Storage and Distribution System

Product Introduction

The purpose is to deliver pharmaceutical water that meets the quality requirements of the pharmacopoeia to various process points at flow rates, pressures, and temperatures that meet production requirements. The storage and distribution system consists of storage units, distribution units, and water point pipeline units. In storage and distribution systems, due to the water in the tank being in a "relatively static" state, the tank becomes a place where microorganisms are more likely to grow. Therefore, in addition to periodic disinfection and sterilization of the storage tank, the polishing degree of the inner wall of the tank should be ≤ 0.6 μ m to ensure surface smoothness and prevent microorganisms from adhering to the tank wall and forming difficult to remove biofilms.

Storage unit

1. The storage unit is used to store pharmaceutical water that meets pharmacopoeia requirements and meets the system's high peak usage requirements. The storage system must maintain the quality of water supply in order to ensure the qualified quality of product end use.

2. From a bacterial perspective, a smaller storage tank is better because it increases the system's circulation rate and reduces the likelihood of rapid bacterial growth. A smaller preparation system operates closer to a continuous dynamic flow state. Generally speaking, the emptying frequency of the storage system needs to meet 1-5 times/h, and it is recommended to use 2-3 times/h, which is equivalent to a tank turnover time of 20-30 minutes.

tank design

1. When the storage and distribution system adopts pasteurization, the tank body is generally designed at atmospheric pressure. When the storage and distribution system uses pure steam or superheated water sterilization, the storage tank is designed as a pressure vessel.

2. The tank accessories usually include a 360 degree rotating spray ball, a breathing apparatus with a heated jacket, temperature sensors, liquid level sensors, bursting discs, pressure gauges, etc.

3. Spray balls are used for tank cleaning, and their cleaning effect can be verified through riboflavin testing.

4. Respirators are one of the basic requirements explicitly mentioned in all GMP, mainly used to effectively block the impact of external particles and microorganisms on the water quality of the tank. The respirator for purified water storage tanks is checked by regularly replacing the filter element to prevent the growth of microorganisms. During the replacement period, online sterilization can be used to prevent the growth of microorganisms.

Clean pipeline distribution system

1. Each allocation system needs to be customized according to the actual needs of customers.

2. The PW/WFI distribution system mainly consists of the following components: a conveying pump with variable frequency control, a heat exchanger and its heating or cooling device, a sampling valve, a diaphragm valve, and 316L material pipeline fittings; Online detection and control system for temperature, pressure, conductivity, TOC, etc.