Innovations for a Healthy Life.

Introduction

With its operating pharmaceutical plant pharmaceutical located in Novoorlovskaya site (Special Economic Zone Saint Petersburg), WERTEKS is one of the largest fast-growing domestic pharmaceutical producers in Russia. In 2015 the Company has inaugurated the first stage of the Innovation and Production Complex and the start of remedies production. A total area of about 21,000 m² built in just two years, working 24/7 operations. Since 2018 the Company has implemented projects of the second and third stages of the facility. In 2019 the laboratory and warehouse block, with a total area of around 7,300 m² (the second stage), started its operation. At the end of the same year, WERTEKS fully put the pharmaceutical complex with a total area 56,500 m², taking into consideration the third stage with an area of more than 28,000 m² into operation. Creating of new facilities required additional equipment for production sites. Today in WERTEKS’ portfolio there are more than 300 items, including original combined preparations to be applied in dermatology, gynecology, cardiology and otolaryngology. These numbers are destined to increase, considering that more than 100 remedy items are currently under development and registration.  «In our portfolio there are preparations with original compositions and generics for a wide area of use, cosmetic products and vitamin complexes». Not surprisingly, the Company’s mission is summarized  in the motto Innovations for a Healthy Life. «We care about improving the quality of life and strengthening the health of millions of people, by producing effective, safe, quality and affordable products». To pursue this mission, WERTEKS chose IMA Active technologies for the extension of their Innovation and Production Complex in Saint Petersburg.

Which is the vision behind the extension of your facility?

Pursuing national interests, our foremost goal is to provide the population with affordable, high quality and effective medicines in order to improve the quality of people’s life. Upon that, the need for such medicines is steadily growing and we are trying to meet these demands of the society and the market by ramping up the production.
We are also constantly increasing investments into R&D and launching several new and highly sought products. All these goals have required the extension of our Innovation and Production Complex.

Your Company has a long experience with IMA Active fluid bed processors. Which three main criteria do you appreciate the most?

1. Reliability
2. Manufacturability
3. Practicality

For the new area of your facility, you also chose IMA Active coating pan. What were your require-ments for this technology? What was your main reason for choosing Perfima?

We certainly based our choice on the operational experience we already had with Perfima 200 at  the time. We also had the chance to compare the Critical Quality Attributes of tablets coated on Perfima 200 and on a similar equipment by another manufacturer we used before being partnered with IMA. Dry figures of production statistics allowed us not to have doubts about the choice of a new Perfima for its wide range of working parameters and full reliability.

How was the collaboration with IMA?

Integrity, professional competence and advertence: these the first three words that come to mind when thinking about our partnership with IMA Active. It is impossible to avoid some criticalities when dealing with new products. However, there was no day in which we were left alone and were worried about the final result while working with IMA.

Any future projects?

Of course, we have long-term plans. But any kind of the long-term plan consists of tactical intermediate goals. The current situation in the world and in Russia corrects them, but tasks for the development of the company scheduled for the future remain without any changes. In the long run, we intend to upgrade the existing and open new workshops for manufacturing of cosmetic products to significantly expand the area of hormonal medicines and to increase the capacity for production of the current portfolio of drugs. IMA can certainly take part in all these projects under healthy competition with other producers.

Case study: manufacturing optimization in a granulation line at WERTEKS.

The main goal was to optimize the granulation process to increase the productivity of a granulated material suitable to be compressed into tablets. More in details, the scope of the study was:

1. Adjust the process parameters during the wet granulation in Roto Mix 600 (HSMG).
2. Select the optimal process parameters for the IMA fluid bed dryer (FBD) in order to avoid an intermediate sieving and additional spraying to get the target on the granules specified final moisture range.
3. Only three components were included in the formula: Metformin hydrochloride (API), povidone K- 30 (binder) and magnesium stearate (lubricant).

The selected batch size was around 200 kg and the required ranges for granules final moisture content  (LOD) and bulk density were exactly 1.70-2.00 % and 0.55-0.65 g/ml respectively. During the optimization batches in collaboration with IMA technological support, the binder solution was changed in terms of viscosity (part of additional water was used to prepare the solution by decreasing the binder concentration to less than 40% w/w). In that mode the binder solution became suitable to be pumped with a peristaltic pump, avoiding the risk of exposure to the API when opening the lid for pouring. The viscosity was furtherly reduced by increasing the solution temperature allowing a significant reduction of the addition time. The decision to add the entire amount of liquid in one step only produced coarser and denser granules, with a reduced wet massing time. This helped in avoiding the final bowl scraping at the end of the product discharge since the phenomenon of product adhering on the internal side walls was successfully solved. Finally, the benefits obtained reflected in the reduction of the number of washing cycles between the batches of the same campaign. On the fluid bed, small changes (optimization of the air inlet temperature since the beginning of the product transfer and reduction of the air inlet quantity) led to a more reproducible drying end-point based on product temperature and/or phase time, matching the final target on the final granules moisture content.
In conclusion, the requested moisture content and bulk density range was reached for all the batches optimized and the manufacturing procedure for granule manufacturing was changed. The productivity was enhanced and the intermediate steps of dry milling and additional spraying were not any more required to keep the tablets in the specifications.