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[Pharmaceutical Network Exhibition Report] In the pharmaceutical production process, water is an indispensable raw material, and it is widely used in large quantities
.
In order to improve the quality of pharmaceuticals, China has put forward increasingly strict requirements for pharmaceutical water
.
For example, the 2020 version of the "Chinese Pharmacopoeia", which has been implemented since December 30, 2020, has included "purified water", "water for injection" and "sterilized water for injection" three kinds of pharmacopoeia water and related indicators, and put forward more requirements for pharmaceutical water.
high demands
.
With the implementation of the new Pharmacopoeia, China's pharmaceutical industry has entered a more scientific and systematic new period
.
Under the implementation of the new version of the Pharmacopoeia, pharmaceutical water requires water to participate in the entire process of pharmaceutical production, which directly affects the quality of drugs.
Pharmaceutical manufacturers must ensure that the quality of pharmaceutical water meets the requirements of the Pharmacopoeia
.
The Chinese Pharmacopoeia has made clear regulations on pharmaceutical water, including drinking water, purified water, water for injection and sterile water for injection.
Among them, it is mentioned that the purified water used in the pharmaceutical industry can be used as a solvent or test for the preparation of ordinary pharmaceutical preparations.
Water can be used as the extraction solvent for decoction pieces used in traditional Chinese medicine injections, eye drops and other sterilized preparations; solvent or diluent for the preparation of oral and external preparations; washing water for utensils used for non-sterile preparations; used as decoction pieces for non-sterile preparations Extraction solvent,
etc.
Compared with the 2015 version of the Pharmacopoeia, the indicators of the new version of the Pharmacopoeia for purified water still include items such as properties, pH/pH, ammonia, non-volatiles, nitrates, nitrites and heavy metals
.
Compared with the index requirements of the European and American Pharmacopoeia for purified water, the new version of the Pharmacopoeia is closer to the European Pharmacopoeia in various indicators, which also means that the requirements of the new version of the Pharmacopoeia for purified water are basically in line with the level, and the requirements are becoming stricter
.
In addition to pure water standards, the new version of the Pharmacopoeia has stricter safety requirements for drugs, and more mature testing technologies are used in drug quality control
.
Among them, in the four general rules of the 2020 edition of the Pharmacopoeia catalogue, pharmaceutical water is listed in the general rules for preparations, and under the "Determination of Physical Constants", the four general rules mention the method for measuring the conductivity of pharmaceutical water and the method for measuring total organic carbon in pharmaceutical water.
This also means that the new version of the Pharmacopoeia has further improved the requirements for pharmaceutical water
.
Regarding the quality requirements of purified water for pharmaceuticals, although the new version of the Chinese Pharmacopoeia does not clearly specify which preparation method to use, it clearly requires that drinking water that meets the official standard should be used as raw water for the preparation of purified water.
After distillation, ion exchange, reverse osmosis method and other suitable methods
.
And the new version of the Pharmacopoeia has made provisions on purified water quality, pH value, nitrate, nitrite, ammonia, electrical conductivity, total organic carbon and other indicators
.
After the implementation of the new version of the Pharmacopoeia, the water quality of 18.
2 megohms is only the threshold for the water requirements of high-precision instruments; TOC, heavy metal impurity content and other indicators need to be comprehensively considered and comprehensively evaluated; for ICP-MS water, on the one hand, the water quality needs to reach ultrapure water.
In addition to the standard, on the other hand, the content of metal impurities in the product water must also reach the ppt or even sub-ppt level
.
The ultrapure water equipment industry has ushered in new opportunities.
With the further requirements of the new Pharmacopoeia for pharmaceutical water requirements, China's pharmaceutical enterprises have also responded positively, not only for the stricter requirements for pure water equipment, but also for technologically advanced ultrapure water equipment.
expand
.
As far as pure water equipment is concerned, there are currently a large number of pure water equipment on the market.
According to statistics, by the end of 2017, there were nearly 1,600 ultra-pure water machine manufacturers in China, and they were still growing at a rapid rate of 30%
.
It is worth noting that although the number of pure water equipment is large, there are not many ultrapure water equipment that can meet the requirements of the new pharmacopoeia.
Therefore, the ultrapure water equipment industry with high quality and high technology content will usher in a huge space for development
.
