How medical gels are produced in small batches

Do you remember the gel with which you are smearing the stomach during ultrasound? This is a rather interesting polymer design, which is designed to provide a conductive environment and at the same time a minimum of side noise for the device. Similarly – the gel for ECG, only there the medium is dielectric. Technically, these gels are not very different from a number of gels for hardware cosmetology and for other narrowly specific medical problems. For example, there are gels that are made to penetrate as much as possible through the skin (epidermal layer), they serve as a transport for medicines during, for example, procedures for ultrasonic treatment of the throat in an otolaryngologist.

We have been doing such specific things in Russia for about 20 years. Now I will show the old small-scale production and tell you about a number of its features. We also have a tonnage production for medicine, which is more modern in terms of equipment, but there just orders are more stable and do not require reorganization of the lines every day. But when you need 50 bottles of a certain gel for a year to solve one rare medical problem – this is for us. Let's start.

The main component of gels is water. In a week we produce about 50 tons of finished products and we spend about 150 tons of water. The main thing in water is proper preparation. Reverse osmosis alone reduces the output mass by 2/3. In our case deionized water passes several stages. For any product, the basic steps are the same: it is a preliminary cleaning of the most obvious things, then a carbon filter for large foreign molecules and mechanical particles, then resin filters. As a result, it is cleared of salts and iron. Then, reverse osmosis membranes for small molecules that are smaller than a micron.

Then the water goes to the storage tank.

We need dielectric water, so there is another filter right before using the water in the gel recipe. This is in case if something is added during the storage or transportation of the production. The quality of water we estimate by the absence of mobile ions (conductivity is very small). Therefore, in addition to biological methods, we trivially control its conductivity – we need up to 10 microsimens per centimeter. Although we try to do 2-3.
We tried to regenerate the filters several years ago on our own, but eventually abandoned this process and gave it to the external company. As the filters are contaminated, they simply bring in new ones.

Water, polymer and several other components make the basis of the gel. In the photo above – a container with a swelling polymer. The preparation of the slurry is the swelling of the second main component except water-polymer, which forms this gel mass in any case. Most often, we are talking about polyacrylates for medicine. We use their subspecies – carbomers with long molecules. Chinese gels are made on cheaper polyacrylates, they are less uniform. Near the end of the process, the suspension may look like this.

Then other substances are added to the base. To achieve their uniform distribution in the gel, we use here such reactors (here they are here from 50 to 200 kg).

In the reactors there is mixing of liquids. This process lasts 3-4 hours. The better the composition of the components (the better the polymer) and the more correct and longer the process takes place in the reactor, the more uniformly the gel is obtained. The more uniform the gel, the less noise and loss, for example, during ultrasound.

Each operation is accounted for in ERP and monitored. Each workstation has either a tablet or a computer with a running ERP.

At us control of that occurs on a line, the control of clearing is very important; Production is constantly rebuilding processes, because 25 kilogram and 50 kilogram batch of rare things are being prepared for cosmetology. But the same eye gels (in particular, "Blefarogel") are made in other production in tons: there are fewer manual operations, and instead of 150 products, only about a dozen. Final production – packing by vials.
In the current situation, from a 700 kg reactor through a hose with a screw pump is transferred to the drive and, accordingly, is packed. Vials come in.

The extruders are lowered in them.

The vials are filled and go to the closure.

Then pasting with labels.

Then the finished products pass selective quality control, arbitration samples are saved, and all this goes to the warehouse. But there is a nuance.

A line of Chinese production (there are no others on the market), so it often has to be repaired directly during operation. Accordingly, the box with the tool does not even close and is not carried away, it is under the table by the operators.
On the whole production area there are UV lamps: night – open, day – in the case with rotational ventilation.

In a clean zone, you need to dress up in a protective suit, change your shoes and step on a sticky mat in front of the entrance.

We use various disinfectants. We need indicators on which it is possible to determine whether the concentration of disinfectants has been properly prepared.

The indicator is lowered into the medium, the time is measured on the stopwatch, it is taken out, the color is compared. Important things for hygiene are attached over the sinks.

The warehouse is already a more simple zone for admission, here you can walk in usual change clothes (but not street clothes).

This is a storage room, where there are mechanisms for transferring propylene glycol to production.

Here's how it looks on production through the wall.

At the exit from this room, a microbiological analysis of air is also made.
The refrigerator stores samples and reagents.

Here we are weighing.

There is a development. The main laboratory is elsewhere, but there is a small laboratory in the production process for measuring finished products and quality control. The main laboratory is approximately 50 square meters (now expand), the control laboratory is approximately 15.

And there is an office with a bunch of different samples.

Production is loaded evenly, there are no seasons. When there is no current order, we work in a warehouse, but still almost everything is immediately dismantled.

In this building we are almost 5 years old. The production itself is 20 years old. All this began from the laboratory at the Institute of Medical Polymers. At the Ministry of Health. In this laboratory, the first product development – ultrasonic gels – was made. Doctors met with the polymer. Then it was a rarity. There was perestroika, and there was no longer any choice whatsoever you were studying at universities. It was necessary to rebuild and work. And so they went, went, grew up to such an enterprise, which, in principle, of course, not a monopolist in Russia, but for a very long time our gel was unique in a number of medical indicators important for medicine. It is still very good, but now there are a lot of manufacturers of another type, in particular, cheap analogues on less quality Chinese raw materials. We have very carefully developed the formulation, only European components and raw materials are used, and therefore it can be, of course, slightly more expensive for the consumer. At first we worked on the domestic polymer, but it was something. Peter also produced Nizhny Novgorod. These are all polyacrylates of domestic production, but this is not the same. Then very quickly, when we became more creditworthy, we began to buy, of course, the main components already in Europe. Tried India, Asia, in particular, Taiwan – do not fit. We are very concerned about the quality of raw materials and the stability of this quality. And they, sometimes, are hooligans. Europe also supplies stably.

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