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[ Focus on Chemical Machinery and Equipment Network ] Medicines are special commodities and are related to human health.
Therefore, it is very important to ensure the quality and safety of medicines.
In any process of pharmaceutical production, it is necessary to strictly follow the standards and regulations.
As the "mother machine" of the pharmaceutical industry, pharmaceutical equipment also needs to meet strict requirements, and strengthen controls on material selection, design, model selection, and installation.
Chemical machinery and equipment network hotspots pay attention to chemical machinery and equipmentTherefore, it is very important to ensure the quality and safety of medicines.
In any process of pharmaceutical production, it is necessary to strictly follow the standards and regulations.
As the "mother machine" of the pharmaceutical industry, pharmaceutical equipment also needs to meet strict requirements, and strengthen controls on material selection, design, model selection, and installation.
In my country's "Pharmaceutical Manufacturing Quality Management Regulations (Revised in 2010)", it is specifically mentioned in terms of equipment: "The design, selection, installation, transformation and maintenance of equipment must meet the intended use, and pollution and cross-contamination should be reduced as much as possible , The risk of confusion and errors, to facilitate operation, cleaning, maintenance, and disinfection or sterilization when necessary".
In addition, the document also mentions that “the production equipment must not have any adverse effects on the quality of the drugs.
The surface of the production equipment directly in contact with the drugs should be flat, smooth, easy to clean or disinfect, corrosion-resistant, and must not chemically react with the drugs or absorb the drugs Or release substances into drugs" etc.
The surface of the production equipment directly in contact with the drugs should be flat, smooth, easy to clean or disinfect, corrosion-resistant, and must not chemically react with the drugs or absorb the drugs Or release substances into drugs" etc.
The upstream of pharmaceutical equipment is raw materials, accessories and other industries.
In the whole process of designing, manufacturing and application of pharmaceutical equipment, the selection of raw materials is very important.
In the whole process of designing, manufacturing and application of pharmaceutical equipment, the selection of raw materials is very important.
The industry pointed out that due to the uniqueness of pharmaceutical equipment, the materials selected should be non-toxic, anti-corrosive, easy to clean or sterilize, do not chemically change with drugs, and do not absorb or release chemical substances.
However, due to the lack of standards for the selection of materials in the industry, in the specific manufacturing process, pharmaceutical companies, scientific research institutions, or manufacturers of pharmaceutical machinery have an impact on the properties of materials (including chemical properties, mechanical equipment properties, structural mechanical properties, etc.
), as well as GMP and pharmaceutical The process does not have a deep understanding of the requirements for the selection of equipment and materials, and it is often easy to enter a misunderstanding when selecting materials, and the equipment produced does not meet the real requirements, which seriously affects the quality of drug production.
), as well as GMP and pharmaceutical The process does not have a deep understanding of the requirements for the selection of equipment and materials, and it is often easy to enter a misunderstanding when selecting materials, and the equipment produced does not meet the real requirements, which seriously affects the quality of drug production.
Take austenitic stainless steel as an example.
This type of stainless steel is a very widely used material for pharmaceutical equipment.
Common varieties include 316L, 316, 304L, etc.
The common feature is good corrosion resistance, but "corrosion resistance" is actually relative.
Refers to high chemical stability in certain external conditions and certain corrosive media.
Therefore, when used under certain media conditions, this type of material may produce intergranular corrosion, pitting corrosion and other types of corrosion, which cannot meet the requirements of pharmaceutical production.
This type of stainless steel is a very widely used material for pharmaceutical equipment.
Common varieties include 316L, 316, 304L, etc.
The common feature is good corrosion resistance, but "corrosion resistance" is actually relative.
Refers to high chemical stability in certain external conditions and certain corrosive media.
Therefore, when used under certain media conditions, this type of material may produce intergranular corrosion, pitting corrosion and other types of corrosion, which cannot meet the requirements of pharmaceutical production.
So, how to prevent corrosion of austenitic stainless steel? Related measures can include: reducing the carbon content in stainless steel, using low-carbon stainless steel or ultra-low stainless steel, etc.
; solid solution treatment to eliminate the tendency of intergranular corrosion; when welding materials, try to choose automatic welding; structural design, reducing welding Seams or staggered arrangements of welds.
For materials used at high temperatures, try to reduce thermal expansion structure and reduce corrosion tendency.
; solid solution treatment to eliminate the tendency of intergranular corrosion; when welding materials, try to choose automatic welding; structural design, reducing welding Seams or staggered arrangements of welds.
For materials used at high temperatures, try to reduce thermal expansion structure and reduce corrosion tendency.
In addition to the selection of anti-corrosion materials, another important material selection principle is often overlooked, that is, the effective control of insoluble particles.
In medicines, the presence of particles will directly affect the quality of medicines.
Take the pulverizer as an example.
When some high-speed running parts are in direct contact with the material and wear, it is often accompanied by a small amount of metal particles or insoluble impurities.
If the index requirements are not up to standard, it means that the product lacks reliability.
grinder In medicines, the presence of particles will directly affect the quality of medicines.
Take the pulverizer as an example.
When some high-speed running parts are in direct contact with the material and wear, it is often accompanied by a small amount of metal particles or insoluble impurities.
If the index requirements are not up to standard, it means that the product lacks reliability.
The industry pointed out that the source of insoluble particles generally has multiple aspects in the production process, including equipment or appliance systems.
The key to the control of insoluble particles in equipment or appliance systems is closely related to the material.
Therefore, in order to ensure the number of insoluble particles, it is necessary to strictly control the selection of materials.
The key to the control of insoluble particles in equipment or appliance systems is closely related to the material.
Therefore, in order to ensure the number of insoluble particles, it is necessary to strictly control the selection of materials.
Generally speaking, the selection of pharmaceutical equipment needs to be comprehensively selected based on the process and actual application, while also taking into account other factors such as insoluble particles, in order to truly meet the requirements of GMP and escort the quality of pharmaceutical production.
Pharmaceutical equipment Original title: To escort the quality of pharmaceutical production, the selection of the "mother machine" should not be ignored
