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[Pharmaceutical Network Enterprise News] Today, the State Administration for Market Regulation issued the "Announcement of the State Administration for Market Regulation on Food Safety Supervision and Sampling Inspection by Market Supervision Authorities in 2021": The pass rate of dairy products sampling inspection is 987% The pass rate of infant formula milk powder sampling inspection is 987% 988% 100% pass rate of sampling inspection of formula food for special medical purpose (Food for Special Medical Purpose, FSMP) Formula food for special medical purpose is to meet the requirements of eating restriction, digestion and absorption disorder, metabolic disorder or specific disease The special needs of nutrients or diets of the state population are specially processed and prepared formula foo.
Food for Special Medical Purposes · New Track From 2016 to now, a total of 83 types of special medical food in China have been registered, including 46 types of formula food for special medical purposes and 37 types of special medical food for infan.
Feihe, Nestle, Abbott, Danone, Mead Johnson, Beingmate, and Shengyuan have all deployed special medical fo.
Food for Special Medical Purposes High Requirements Special medical food is a kind of food with extremely high requirements for food safety and strong regulatio.
Although the current volume is small, the production management of special medical food requires that the production units are linked togeth.
Everythi.
Food for Special Medical Purposes · Good prospects China is a country with a large population and an aging populati.
With the development of clinical nutrition, the demand for such food by clinicians and patients is increasing, and the future development potential of special medical food is also very gre.
The special medical food industry is expected to usher in further breakthroughs under market norms and become the third largest health "blue ocean" in China's general health field after drugs and equipme.
Judging from the number of approved products for FSMP registration, the number of domestic companies and foreign companies is comparable, with domestic products accounting for 59% of the tot.
Pharmaceutical companies and dairy companies are currently the main force in the industry, especially dairy companies have expressed their interest in FS.
of great enthusia.
The special medical food industry not only pays attention to the research and development capabilities of enterprises, but also tests the comprehensive capabilities of enterprises in various aspects such as production and quality contr.
Special medical food not only needs to meet the needs of people with special nutritional needs under pathological conditions, such as patients with diabetes, kidney disease, and other diseases or surgical rehabilitation personnel, but also includes people with special nutritional needs under non-pathological conditions, such as pregnant women, infants and young children , the elderly,e.
Therefore, different types of special medical food have the same strict requirements in terms of quality and safe.
In view of the strict requirements for the quality of special medical products, it is necessary to have high-standard and high-quality performance in all aspects of producti.
Therefore, the state has promulgated the GB29923-2013 standard, which strictly stipulates the specifications of all aspects of production, especially the pipeline system in the process of product delive.
: GB 29923-2013 National Food Safety Standard Good Manufacturing Practice for Formulas for Special Medical Purposes GMP 2 The food contact surface should be smooth, without dents or cracks to reduce the accumulation of food debris, dirt and organic matt.
3 The inner wall of the equipment in contact with the material should be smooth, flat, free of dead ends, easy to clean and resistant to corrosion, and the inner surface layer should be made of materials that do not react with the material, release particles and absorb the materi.
Automatic welding technology removes quality blind spo.
According to the national standard, various manufacturers have generally improved the material standards, such as the internal Ra value of pipes and fittings should not be lower than 8 microns, e.
; but for special medical food, the quality requirements and products of medicine are closer to Attributes, combined with Kinglai's decades of experience in the pharmaceutical industry, it is easier for everyone to ignore a factor that causes dead ends and affects products - pipeline connecti.
The methods of pipeline connection include welding, flange connection and arbitrary connecti.
Among these connection methods, the greatest hidden danger to quality is welding: During the on-site construction process, the number of weld beads welded on stainless steel pipelines, valves, tanks and other products Huge (at least 2000 for a typical liquid milk workshop), without consistent weld quality, every weld pass will be a contamination risk poi.
Welding defects include: dislocation, depressions, protrusions, oxidation, cracks, non-penetration, pores, undercuts,e.
According to standards such as ASME BPE and EHEDG, we found that in order to achieve stable quality, in addition to high-quality materials, the most important factor is the welding meth.
At present, both the pharmaceutical and food industries in Europe and the United States have achieved automatic welding construction; the domestic biopharmaceutical industry has all achieved automatic welding construction, but the application of automatic welding in the food industry is still at a low ra.
Compared with automatic welding, manual welding has huge hidden dangers in the quality of manual welding: the manual welding method is greatly affected by human factors, and the skill level of each welder is differe.
