He Zhizhen: Pharmaceutical machinery is not only selling equipment, but also process technology.

Guide: Once ignored by everyone, he is well aware of the principle, the results.
and even now the pharmaceutical industry has a "difficult and difficult to find a creative" argument.
is naturally full of confidence in creative equipment: "We are comparable in strength to international advanced equipment, and there are their own inventions and patents that they do not have."
" However, even so, He Zhizhen believes that Genesis is not only doing equipment trading, but also, equally important, technology extension services.
He Zhizhen Zhi Electromechanical Technology Development (Jiangsu) Co., Ltd. Chairman /01/consistency evaluation is not done well, may be a device problem? As chairman of the pharmaceutical equipment company, He Zhizhen enjoys communicating with pharmaceutical companies.
time, when he spoke to a pharmaceutical company, he was having a headache about a variety of consistency evaluations.
talk about the relationship between equipment and consistency, they made a bet, let He Shizhen they spent a year and a half, still with the reference preparation dissolved out of about 20% of the varieties to take back to use the creative equipment to do, and asked not to change its original prescription process.
", "It's a challenge for me, after all, the key is the medicine itself."
, " he admits, but is also confident, "If they had done it with domestic equipment before, then, with my equipment, there would have been improvements."
"pharmaceutical companies also boldly set a "gambling capital" - "as long as the increase dissolved out of 3 points, I think the equipment is very important;
"He Zhizhen back to organize the experimental staff in accordance with the other side's prescription process and related process parameters, as well as combined with their own equipment experience, only made a batch of pilot, the results of pharmaceutical enterprises go back to sampling test inglision curveall on.
", "Not our cattle, but good equipment plus the right process can do it.
" he attributed it to the equipment.
after communicating with many pharmaceutical companies, he found that there are indeed many cases, the product's raw materials, prescriptions, processes have been very good, but consistency evaluation has been doing badly, and the team tried all kinds of ways, but did not consider may be equipment problems, did not choose a better equipment to do comparison.
/02/Device and equipment, how big is the difference? After shocking the other side through the results of the experiment, He Zhizhen slowly explained: "There are differences between the equipment, different design principles, different methods of data acquisition, control of detection, different operation control and processing power, the performance results of the final equipment operation is very different."
", he continued, explaining the above-mentioned case: in fact, the release of improved, particle quality is the key.
previously, the pharmaceutical company with the existing fluidized bed to make the uniform distribution of particle size is not good, will produce a part of fine powder, part of the particles, and a part of the rigid particles, particle density is uneven, so that the release is a problem.
in addition, when pressing the sheet, the filling of the load is also different, the pressure is also relatively large fluctuations, these have an impact on the results.
a good fluidized bed, first of all its air flow distribution is even.
" is important.
," he stressed.
the flow of the air distribution is uneven fluidized bed, in use will appear the phenomenon of the edge of the heap, can only increase the amount of air to do;
result naturally causes uneven particle size distribution.
a good device also needs to be intelligently tracked by wind volume.
especially the adhesive sprayed in so that the material wet, filter bag slowly have a small amount of dust blockage when the air volume will be significantly reduced.
without intelligent tracking, the device's ability to dry will decline, so that the resulting particles will be different in nature as normal flowing.
in addition, the pressure of spray gun atomization is also important.
this is a means of controlling the size of droplets.
", "the fluidific bed is a multi-technical system, any failure to do a good job will affect the final results.
, therefore, when designing a device, it is necessary to balance a range of factors.
," he explained.
good equipment can "save money" in addition to producing good products.
is first and foremost energy consumption.
" light is electricity and steam costs, granulation with the general fluidized bed can save 1/3-2/3;
" he counted.
second, good equipment can save material.
He Shizhen has done a case, is a treatment of stomach ulcers of the compound enzyme preparation, the finished product is filled at the price. there is a problem with the price of the original production equipment
.
used his equipment, the price increased by about 20%, the final finished product rate also increased by 20%.
"If a billion sales a year, 20 points, it is 20 million."
" there are many more cases.
good equipment is different in its manufacture.
he gave an example.
make a circle, use a plate to roll into a circle, or use a few steel plates to piece together a circle, or a solid material to key a circle.
different ways of manufacturing, perhaps the effect is the same in the first.
but over time, the whole processed circle and the steel plate round, it is clear that the latter will deform, produce offsets, and ultimately affect the quality and operational performance of the equipment.
/03/not only equipment, but also the overall solution for creative equipment, He Shizhen is naturally full of confidence: "We are compared with international advanced equipment, the strength of the equivalent, and there are their own inventions and patents are they do not have."
" However, even so, He Zhizhen believes that Genesis is not only doing equipment trading, but also, equally important, technology extension services.
he admits that Genesis's founding team came out of the drug factory, so when they think about it, they tend to be more comprehensive than traditional equipment providers.
