Do you know the material requirements for stainless steel pharmaceutical equipment in the clean area?

[Pharmaceutical Network Technical Article] Recently, a pharmaceutical robot asked whether the stainless steel pharmaceutical equipment used in the clean workshop can use 304 stainless steel? Do the parts in contact with medicines have to be made of 316L material? In response to this question, industry professionals have given a variety of answers, which can be summarized into one point: generally, 316L equipment is used, but there is no mandatory requirement, so 316L is not necessarily required, and the choice is mainly based on product characteristics
.

"The use determines the material
.

If it is a simple solution, the material can be tolerated
.

But if it is a direct contact with the reaction, 304 may not work
.

Secondly, it also depends on the quality standard of the product, and what requirements are there such as heavy metals
.

" The industry said so
.

So, what is the difference between 316L and 304? According to the data, 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 American designation, and sus 316L corresponds to the Japanese designation.
Label, China's unified digital code is S31603; from the content point of view, 304 maintains the inherent corrosion resistance of stainless steel, the steel must contain more than 18% chromium and more than 8% nickel content; 316L belongs to 18-8 type austenitic It is a derivative of stainless steel with 2% to 3% Mo element added.
In addition, from the application point of view, 304 has good processability and weldability, and has been used in building materials, chemistry, food industry, agriculture and other fields.
, while the corrosion resistance of 316L will be stronger than that of 304, and it is more resistant to corrosion in high temperature environments
.

Therefore, in high temperature environments, engineers generally choose parts made of 316L material
.

 　　According to the Good Manufacturing Practice for Drugs (2010 Revised Edition), there is no mandatory use of stainless steel 316L or 304 for the parts of drug production equipment in contact with materials in the document, but it is only required that production equipment should minimize cross-contamination and equipment that is in direct contact with drugs It should have conditions such as corrosion resistance
.

 　　Article 71 of them emphasizes that "the design, selection, installation, modification and maintenance of equipment must be in accordance with the intended purpose, and should minimize the risk of contamination, cross-contamination, confusion and errors, and facilitate operation, cleaning, maintenance, and Cleaning or sterilization when necessary
.

” In addition, Article 73 mentions, “The production equipment shall not have any adverse effect on the quality of the drug
.

The surface of the production equipment in direct contact with the drug shall be flat, smooth, easy to clean or disinfect, and resistant to corrosion.
, shall not react chemically with drugs, adsorb drugs or release substances into drugs
.

” In addition to this specification, some industry insiders also mentioned that regarding stainless steel materials, the ISPE Baseline Guide solid preparations have such a description: stainless steel that generally directly contacts materials Use 316L or above
.

Stainless steel that does not directly contact the material is made of 306 or above
.

 　　In summary, the above-mentioned plans and ISPE have no 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
.

 　　Medicines are special commodities, which are related to human health and safety
.

The industry said that in order to ensure the quality and safety of drugs, it is natural for qualified equipment manufacturers to manufacture according to high standards, high requirements, and select materials.
risk, such as rust, etc.
, otherwise it may cause more harm than good results
.

In the context of the continuous improvement of pharmaceutical industry standards and the increasingly stringent supervision, pharmaceutical companies must strictly implement relevant regulations.
As an upstream pharmaceutical equipment industry, they should also do their best to strictly control the quality of equipment and help the development of the pharmaceutical industry
.

 Pharmaceutical equipment (Image source: Pharmaceutical Network)