The cracks in the weld bead are mainly due to the uneven speed of manual welding and the uneven cooling time of the welding part, and the shrinkage stress will increase, which will cause cracks in the we.
Hazards - Corrosion Stainless steel suffers from corrosion too! In corrosive environments, changes in stainless steel purity can easily cause corrosi.
In the production and processing of stainless steel, there are few processes other than welding that will cause changes in material purity, so this type of corrosion is also called weld corrosion (intergranular corrosio.
The stainless steel that produces intergranular corrosion, when subjected to stress, will fracture along the grain boundary and the strength will almost completely disappear, which is one of the most dangerous forms of damage to stainless ste.
Intergranular corrosion can occur in the heat-affected zone (HAZ) of welded joints, welds or fusion lines, respective.
Intergranular corrosion generated on fusion lines is also called knife line corrosion (KL.
Weld corrosion (intergranular corrosion) is a type of localized corrosion that destroys the bonds between grai.
After the corrosion occurs, the surface of the metal still maintains a certain metallic luster, and there is no sign of damage in the short term, but the bonding force between grains is significantly weakened, and the mechanical properties deteriora.
In severe cases, light vibration and material flow will break into powder, which is the main source of iron filings in the piping syst.
Magnetic filter Magnetic rod that adsorbs a large amount of iron filings A multinational dairy company's new production line in China is plagued by iron filings impuriti.
The situation was alleviated after the installation of Kinglai magnetic filte.
In the process of stainless steel welding, the Xinlai magnetic filter needs the following measures to prevent welding corrosion: Adjust the chemical composition of the weld and add stabilizing elements to reduce the possibility of intergranular corrosion; The carbides precipitated in the heat-affected zone close to the weld are minimized; ·Use high-quality plates with good roundness and equal thickness of the tube wall; ·When welding, all connecting parts are required to reach the melting point at the same time; ·Control in the dangerous temperature area long residence time, prevent overheating, fast welding and fast cooli.
Therefore, in addition to using high-quality clean pipes, it is also necessary to abandon the traditional manual welding, and the automatic welding is controlled by computer digital, which meets the requirements of the "Welding Procedure Specification WPS", which can eliminate the dislocation, depression and cracks of the weld bead caused by human unstable facto.
, corrosion and other hazar.
Welding procedure specification WPS (Welding procedure specification) Welding procedure specification is a written document used to provide guidance for welders to manufacture welds in accordance with specificatio.
Welding must be completed according to WPS conditions: suitable base metal, required preheating, welding speed, Current, voltage, distance, e.
These conditions are called welding variabl.
On October 22, 2021, the Secretariat of the National Food Safety Standards Review Committee issued the "Good Manufacturing Practice for Food Safety National Standards for Special Medical Purposes" (Draft for Comment), which once again reflects China's emphasis on the special medical food indust.
A complete system of regulations and standards has been further established, and strict regulatory requirements have been implemented for .
Increased control of chemical contamination should take steps to reduce residues of cleaners and sanitizers on food contact surfaces of equipment and containers and conduct regular residue monitoring; clarify that chloric acid should be regularly monitored for food contact surfaces where chlorinated cleaners and sanitizers are used Residues such as salt, avoid food safety risks! Increase the prevention requirements for allergen contamination For products targeting allergic people, measures to prevent allergen contamination should be taken, and their effectiveness should be verifi.
of allergens, effective cleaning should be performed and the cleaning effectiveness verifi.
In recent years, "vanillin" incidents have occurred frequently in milk powd.
Most of the milk powders for infants and young children in the first, second and third stages are produced on the same li.
The incomplete cleaning of the pipeline leads to residual pollution, which causes dairy companies to suffer huge loss.
Increase the requirements for commercial sterili.
Appendix C adds the requirement that "the process method of thermal sterilization aseptic filling or final thermal sterilization after sealing should be selected to achieve the purpose of commercial sterility"; increase the requirements for commercial sterility inspection, correction, recording, e.
The above existing or new terms put forward very high requirements on the smoothness of the equipment and the food contact surface in the production process of special medical fo.
Only by combining strict management system can the hidden safety hazards in the production process of special medical food be eliminat.
Kinglai Group helps the FSMP industry to upgrade "The formulation of China's FSMP-related regulations draws on EU standards, and EU standards can be said to be very strict and complete standar.
