Distilled water machine and pure steam generator are used in the preparation process of water for injection and pure steam, and equipment and pipe fittings such as sanitary water pump, cooler, heater and diaphragm valve are used in water for injection and pure steam pipeline system. The water for injection and pure steam system verification test test items should be verified and tested item by item based on the principles of system water quality control, microbial control, maintenance and other process control. The verification test items of the water for injection and pure steam system are described as follows.
Verification of distilled water machin The verification of multi-effect distilled water machine is divided into equipment confirmation and water quality verification. The main content of equipment confirmation is inspection, whether the first effect still of the multi-effect distilled water machine as a shell and tube heat exchanger can be Double-end plate structure that strictly eliminates possible cross-contamination in the event of leakage of cooling water and distilled water. Otherwise, the sealing performance, high temperature aging resistance, and how to avoid the risk of leakage and cross-contamination due to the aging of the gasket must be strictly examined as the isolation gasket material for cooling water and distilled water.
For the verification test of the effluent quality of the multi-effect distilled water machine, the heavy metals and other items other than the test items specified in the Pharmacopoeia should be added. In addition, according to the rated water output index of the distilled water machine, the water quality of different water inlet and different boiler steam pressure should be verified respectively. The specific operation is to divide the water inflow below the minimum water inflow, the water inflow above the maximum water inflow, and the rated water inflow and the rated boiler steam pressure range into several sections. The changes in water quality in different sections, especially the changes in the magnitude of bacterial endotoxins, can finally determine the internal control water intake under different boiler steam pressures to ensure that the water quality indicators are controlled from the source of the water for injection.