Medical purified water equipment is the primary process system produced by the pharmaceutical industry. The guarantee of water quality standards is one of the important factors for the safety of pharmaceutical production. Therefore, the process configuration of purified water equipment should be properly planned.
Medical purified water equipment planning requirements
1. Structural planning should be simple, reliable, and easy to disassemble.
2. In order to facilitate disassembly, replacement, and cleaning of components, the planning of the implementing agency shall use standardized, generalized and systematic components as much as possible.
3. The exterior and exterior walls of the equipment require smooth lubrication, no dead corners, and easy cleaning and sterilization. Parts should be treated with chrome plating to prevent corrosion and prevent rust. Prevent paint from falling on the outside of the device to prevent it from falling.
4. Medical purified water equipment should use low-carbon stainless steel or other materials that have been verified not to pollute the water quality. The purified water equipment should be cleaned regularly and the cleaning effect verified.
5. The information for contact with water for injection must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other materials that have been verified not to cause water pollution. Equipment for preparing water for injection should be cleaned regularly, and the cleaning effect should be verified.
6. The storage period of purified water should not be longer than 24 hours, and its storage tank should be made of stainless steel materials or other materials that have been verified to be non-toxic, corrosion-resistant, and not to leak pollution ions. A hydrophobic sterilizing filter should be installed to protect the ventilation openings so as not to drop fibers. The inner wall of the tank should be lubricated, and the joints and welds should not have dead ends and trachoma. Sensors that display parameters such as liquid level, temperature, and pressure that do not form water pollution should be selected. The storage tank shall be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effects shall be verified.
Knowing the above-mentioned technical planning standards for medical purified water equipment, and reasonable planning for production and use of medical purified water equipment, can fully ensure that the water quality is safely transported to the water point for drug production, and that drug production is not affected by water quality problems.
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