The maintenance of IVD liquid preparation system is a key link to ensure the quality of diagnostic reagents and the accuracy of test results, involving management in multiple aspects such as cleaning, calibration, and environmental control. The following are specific maintenance methods:
1、 Daily cleaning and pollution prevention
1. Cleaning liquid pipelines and containers: After daily use, thoroughly rinse the system pipelines and containers with deionized water to avoid cross contamination caused by residual reagents; Perform weekly deep cleaning by soaking in 5% dilute nitric acid (for inorganic residues) or ethanol (for organic residues) for 15 minutes, and then rinse with pure water. For example, the cleaning solution needs to meet impurity limit standards, such as avoiding excessive fluorescent whitening agents or heavy metals, to ensure compatibility with the equipment.
2. Appearance cleaning: Gently wipe the equipment casing with warm water and a soft cloth. Do not use highly corrosive solvents such as ethanol and ether to prevent damage to electronic components or mirrors.
2、 Pipeline and connection maintenance
1. Check for blockages and sealing: Regularly inspect the pipeline for blockages or crystallization, use fine needles to clear or replace aging pipelines; Check the elasticity of seals (such as O-rings) and replace them immediately if there is leakage or deformation.
2. Anti corrosion treatment: For acidic and alkaline reagents, the interior of the system should be wiped dry in a timely manner after cleaning to avoid liquid residue corroding components.
3、 Calibration and Performance Verification
1. Regular calibration: Verify the accuracy of liquid preparation monthly using standard solutions (such as pure water weighing method) to ensure that flow and volume errors are less than 1%.
2. System testing: Run blank reagents or standard samples to compare theoretical values. If the deviation is too large, adjust parameters or check sensors.
4、 Environment and operating standards
1. Environmental control: The equipment should be placed in an environment with a temperature below 30 ℃ and moderate humidity, away from electromagnetic interference sources (such as centrifuges), and electronic components should be regularly moisture-proof.
2. Operating habits: Empty the waste liquid bottle before shutting down to avoid corrosion; When idle for a long time, turn on the device 1-2 times a week for half an hour each time to prevent device aging.
5、 Consumables management and recording
1. Consumables replacement: Key consumables such as electrodes and sealing rings have a lifespan of about 1-2 years and need to be updated when response time is delayed or elasticity decreases.
2. Maintenance log: Record cleaning dates, calibration results, and abnormal phenomena (such as data fluctuations) for easy fault tracing.
Regular maintenance can extend the lifespan of equipment and comply with GMP standards. It is recommended to perform basic inspections weekly and comprehensive maintenance once a month.