Daily monitoring of pharmaceutical purified water system

Author: Hongjie Water

After the performance confirmation of the pharmaceutical purified water system is completed, it is usually necessary to develop operational control standards and daily monitoring plans for the water system. According to the requirements of the daily sampling and testing plan, a complete water point sampling plan needs to be recorded in the SOP. QC personnel carry out periodic tests according to the plan, including pH value, bacteria number, conductivity, Total organic carbon, microorganisms and chemical indicators, which are all test items. The obtained data can provide a basis for subsequent maintenance personnel to identify adverse trends in system operation and avoid using unqualified purified water for production.

The operation and maintenance personnel enter the site to conduct daily operation records, equipment inspections, and monitor the normal operation status of the purified water equipment. The parameters that need to be recorded include inlet pressure/temperature, RO inlet and outlet water flow rate/pressure, pH value, EDI outlet conductivity/flow rate, tank level/temperature, return water flow rate/flow rate/conductivity, and TOC. At the same time, these key data must be transmitted to the factory monitoring system to ensure real-time monitoring and alarm, effectively helping operation and maintenance personnel better maintain the water system.

In the pharmaceutical purified water equipment system, the common alarm information that needs to be recorded in the purified water preparation system is mainly the EDI produced water conductivity high alarm. The alarm information related to the distribution system mainly includes low return water flow alarm, high return water conductivity alarm, low liquid level alarm, and online TOC high alarm. Alert and correction limits are set for alarms, among which the alert limit refers to the alarm, but no special correction measures need to be taken, but operation and maintenance personnel should conduct investigations; The correction limit is because the system deviates from the normal limit, and corresponding correction measures should be taken to return the system to its normal operating state.

In order to eliminate the factors that lead to equipment failure and unplanned production interruption, the pharmaceutical purified water system will carry out corresponding preventive maintenance, and the maintenance cycle, maintenance methods, maintenance records and maintenance results of the system will be specified in SOP. Common maintenance items for pharmaceutical water systems include but are not limited to replacement and integrity testing of respirator filter elements, inspection and replacement of valve gasket membranes, daily disinfection of the system such as pasteurization, cleaning and passivation of the system, addition and replacement of pre-treatment fillers, replacement of security filter elements, replacement of reverse osmosis membranes/EDI devices, cleaning of drain Y-filters, wiring inspection of electrical cabinets, inspection of motor insulation performance, inspection and inspection of instruments and meters Aging inspection and replacement of compressed air hoses, inspection and repair of leaks and leaks in clamps and valves, etc.

The management personnel of the pharmaceutical purified water equipment system shall conduct a quality review at least once a year to understand the trend of changes in the water system over time. They can adjust the warning and correction limits set by the system based on data analysis, and revise the operating instructions. In addition, the systematic quality review includes not only the water quality sampling results, but also the drawing review, verification status, preventive maintenance and troubleshooting records, key deviations and alarms, daily monitoring results and trends, etc.