, for example, how do pharmaceutical production processes be optimized? What should be equipped with the device? How should the logistics and flow of people on the production line be combined? How are the parameters set? How is the device automatically controlled? ...... The answer to the above questions may be different for different drugs.
come across products they've ever done, and it's all natural.
if they encounter something they haven't done, they'll do the experiment, get answers from the experiment, and add it to the final device solution.
" tailor-made, is the process equipment.
," he said.
Creative has thus broken through the status of equipment supplier.
they have proposed the concept of an oral solid formulation "whole solution" to provide customers with more and more complete extended technical services outside of the equipment.
" our services cover the entire process of small trial, pilot, and production.
," he stressed.
"overall solution" well done, the customer's productivity will improve, product quality will improve, energy consumption will be reduced, costs will be reduced ... The end result must be to make customers make more money.
"so, don't look at our good equipment, expensive equipment, but because of this 'whole solution', for customers, this is certainly a more cost-effective choice."
" but the concept is new, its popularity and acceptance will take time and effort.
in order to do a good job of this, He Zhizhen in the existing small test, pilot laboratory on the basis of the establishment of a more perfect small test, pilot base and can accommodate 250 people ladder classroom, he hopes to build it into a training base for the government, for pharmaceutical companies and CRO companies to tell the principleof of equipment, combined with the nature of the original accessories how to establish process ideas, structure key parts, as well as oral solid preparations "overall solution" and so on.
" domestic pharmaceutical equipment has not yet formed a very strong brand, just like in the Spring and Autumn Warring States.
I hope Genesis will move in the direction of industry leaders.
this is my wish.
," he said.
/04/Continuous Production, the Industrial Revolution in Intelligent Manufacturing is on the industrial manufacturing 4.0 that the manufacturing industry is experiencing - Smart Manufacturing.
He Shizhen and Genesis have been exploring.
" is currently working with well-known domestic universities to carry out a number of topics, the introduction of foreign testing technology.
"What he wants to do is a new production model called "continuous production".
such as continuous wet legal particles, even weighing do not, bring their own weighing, bring their own mixing;
": "It's a very difficult process.
" he was candid, but insisted, "With these devices, add online testing."
can detect the uniformity of content, particle size and moisture during manufacturing.
also set up a mathematical model to judge the trend of change, to see if it is in the direction of non-conformity, whether it is beyond the controlled range, and according to this automatic adjustment of equipment parameters.
ensure that all indicators of the product are within the qualifying range.
" At present, Genesis has worked with international enterprises, on the basis of independent design and development, the introduction, integration of technical resources, and independent establishment of a complete set of control software.
", "the future of continuous production is stable, software also has, how to combine with China's laws and regulations to establish drug production standards, which there are many research needs to be in-depth. Compared with the
"continuous production and current production mode, the difference in regulation is mainly a lot number problem.
, therefore, regulations need to be adjusted to accept continuous production.
" it could take three or five years.
only if we do this seriously can we promote the relevant departments to speed up the approval.
"because there is no data, no standards, no verification of things to the regulatory authorities."
can be seen, continuous production is a big issue, it is not easy to do.
and his reason stood out was simple: "Continuous production can solve many problems."
" such as less room, because weighing, granulation, drying, mixing, pressure plate, etc. combined into a line installed in a room on it;
such as unmanned, closed transfer, no dust, coupled with the corresponding means of monitoring and testing, then the quality of drug production indicators further quantified and online testing, analysis and control, so that the production process throughout monitoring, which will make the quality of drugs more stable.
will be the post-testing link in advance, to reduce the risk of testing non-conforming products batch scrap.
", "intelligent manufacturing is an inevitable trend.
its core, the most difficult thing to do is to combine products and equipment, and use big data intelligent judgment of the quality of the product.
" "This is another industrial revolution!" "He Shizhen is honored to be in it.
based on the existing scientific and technological basis to establish Changzhou City Drug Solids Intelligent Process Engineering Technology Research Center, initiative adhere to the development of science and technology-oriented, intelligent intelligence as the core, committed to the pharmaceutical production process and equipment machinery manufacturing processing, industrial automation control, data collection, automated judgment, parameter release and other combination, for pharmaceutical companies to provide oral solids preparation of a full set of intelligent process solutions research work.
/05/conclusion about pharmaceutical equipment, He Zhizhen as a number of real.
where everyone has been ignored, he knows the principle and the result.
and even now the pharmaceutical industry has a "difficult and difficult to find a creative" argument.
in He Shizhen's view, pharmaceutical equipment is constantly evolving.
this is not only related to the continuous progress of equipment technology, more importantly, the country has developed a higher quality of drugs, the need son of safe and effective drugs, the pharmaceutical industry must be high-quality and rapid development, the need for pharmaceutical equipment to constantly innovate new technologies to meet the needs of the pharmaceutical industry development.
" this time will do more and more taste, more do more feelings, do pharmaceutical machinery is meaningful.
," he said.
.