Ultrapure water equipment is a kind of equipment that combines reverse osmosis water treatment equipment with electrodeionization (EDI) equipment and polishing mixed bed to prepare ultrapure water.
This is a new process for preparing ultrapure water.
Compared with traditional methods, ultrapure water equipment has many advantages and can continuously and stably prepare high-quality ultrapure water
.
After the implementation of the new Pharmacopoeia, the pharmaceutical ultrapure water equipment industry will be pushed to the forefront by virtue of its advantages
.
Nowadays, many ultrapure water equipment companies are making efforts to strengthen the innovation and transformation of equipment, such as improving water quality standardization, system intelligence, humanized design, green production, etc.
, to meet the new needs of pharmaceutical companies and solve pharmaceutical problems.
Enterprise pain points, difficult problems
.
For example, Zhejiang Dongda has developed a continuous electrodeionization device (EDI), which is a green revolution in the field of high-purity water preparation.
Its equipment can completely replace imported membrane blocks and is widely used in medicine and other fields
.
The so-called EDI, also known as continuous electric desalination technology, can continuously produce high-quality ultrapure water without acid and alkali chemical regeneration in the water production process.
It has the advantages of stable effluent water quality, compact structure and easy operation.
The emergence of EDI has brought a qualitative leap to the ultrapure water industry
.
Coincidentally, Yileke is also shining in the field of ultrapure water equipment.
The total water production of its products in China in 2020 will reach nearly 80,000 tons per hour
.
In order to provide better services for Chinese pharmaceutical companies, Elec said that in 2021, it will be committed to expanding the application of EDI electrodeionization technology, and will continue to bring high-quality products, careful technical support, and considerate after-sales service to our customers.
Better user experience
.
Purified water equipment, as an important carrier in the whole process of material input in drug production in the pharmaceutical industry, has a direct impact on the quality and efficiency of drug production
.
In order to better meet the needs of the new version of the Pharmacopoeia and produce high-quality, high-efficiency purified water, ultra-purified water equipment companies also need to comprehensively consider the applicability, cleanliness, convenience, and anti-pollution properties of purified water equipment in the pharmaceutical industry.
, so as to better seize market opportunities and seek long-term sustainable development
.
.
In order to improve the quality of pharmaceuticals, China has put forward increasingly strict requirements for pharmaceutical water
.
For example, the 2020 version of the "Chinese Pharmacopoeia", which has been implemented since December 30, 2020, has included "purified water", "water for injection" and "sterilized water for injection" three kinds of pharmacopoeia water and related indicators, and put forward more requirements for pharmaceutical water.
high demands
.
With the implementation of the new Pharmacopoeia, China's pharmaceutical industry has entered a more scientific and systematic new period
.
Under the implementation of the new version of the Pharmacopoeia, pharmaceutical water requires water to participate in the entire process of pharmaceutical production, which directly affects the quality of drugs.
Pharmaceutical manufacturers must ensure that the quality of pharmaceutical water meets the requirements of the Pharmacopoeia
.
The Chinese Pharmacopoeia has made clear regulations on pharmaceutical water, including drinking water, purified water, water for injection and sterile water for injection.
Among them, it is mentioned that the purified water used in the pharmaceutical industry can be used as a solvent or test for the preparation of ordinary pharmaceutical preparations.
Water can be used as the extraction solvent for decoction pieces used in traditional Chinese medicine injections, eye drops and other sterilized preparations; solvent or diluent for the preparation of oral and external preparations; washing water for utensils used for non-sterile preparations; used as decoction pieces for non-sterile preparations Extraction solvent,
etc.
Compared with the 2015 version of the Pharmacopoeia, the indicators of the new version of the Pharmacopoeia for purified water still include items such as properties, pH/pH, ammonia, non-volatiles, nitrates, nitrites and heavy metals
.
Compared with the index requirements of the European and American Pharmacopoeia for purified water, the new version of the Pharmacopoeia is closer to the European Pharmacopoeia in various indicators, which also means that the requirements of the new version of the Pharmacopoeia for purified water are basically in line with the level, and the requirements are becoming stricter
.
In addition to pure water standards, the new version of the Pharmacopoeia has stricter safety requirements for drugs, and more mature testing technologies are used in drug quality control
.
