Recently, a pharmaceutical robot was asked whether the stainless steel pharmaceutical equipment used in the clean room can use 304 stainless steel? Is it necessary to use 316L for the parts that come into contact with drugs?
In response to this question, industry professionals gave a variety of answers, which can be summarized as one point: 316L equipment is generally used, but there is no mandatory requirement, so 316L is not necessarily required, and the choice is mainly based on product characteristics.
"The purpose determines the material. If it is a simple liquid preparation, the material can be tolerated. But if it is a direct reaction, 304 may not work. Secondly, you need to see the product quality standards, and what are the requirements for multiple metals." This is what the industry said.
So, what is the difference between 316L and 304? According to the data, from the reference point of view, 304 is a common material in stainless steel with a density of 7.93 g/cm³, and 316L is a stainless steel material grade. For example, AISI 316L corresponds to the US label, and sus 316L corresponds to Japan. Label, our country'sunified digital code is S31603; from the content point of view, 304 maintains the inherent corrosion resistance of stainless steel, steel must contain more than 18% chromium and more than 8% nickel; 316L belongs to 18-8 type austenitic Derived steel grade of bulk stainless steel, with 2% to 3% Mo element added; In addition, from the point of view of application, 304 has good processability and weldability, and is used in building materials, chemistry, food industry, agriculture and other fields. , And the corrosion resistance of 316L is stronger than that of 304, and it is more resistant to corrosion in high temperature environments. Therefore, in high temperature environments, engineers generally choose 316L material components.
According to the <<drug production quality management regulations>> (revised edition in 2010), the document does not mandate that the parts of the drug production equipment in contact with the materials must be stainless steel 316L or 304, but it is only required that the production equipment should minimize cross-contamination and direct contact with drugs. It should have corrosion resistance and other conditions.
Among them, “Article 71” emphasizes that “the design, selection, installation, modification and maintenance of equipment must conform to the intended use, and the risks of pollution, cross-contamination, confusion and errors should be reduced as much as possible, and it should be easy to operate, clean, maintain, and maintain. Clean or sterilize when necessary."
In addition, Article 73 mentions that “production equipment must not have any adverse effects on the quality of drugs. The surface of production equipment directly in contact with drugs should be flat, smooth, easy to clean or disinfect, and corrosion-resistant, and must not chemically react or adsorb with drugs. Drugs or release substances into drugs."
In addition to this specification, some people in the industry also mentioned that regarding the stainless-steel material, the ISPE Baseline Guide solid preparation has this description: Generally, the stainless steel that directly contacts the material is 316L or above. Stainless steel that does not directly contact the material should be 306 or above.
In summary, the above-mentioned planning and ISPE do not have mandatory requirements for stainless steel materials. As far as pharmaceutical equipment companies are concerned, it mainly depends on the actual production conditions of pharmaceutical companies.
Pharmaceuticals are special products related to the health and safety of the human body. According to the industry, in order to ensure the quality and safety of medicines, it is better for qualified equipment manufacturers to follow high standards, high requirements, and select good materials to manufacture. However, if there are real difficulties, companies should also consider all possibilities when lowering their design standards. The risk, such as rust, etc., otherwise it may cause more than the gain. In the context of the continuous improvement of pharmaceutical industry standards and increasingly stringent supervision, pharmaceutical companies must strictly implement relevant regulations. As the upstream pharmaceutical equipment industry, they should also do their best to strictly control the quality of equipment to help the development of the pharmaceutical industry.