" —— Risk Assessment Department of the National Food Safety Risk Assessment Center Director Xu Haibin For the food industry, whether it is product approval, clinical trials, formulation, analysis, testing, production process safety management, e.
, special medical food has high requiremen.
It can be said that food companies enter the field of special medical fo.
Almost equivalent to transitioning into the pharmaceutical indust.
Jinlai Group is currently one of the few international high-quality applied material suppliers with complete technology in the same industry in Chi.
Clean products help dairy enterprises to upgrade to the special medical food industry! Kinglai stainless steel piping system can provide sufficient safety - that is to eliminate the release of harmful substances, and ensure the smoothness of the contact surface between equipment and food from the following aspects: Perfect system certification In the field of sanitary fluids, Kinglai Group has The most complete system certification in the world, and it is also an enterprise that has obtained double certification of ASME BPE pipe fittin.
Excellent clean products Kinglai Group's main products include pumps, valves, pressure vessels, heat exchangers, pipes, pipe fittings, e.
, which are key components of high-quality clean equipment syste.
Smoothness, seamless interior and safety are the hallmarks of Kinglai Group accessori.
Clean Pipe & Pipe Fittings Kinglai Group is a double-certified enterprise for ASME BPE pipe fittings, providing professional fittings and fittings for food and medicine fiel.
The inner surface finish of clean pipe fittings can be achieved at Ra<375μm, which is beneficial to improve the cleanliness of the pipe, and it is not easy for bacteria to rema.
At the same time, it also helps to maintain excellent corrosion resistance and long service li.
Sanitary/sterile valve The valve body is made of ASMT 316L/304 stainless steel, and the inner surface Ra value is ≤8.
The sanitary pump adopts ultra-high clean design, and the surface finish of the pump chamber, impeller, gland, e.
in contact with the liquid is below Ra5 micron; no dead angle design, and the radius of the concave corner is more than 6 mm to ensure the medium or cleaning liqu.
Smooth flow without residue, Kinglai pump has the function of dismantling and draining each part, without dead angle, and different draining methods can be customized according to customer nee.
Advanced design and connection method Automatic welding to eliminate quality blind spots for dairy enterprises Automatic welding eliminates human factors, and there will be no defects such as dislocation, depression, non-penetration, internal and external protrusions, and no residues of materials, CIP cleaning fluid, and microorganis.
After CIP cleaning, due to the depression or protrusion of the manual weld bead, the cleaning fluid cannot be self-drained in the pipeline, and there are material residu.
Manual weld bead VS automatic weld bead
Food for Special Medical Purposes · New Track From 2016 to now, a total of 83 types of special medical food in China have been registered, including 46 types of formula food for special medical purposes and 37 types of special medical food for infan.
Feihe, Nestle, Abbott, Danone, Mead Johnson, Beingmate, and Shengyuan have all deployed special medical fo.
Food for Special Medical Purposes High Requirements Special medical food is a kind of food with extremely high requirements for food safety and strong regulatio.
Although the current volume is small, the production management of special medical food requires that the production units are linked togeth.
Everythi.
Food for Special Medical Purposes · Good prospects China is a country with a large population and an aging populati.
With the development of clinical nutrition, the demand for such food by clinicians and patients is increasing, and the future development potential of special medical food is also very gre.
The special medical food industry is expected to usher in further breakthroughs under market norms and become the third largest health "blue ocean" in China's general health field after drugs and equipme.
Judging from the number of approved products for FSMP registration, the number of domestic companies and foreign companies is comparable, with domestic products accounting for 59% of the tot.
Pharmaceutical companies and dairy companies are currently the main force in the industry, especially dairy companies have expressed their interest in FS.
of great enthusia.
The special medical food industry not only pays attention to the research and development capabilities of enterprises, but also tests the comprehensive capabilities of enterprises in various aspects such as production and quality contr.
Special medical food not only needs to meet the needs of people with special nutritional needs under pathological conditions, such as patients with diabetes, kidney disease, and other diseases or surgical rehabilitation personnel, but also includes people with special nutritional needs under non-pathological conditions, such as pregnant women, infants and young children , the elderly,e.
Therefore, different types of special medical food have the same strict requirements in terms of quality and safe.
In view of the strict requirements for the quality of special medical products, it is necessary to have high-standard and high-quality performance in all aspects of producti.