Among them, in the four general rules of the 2020 edition of the Pharmacopoeia catalogue, pharmaceutical water is listed in the general rules for preparations, and under the "Determination of Physical Constants", the four general rules mention the method for measuring the conductivity of pharmaceutical water and the method for measuring total organic carbon in pharmaceutical water.
This also means that the new version of the Pharmacopoeia has further improved the requirements for pharmaceutical water
.
Regarding the quality requirements of purified water for pharmaceuticals, although the new version of the Chinese Pharmacopoeia does not clearly specify which preparation method to use, it clearly requires that drinking water that meets the official standard should be used as raw water for the preparation of purified water.
After distillation, ion exchange, reverse osmosis method and other suitable methods
.
And the new version of the Pharmacopoeia has made provisions on purified water quality, pH value, nitrate, nitrite, ammonia, electrical conductivity, total organic carbon and other indicators
.
After the implementation of the new version of the Pharmacopoeia, the water quality of 18.
2 megohms is only the threshold for the water requirements of high-precision instruments; TOC, heavy metal impurity content and other indicators need to be comprehensively considered and comprehensively evaluated; for ICP-MS water, on the one hand, the water quality needs to reach ultrapure water.
In addition to the standard, on the other hand, the content of metal impurities in the product water must also reach the ppt or even sub-ppt level
.
The ultrapure water equipment industry has ushered in new opportunities.
With the further requirements of the new Pharmacopoeia for pharmaceutical water requirements, China's pharmaceutical enterprises have also responded positively, not only for the stricter requirements for pure water equipment, but also for technologically advanced ultrapure water equipment.
expand
.
As far as pure water equipment is concerned, there are currently a large number of pure water equipment on the market.
According to statistics, by the end of 2017, there were nearly 1,600 ultra-pure water machine manufacturers in China, and they were still growing at a rapid rate of 30%
.
It is worth noting that although the number of pure water equipment is large, there are not many ultrapure water equipment that can meet the requirements of the new pharmacopoeia.
Therefore, the ultrapure water equipment industry with high quality and high technology content will usher in a huge space for development
.
Ultrapure water equipment is a kind of equipment that combines reverse osmosis water treatment equipment with electrodeionization (EDI) equipment and polishing mixed bed to prepare ultrapure water.
This is a new process for preparing ultrapure water.
Compared with traditional methods, ultrapure water equipment has many advantages and can continuously and stably prepare high-quality ultrapure water
.
After the implementation of the new Pharmacopoeia, the pharmaceutical ultrapure water equipment industry will be pushed to the forefront by virtue of its advantages
.
Nowadays, many ultrapure water equipment companies are making efforts to strengthen the innovation and transformation of equipment, such as improving water quality standardization, system intelligence, humanized design, green production, etc.
, to meet the new needs of pharmaceutical companies and solve pharmaceutical problems.
Enterprise pain points, difficult problems
.
For example, Zhejiang Dongda has developed a continuous electrodeionization device (EDI), which is a green revolution in the field of high-purity water preparation.
Its equipment can completely replace imported membrane blocks and is widely used in medicine and other fields
.
The so-called EDI, also known as continuous electric desalination technology, can continuously produce high-quality ultrapure water without acid and alkali chemical regeneration in the water production process.
It has the advantages of stable effluent water quality, compact structure and easy operation.
The emergence of EDI has brought a qualitative leap to the ultrapure water industry
.
Coincidentally, Yileke is also shining in the field of ultrapure water equipment.
The total water production of its products in China in 2020 will reach nearly 80,000 tons per hour
.
In order to provide better services for Chinese pharmaceutical companies, Elec said that in 2021, it will be committed to expanding the application of EDI electrodeionization technology, and will continue to bring high-quality products, careful technical support, and considerate after-sales service to our customers.
Better user experience
.
Purified water equipment, as an important carrier in the whole process of material input in drug production in the pharmaceutical industry, has a direct impact on the quality and efficiency of drug production
.
In order to better meet the needs of the new version of the Pharmacopoeia and produce high-quality, high-efficiency purified water, ultra-purified water equipment companies also need to comprehensively consider the applicability, cleanliness, convenience, and anti-pollution properties of purified water equipment in the pharmaceutical industry.
, so as to better seize market opportunities and seek long-term sustainable development
.
