Requirements Does the Pharmaceutical Industry Have for Purified Water Equipment?

Higher Water Quality

Strict Microbial Indicators: Purified water for pharmaceutical use needs to strictly control the microbial limit, usually requiring that the total number of bacteria, mold and yeast per milliliter of water does not exceed a certain number. For example, the Chinese Pharmacopoeia stipulates that the microbial limit standard for purified water is not more than 100CFU per 100ml.

 Control of Endotoxin: Endotoxin is a component in the cell wall of Gram-negative bacteria, which can cause fever reactions in drug users and is harmful to human health. In the pharmaceutical industry, especially in the production of sterile drugs such as injections, there are strict restrictions on the endotoxin content in purified water, generally requiring that the endotoxin content per milliliter of purified water does not exceed 0.25EU.

Removal of Ion Impurities: During the pharmaceutical process, certain ion impurities may react with drug components and affect drug quality. Therefore, purified water equipment needs to have the ability to efficiently remove various ions, so that the resistivity of purified water meets certain requirements, usually not less than 0.5MΩ・cm at 25℃.

Materials Meet Sanitary Standards

Materials in Contact with Water: Parts of the purified water equipment in contact with purified water, such as pipelines, storage tanks and valves, should be made of materials that meet the sanitary standards of the pharmaceutical industry, such as 316L stainless steel. This material has good corrosion resistance and sanitary performance, and can avoid the dissolution of substances in the material to pollute purified water.

Surface Treatment Requirements: The inner surface of the equipment needs to be polished with high precision to reduce the possibility of bacterial growth and impurity adhesion. For example, the roughness of the inner surface of the pipeline is usually required to reach Ra≤0.8μm to ensure the smooth flow of water in the pipeline and prevent the formation of biofilm.

Strict Validation and Confirmation

Installation Qualification (IQ): After the equipment is installed, a comprehensive inspection and confirmation of the equipment installation status is required, including whether the installation position, pipeline connection and electrical connection of the equipment meet the design requirements, and whether the technical data of the equipment is complete.

 Operational Qualification (OQ): After the installation qualification is passed, conduct operational qualification. Through no-load and load operation tests of the equipment, verify whether the equipment can operate stably under different operating conditions and whether various parameters meet the set requirements, such as pressure, flow rate, temperature and resistivity.

 Performance Qualification (PQ): Performance qualification is carried out after the operational qualification is passed. By continuously producing multiple batches of purified water and conducting comprehensive detection and analysis of its water quality, it is confirmed whether the equipment can continuously and stably produce purified water that meets the quality standards. It is usually required to conduct verification for at least three consecutive batches, and the water quality of each batch should meet the specified quality standards.

Improved Monitoring and Management System

Online Monitoring: Purified water equipment in the pharmaceutical industry usually needs to be equipped with a complete online monitoring system to monitor key water quality parameters of purified water in real time, such as resistivity, conductivity, microbial content and endotoxin. Once the water quality parameters exceed the set range, the system can immediately issue an alarm so that operators can take timely measures.

Data Recording and Traceability: The equipment should have data recording and storage functions, and can automatically record the operating parameters of the equipment, water quality monitoring data and other information. These data should be traceable for query and analysis when needed, providing a basis for quality control and traceability of drug production. The data retention period should usually meet the requirements of Good Manufacturing Practice (GMP), generally not less than the validity period of the drug plus a certain period of time.

Equipped with Cleaning and Disinfection Functions

Automatic Cleaning System: Purified water equipment needs to be equipped with an automatic cleaning system to regularly clean the equipment to remove dirt, microorganisms and other impurities on the inner surface of the equipment. The cleaning process usually includes water washing, alkali washing, acid washing and other steps, which can be automatically carried out according to the set program to ensure the consistency of cleaning effect.

Disinfection Methods: To effectively kill microorganisms in water and remove endotoxins, purified water equipment in the pharmaceutical industry often adopts disinfection methods such as pasteurization, ultraviolet disinfection and ozone disinfection. These disinfection methods should be able to comprehensively and effectively disinfect the equipment and pipelines without affecting the quality of purified water. For example, pasteurization kills microorganisms by heating purified water to a certain temperature (such as about 80℃) and maintaining it for a period of time