Therefore, the state has promulgated the GB29923-2013 standard, which strictly stipulates the specifications of all aspects of production, especially the pipeline system in the process of product delive.
: GB 29923-2013 National Food Safety Standard Good Manufacturing Practice for Formulas for Special Medical Purposes GMP 2 The food contact surface should be smooth, without dents or cracks to reduce the accumulation of food debris, dirt and organic matt.
3 The inner wall of the equipment in contact with the material should be smooth, flat, free of dead ends, easy to clean and resistant to corrosion, and the inner surface layer should be made of materials that do not react with the material, release particles and absorb the materi.
Automatic welding technology removes quality blind spo.
According to the national standard, various manufacturers have generally improved the material standards, such as the internal Ra value of pipes and fittings should not be lower than 8 microns, e.
; but for special medical food, the quality requirements and products of medicine are closer to Attributes, combined with Kinglai's decades of experience in the pharmaceutical industry, it is easier for everyone to ignore a factor that causes dead ends and affects products - pipeline connecti.
The methods of pipeline connection include welding, flange connection and arbitrary connecti.
Among these connection methods, the greatest hidden danger to quality is welding: During the on-site construction process, the number of weld beads welded on stainless steel pipelines, valves, tanks and other products Huge (at least 2000 for a typical liquid milk workshop), without consistent weld quality, every weld pass will be a contamination risk poi.
Welding defects include: dislocation, depressions, protrusions, oxidation, cracks, non-penetration, pores, undercuts,e.
According to standards such as ASME BPE and EHEDG, we found that in order to achieve stable quality, in addition to high-quality materials, the most important factor is the welding meth.
At present, both the pharmaceutical and food industries in Europe and the United States have achieved automatic welding construction; the domestic biopharmaceutical industry has all achieved automatic welding construction, but the application of automatic welding in the food industry is still at a low ra.
Compared with automatic welding, manual welding has huge hidden dangers in the quality of manual welding: the manual welding method is greatly affected by human factors, and the skill level of each welder is differe.
The cracks in the weld bead are mainly due to the uneven speed of manual welding and the uneven cooling time of the welding part, and the shrinkage stress will increase, which will cause cracks in the we.
Hazards - Corrosion Stainless steel suffers from corrosion too! In corrosive environments, changes in stainless steel purity can easily cause corrosi.
In the production and processing of stainless steel, there are few processes other than welding that will cause changes in material purity, so this type of corrosion is also called weld corrosion (intergranular corrosio.
The stainless steel that produces intergranular corrosion, when subjected to stress, will fracture along the grain boundary and the strength will almost completely disappear, which is one of the most dangerous forms of damage to stainless ste.
Intergranular corrosion can occur in the heat-affected zone (HAZ) of welded joints, welds or fusion lines, respective.
Intergranular corrosion generated on fusion lines is also called knife line corrosion (KL.
Weld corrosion (intergranular corrosion) is a type of localized corrosion that destroys the bonds between grai.
After the corrosion occurs, the surface of the metal still maintains a certain metallic luster, and there is no sign of damage in the short term, but the bonding force between grains is significantly weakened, and the mechanical properties deteriora.
In severe cases, light vibration and material flow will break into powder, which is the main source of iron filings in the piping syst.
Magnetic filter Magnetic rod that adsorbs a large amount of iron filings A multinational dairy company's new production line in China is plagued by iron filings impuriti.
The situation was alleviated after the installation of Kinglai magnetic filte.
In the process of stainless steel welding, the Xinlai magnetic filter needs the following measures to prevent welding corrosion: Adjust the chemical composition of the weld and add stabilizing elements to reduce the possibility of intergranular corrosion; The carbides precipitated in the heat-affected zone close to the weld are minimized; ·Use high-quality plates with good roundness and equal thickness of the tube wall; ·When welding, all connecting parts are required to reach the melting point at the same time; ·Control in the dangerous temperature area long residence time, prevent overheating, fast welding and fast cooli.
Therefore, in addition to using high-quality clean pipes, it is also necessary to abandon the traditional manual welding, and the automatic welding is controlled by computer digital, which meets the requirements of the "Welding Procedure Specification WPS", which can eliminate the dislocation, depression and cracks of the weld bead caused by human unstable facto.
, corrosion and other hazar.
Welding procedure specification WPS (Welding procedure specification) Welding procedure specification is a written document used to provide guidance for welders to manufacture welds in accordance with specificatio.
