 4 hours of operation) without triggering backwash. The solution is to manually trigger backwashing and check if the solenoid valve operates normally (listen for a clicking sound+observe pressure changes); Replace the time relay and download the PLC program again (keep the original program backup).
6. Emergency fault handling process (taking microbial exceedance as an example)
-Quick response: Immediately stop using water, isolate faulty equipment, take double samples of raw/produced water and send them for third-party testing; Activate backup equipment (such as temporary RO devices) to ensure uninterrupted production.
-Root cause analysis: Use ATP detector to locate the site of microbial growth (such as RO membrane inlet/tank dead corner); Trace the maintenance records of the past three months and investigate whether the filter replacement and disinfection cycles are compliant.
-Rectification measures: Strengthen disinfection of contaminated areas (such as circulating peracetic acid solution for 2 hours); Revise maintenance procedures and increase disinfection frequency from once a week to twice a week.
-Verification and recovery: The water quality should be tested continuously for 3 days, and the microbial count should be ≤ 1CFU/ml and the trend should be stable before restarting the equipment; Submit a deviation report to the drug regulatory department (if it involves drug production).
7. Preventive maintenance strategy
-Regular testing plan: Monitor conductivity, pressure, and flow rate daily, and record deviations; Perform weekly microbiological rapid testing (ATP method) and ultraviolet intensity testing; Conduct a comprehensive water quality analysis (endotoxin, TOC, heavy metals) every month.
-Consumables replacement warning: Replace the RO membrane when the cumulative water production reaches 5000 tons or the desalination rate decreases by 5%; Ion exchange resin resistivity<15MΩRegeneration/replacement at cm.
-Personnel training: Conduct equipment failure simulation drills every quarter (such as emergency response to RO membrane fouling); Operators need to pass the GMP equipment management assessment (certified to work).
