Recently, a medicine machine said that a customer reported its purchase of purified water equipment red rust phenomenon, worried about the impact of product quality."The red embroidery can't be seen in the water, but it has already affected the quality of the product."In this regard, some people in the industry suggest that regular observation can be made to plan, which is also a way of risk control.
It is understood that the red rust phenomenon is a common phenomenon in the pharmaceutical purification water equipment system, in the system of the pump chamber wall, diaphragm body, tank wall, spray ball and stainless steel welding hot parts often appear.
Experts point out that in the pharmaceutical industry, such as biological products, monoclonal antibodies, blood products, purified water equipment if there is contamination (such as red rust, biofilm or other impurities), it is easy to affect the quality of products.Under the background of strict GMP requirements, the quality department of pharmaceutical enterprises needs to raise the awareness of risk control and make routine maintenance plan.
Red rust is easy to produce, difficult to eliminate, and needs to spend a high cost.Therefore, it is very important to prevent red rust in purified water equipment.So, how should prevent red embroider to produce?
Related technical personnel introduced, the main prevention methods include: control the PH value of purified water, because the distilled water machine raw water is purified water, control its PH value will affect the production of red embroidery on the inlet side;The use of distilled water machine timely remove CO2, increase the conductivity, etc., in addition, users also need to regularly check, regular maintenance of purified water equipment.
In addition to the above measures, the purified water equipment system design, manufacturing materials, pipeline welding and other aspects of the production of red embroidery is also important.The author has learned that in order to comply with the GMP certification requirements of pharmaceutical enterprises, domestic purified water equipment is constantly working on these aspects and optimizing the design.
For example, in the design of the system, there are purified water equipment enterprises in strict compliance with the requirements of the new GMP certification, the overall sanitary grade all with stainless steel design, at the same time, the use of double-stage reverse osmosis purified water treatment technology, effectively remove all kinds of salt in the water, impurities, and strictly control the system of dead corner standards, to prevent crystal corrosion caused by residues.
In terms of manufacturing materials, purified water equipment enterprises select quality assurance materials, material reports of all stainless steel pipe fittings can be traced back to the source, so that the quality of materials and polishing degree are guaranteed.
In the pipeline welding, there are enterprises strict requirements of professional welders in accordance with the welding standard operating procedures for welding."We in the welding section, the whole system are all made of one side welding both sides of the molding process, and purified water contact part adopts imported welding machine automatic welding, after welding need passivation treatment, provide the gauge glasses photos, and provide the pipe spools mapping, welding coding records, pickling passivation, test reports, endoscope inspection pictures, guarantee the welding and passivation effect."Also enterprise personnel so expressed.
In addition, in order to make pharmaceutical enterprises more familiar with the purification water equipment system and process technology, and to be able to operate and maintain independently, some enterprises can also provide users with free training opportunities, so that the technical operators of pharmaceutical enterprises can better understand the relevant operation and maintenance knowledge.
The technicians from the purified water equipment manufacturer suggest that users should pay special attention to periodic maintenance and passivation of the pharmaceutical purified water equipment system. "if the passivation film is found to be corroded, a new passivation film should be generated in time, and the passivation period is recommended to be 1-5 years/time.