Welding must be completed according to WPS conditions: suitable base metal, required preheating, welding speed, Current, voltage, distance, e.
These conditions are called welding variabl.
On October 22, 2021, the Secretariat of the National Food Safety Standards Review Committee issued the "Good Manufacturing Practice for Food Safety National Standards for Special Medical Purposes" (Draft for Comment), which once again reflects China's emphasis on the special medical food indust.
A complete system of regulations and standards has been further established, and strict regulatory requirements have been implemented for .
Increased control of chemical contamination should take steps to reduce residues of cleaners and sanitizers on food contact surfaces of equipment and containers and conduct regular residue monitoring; clarify that chloric acid should be regularly monitored for food contact surfaces where chlorinated cleaners and sanitizers are used Residues such as salt, avoid food safety risks! Increase the prevention requirements for allergen contamination For products targeting allergic people, measures to prevent allergen contamination should be taken, and their effectiveness should be verifi.
of allergens, effective cleaning should be performed and the cleaning effectiveness verifi.
In recent years, "vanillin" incidents have occurred frequently in milk powd.
Most of the milk powders for infants and young children in the first, second and third stages are produced on the same li.
The incomplete cleaning of the pipeline leads to residual pollution, which causes dairy companies to suffer huge loss.
Increase the requirements for commercial sterili.
Appendix C adds the requirement that "the process method of thermal sterilization aseptic filling or final thermal sterilization after sealing should be selected to achieve the purpose of commercial sterility"; increase the requirements for commercial sterility inspection, correction, recording, e.
The above existing or new terms put forward very high requirements on the smoothness of the equipment and the food contact surface in the production process of special medical fo.
Only by combining strict management system can the hidden safety hazards in the production process of special medical food be eliminat.
Kinglai Group helps the FSMP industry to upgrade "The formulation of China's FSMP-related regulations draws on EU standards, and EU standards can be said to be very strict and complete standar.
" —— Risk Assessment Department of the National Food Safety Risk Assessment Center Director Xu Haibin For the food industry, whether it is product approval, clinical trials, formulation, analysis, testing, production process safety management, e.
, special medical food has high requiremen.
It can be said that food companies enter the field of special medical fo.
Almost equivalent to transitioning into the pharmaceutical indust.
Jinlai Group is currently one of the few international high-quality applied material suppliers with complete technology in the same industry in Chi.
Clean products help dairy enterprises to upgrade to the special medical food industry! Kinglai stainless steel piping system can provide sufficient safety - that is to eliminate the release of harmful substances, and ensure the smoothness of the contact surface between equipment and food from the following aspects: Perfect system certification In the field of sanitary fluids, Kinglai Group has The most complete system certification in the world, and it is also an enterprise that has obtained double certification of ASME BPE pipe fittin.
Excellent clean products Kinglai Group's main products include pumps, valves, pressure vessels, heat exchangers, pipes, pipe fittings, e.
, which are key components of high-quality clean equipment syste.
Smoothness, seamless interior and safety are the hallmarks of Kinglai Group accessori.
Clean Pipe & Pipe Fittings Kinglai Group is a double-certified enterprise for ASME BPE pipe fittings, providing professional fittings and fittings for food and medicine fiel.
The inner surface finish of clean pipe fittings can be achieved at Ra<375μm, which is beneficial to improve the cleanliness of the pipe, and it is not easy for bacteria to rema.
At the same time, it also helps to maintain excellent corrosion resistance and long service li.
Sanitary/sterile valve The valve body is made of ASMT 316L/304 stainless steel, and the inner surface Ra value is ≤8.
The sanitary pump adopts ultra-high clean design, and the surface finish of the pump chamber, impeller, gland, e.
in contact with the liquid is below Ra5 micron; no dead angle design, and the radius of the concave corner is more than 6 mm to ensure the medium or cleaning liqu.
Smooth flow without residue, Kinglai pump has the function of dismantling and draining each part, without dead angle, and different draining methods can be customized according to customer nee.
Advanced design and connection method Automatic welding to eliminate quality blind spots for dairy enterprises Automatic welding eliminates human factors, and there will be no defects such as dislocation, depression, non-penetration, internal and external protrusions, and no residues of materials, CIP cleaning fluid, and microorganis.
After CIP cleaning, due to the depression or protrusion of the manual weld bead, the cleaning fluid cannot be self-drained in the pipeline, and there are material residu.
Manual weld bead VS automatic weld bead
