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Kinglai Group - Escort for Special Medical Food Nanjing·Special Medical Food Experience Sharing Conference 2022 Conference on Technical Key Points of Registration and Review of Formula Foods for Special Medical Purposes and On-site Inspection and Experience Sharing Session of Approved Enterprises The development of China's special medical food market is still in its infancy At this stage, the relevant systems have been continuously improved, and some domestic enterprises have misunderstood the products and registration of special medical products, and failed to accurately interpret national policies and grasp the specific requirements of registration documen.
status q.
In order to effectively solve the above problems, relevant review experts and industry experts, as well as the R&D leaders of approved special medical food enterprises, attended the meeting to share their application experience and help enterprises understand the problems encountered in special medical registrati.
In the courses on the standards and development of formula food for special medical purposes, on-site inspection of special medical food, e.
, in addition to emphasizing the importance of formula, experts all pointed out that the stability of special medical food is also the top priority for the success of registration aud.
Stability includes all aspects of formula design and production of special medical fo.
Stability requirements Is the formulation plan reasonable? Is the production process and equipment stable? Is the quality control stable? Is the quality of multiple batches of sampling samples stable? Does the product quality remain stable after a certain period of production? ……………………………… EHEDG European Hygienic Engineering & Design Group EHEDG (European Hygienic Engineering & Design Group) The opinions of various experts coincide with the philosophy of Kinglai Group: that is, the food manufacturing process moves closer to the pharmaceutical process standards, and by improving Production equipment cleanliness standards to meet the needs of improving food safety and maintaining stable quali.
This time, two experts, Guo Zhifeng and Zhou Xiuming from Kinglai Group, combined theory (the significance of EHEDG design for the safe production of special medical food) with practice (the application case of EU clean engineering (ASME BPE / EHEDG) design in Kinglai domestic and foreign projects) two It expounds the important effects of orbital automatic welding technology, self-draining design, and surface roughness Ra value on improving product quality and ensuring stable producti.
EHEDG The European Hygienic Engineering Design Group (EHEDG), established in 1989, is a non-profit alliance of equipment manufacturers, food producers, food industry suppliers, research institutes and universities, public health agencies and government organizatio.
The main goal of EHEDG is to promote safe food by improving the hygienic engineering design of all food production stag.
The main objective is to avoid microbial contamination of food: Contamination of food can come from raw materials, but also from processing and packagi.
If equipment is poorly hygienically designed, it will be difficult to cle.
Dirt or raw material may remain in the weld bead and inside equipment with high surface roughne.
Self-draining design According to the requirements of EHEDG certification, the surface or pipeline of Kinglai Group should be self-emptying or emptying and easy to cle.
Horizontal surfaces should be avoided, and the design should have inclined angle requiremen.
Kinglai pump has the function of dismantling and draining each part, without dead angle, and can customize different draining methods according to customer nee.
Surface roughness Surface roughness: refers to the small spacing and small peak-to-valley unevenness on the surface of the produ.
The distance (wave pitch) between the two wave crests or two wave troughs is very small (below 1mm), which belongs to the micro-geometric err.
The smaller the surface roughness, the smoother the surfa.
Common food pathogens Individual size Listeria: Individual size is 5μm-0μm Salmonella: Individual size is 5μm-6μm Staphylococcus aureus: Individual size is 8μm Escherichia coli .
coli) is Escherichia coli Representative bacteria of the genus Escherichia: the individual size is about 5μm-0μm Enterobacter sakazakii: the individual size is 6--0μm long and 3--0μm wide The Ra value of the inner surface of the device is lower than the bacterial size, which is beneficial to Improve pipe cleanliness! With innovative MP and EP surface treatment technology, Kinglai Group makes the surface roughness of BPE series products reach Ra≤5μm to Ra≤375.
If required, the minimum value of Jinlai electropolishing can reach Ra12μm (customize.
The domestic standard Wang Dan National Dairy Engineering Technology Research Center experts in China's "Pharmaceutical GMP Guide-2010 Edition", "Good Manufacturing Practice for Formulas for Special Medical Purposes-2013", and "Detailed Rules for the Review of Production Licenses for Formulas for Special Medical Purpose.
Production equipment and food contact surfaces have corresponding requiremen.
"Good Manufacturing Practice for Formulas for Special Medical Purposes-2013" .
Wang Dan introduced the important role of orbital automatic welding in the production process of food and biopharmaceuticals based on the requirements of various standar.
This speech is full of conte.
If you can't be there in person, you can find relevant content in our previous twee.
Kinglai Group · Escort for special medical foodKinglai Orbital Automatic Welding - Helping the Transformation of Special Medical Food IndustryPractical Application of EHEDG - Kinglai Powder BoxBad Manual Welding Bead - Blind Area of Production Quality Kinglai Group mainly Products include pumps, valves, pressure vessels, heat exchangers, pipes, fittings, e.
