What are the precautions for maintenance of pharmaceutical purified water equipment?

Pharmaceutical purified water technology: Building a solid foundation for drug quality and leading the future development of the industry

The maintenance and upkeep of pharmaceutical purified water equipment should focus on water quality, equipment status, and compliance. The following are simplified points:

1、 Daily monitoring and inspection

Water quality: Record conductivity, TOC and other indicators every 2 hours, and immediately shut down for inspection if exceeding the standard.

Equipment:

Pump set: Check for noise, vibration, and bearing temperature (<60 ℃), and regularly replenish lubricating oil (every 3 months).

Membrane module: Monitor the pressure difference between the inlet and outlet (increase by 15% and require cleaning) to avoid long-term shutdown (seal with protective solution for more than 24 hours).

Pipeline/water tank: Check for leaks, wipe the tank to prevent the growth of microorganisms in condensed water.

Instruments/valves: Ensure flexible opening and closing, accurate readings (instruments calibrated annually).

2、 Shutdown management

Short term (<7 days): Low pressure flushing of membrane components (30 minutes per day), keeping the water level in the tank at 70% -80%.

Long term (>7 days): Seal the membrane with protective solution, drain and dry the pipeline, and conduct full water quality testing before restarting.

3、 Personnel and Records

Training: At least 2 operation training sessions per year, unauthorized personnel are prohibited from participating.

Record: Establish a 'Maintenance Ledger', detailing the time, content, accessories, and testing results, and archive it for one year after the equipment is scrapped.

4、 Key preventive measures

Preprocessing optimization: Strengthen filtration and softening to reduce membrane fouling load.

Disinfection effectiveness: Regularly verify UV intensity and ozone concentration (UV ≥ 30W/cm ², ozone ≥ 0.3mg/L).

Spare parts management: Reserve commonly used accessories (such as membrane components and resins) to shorten the time for troubleshooting.

Through daily inspections, periodic maintenance, and standardized records, ensure the stable operation of equipment and continuous compliance with GMP and other regulatory requirements.