, which are key components of high-quality clean equipment systems, and are characterized by smoothness, seamless interior and safe.
Kinglai's full line of clean products escorts the food industry for special medical purposes! 1 Kinglai Group · A full line of clean products
status q.
In order to effectively solve the above problems, relevant review experts and industry experts, as well as the R&D leaders of approved special medical food enterprises, attended the meeting to share their application experience and help enterprises understand the problems encountered in special medical registrati.
In the courses on the standards and development of formula food for special medical purposes, on-site inspection of special medical food, e.
, in addition to emphasizing the importance of formula, experts all pointed out that the stability of special medical food is also the top priority for the success of registration aud.
Stability includes all aspects of formula design and production of special medical fo.
Stability requirements Is the formulation plan reasonable? Is the production process and equipment stable? Is the quality control stable? Is the quality of multiple batches of sampling samples stable? Does the product quality remain stable after a certain period of production? ……………………………… EHEDG European Hygienic Engineering & Design Group EHEDG (European Hygienic Engineering & Design Group) The opinions of various experts coincide with the philosophy of Kinglai Group: that is, the food manufacturing process moves closer to the pharmaceutical process standards, and by improving Production equipment cleanliness standards to meet the needs of improving food safety and maintaining stable quali.
This time, two experts, Guo Zhifeng and Zhou Xiuming from Kinglai Group, combined theory (the significance of EHEDG design for the safe production of special medical food) with practice (the application case of EU clean engineering (ASME BPE / EHEDG) design in Kinglai domestic and foreign projects) two It expounds the important effects of orbital automatic welding technology, self-draining design, and surface roughness Ra value on improving product quality and ensuring stable producti.
EHEDG The European Hygienic Engineering Design Group (EHEDG), established in 1989, is a non-profit alliance of equipment manufacturers, food producers, food industry suppliers, research institutes and universities, public health agencies and government organizatio.
The main goal of EHEDG is to promote safe food by improving the hygienic engineering design of all food production stag.
The main objective is to avoid microbial contamination of food: Contamination of food can come from raw materials, but also from processing and packagi.
If equipment is poorly hygienically designed, it will be difficult to cle.
Dirt or raw material may remain in the weld bead and inside equipment with high surface roughne.
Self-draining design According to the requirements of EHEDG certification, the surface or pipeline of Kinglai Group should be self-emptying or emptying and easy to cle.
Horizontal surfaces should be avoided, and the design should have inclined angle requiremen.
Kinglai pump has the function of dismantling and draining each part, without dead angle, and can customize different draining methods according to customer nee.
Surface roughness Surface roughness: refers to the small spacing and small peak-to-valley unevenness on the surface of the produ.
The distance (wave pitch) between the two wave crests or two wave troughs is very small (below 1mm), which belongs to the micro-geometric err.
The smaller the surface roughness, the smoother the surfa.
Common food pathogens Individual size Listeria: Individual size is 5μm-0μm Salmonella: Individual size is 5μm-6μm Staphylococcus aureus: Individual size is 8μm Escherichia coli .
coli) is Escherichia coli Representative bacteria of the genus Escherichia: the individual size is about 5μm-0μm Enterobacter sakazakii: the individual size is 6--0μm long and 3--0μm wide The Ra value of the inner surface of the device is lower than the bacterial size, which is beneficial to Improve pipe cleanliness! With innovative MP and EP surface treatment technology, Kinglai Group makes the surface roughness of BPE series products reach Ra≤5μm to Ra≤375.
If required, the minimum value of Jinlai electropolishing can reach Ra12μm (customize.
The domestic standard Wang Dan National Dairy Engineering Technology Research Center experts in China's "Pharmaceutical GMP Guide-2010 Edition", "Good Manufacturing Practice for Formulas for Special Medical Purposes-2013", and "Detailed Rules for the Review of Production Licenses for Formulas for Special Medical Purpose.
Production equipment and food contact surfaces have corresponding requiremen.
"Good Manufacturing Practice for Formulas for Special Medical Purposes-2013" .
Wang Dan introduced the important role of orbital automatic welding in the production process of food and biopharmaceuticals based on the requirements of various standar.
This speech is full of conte.
If you can't be there in person, you can find relevant content in our previous twee.
Kinglai Group · Escort for special medical foodKinglai Orbital Automatic Welding - Helping the Transformation of Special Medical Food IndustryPractical Application of EHEDG - Kinglai Powder BoxBad Manual Welding Bead - Blind Area of Production Quality Kinglai Group mainly Products include pumps, valves, pressure vessels, heat exchangers, pipes, fittings, e.
, which are key components of high-quality clean equipment systems, and are characterized by smoothness, seamless interior and safe.
Kinglai's full line of clean products escorts the food industry for special medical purposes! 1 Kinglai Group · A full line of clean products
