A unique module of clean rooms according to GMP standards was opened in the training center of the Kaluga pharmaceutical cluster
On September 2 in the building of a new academic building of the National Research Nuclear University MEPhI in Obninsk, the grand opening of the module cleanrooms of the Center for the practical training the employees in the pharmaceutical industry was held.
On September 2 in the building of a new academic building of the National Research Nuclear University MEPhI in Obninsk, the grand opening of the module cleanrooms of the Center for the practical training the employees in the pharmaceutical industry was held. The ceremony was attended by Kaluga region Governor Anatoly Artamonov, the rector of MEPhI Mihail Strihanov, members of the Kaluga Region Government, executives of pharmaceutical companies located in Kaluga region.
As part of the opening ceremony, agreements were signed on the transfer of equipments to the branch MEPhI from the SPI "Direction of Technopark" Obninsk and АO «Agency for innovation development – center for cluster development of Kaluga region» (AIRCO).
This project was created to address the issue of human resourcing companies – participants of the pilot innovative territorial cluster «Pharmaceutical, biotechnology and biomedicine» Kaluga region in 2015-2016 and is still the first and only similar project in Russia.
In 2015, the training and demonstration laboratories of the practical training center were equipped with a module of clean rooms for educational and research purposes. In the first stage of the project has been acquired and installed the module a clean room with a set of engineering equipment. The equipment is designed to provide the necessary conditions for the microclimate of clean rooms in terms of: temperature, humidity, dust and light in accordance with the class D purity in the framework of international standards GMP (Good Manufactured Practice). To ensure the appropriate class of cleanliness, the module is separated from the rest of the premises by hermetically sealed walls, ceilings and floors made from materials intended for finishing cleanrooms.
In 2016, the second phase of the project was implemented after which a test laboratory for clean rooms was created, equipped with a unique measuring and research equipment.
Anatoly Artamonov emphasized that the equipment of the center allows to carry out training specialists in conditions as close as possible to real production process. «The region has formed a good base for training. In the development of any industry, an integrated approach is essential based on human resources», commented Anatoly Artamonov.
In addition, the project will allow the integration of educational and scientific process, and also applied activities of students and specialists of the cluster enterprises, aimed at the creation of innovative pharmaceuticals, will provide the research laboratories in accordance with GMP requirements.
As Anatoly Sotnikov, General Director of AIRCO, said this project is important for the training of specialists in the pharmaceutical cluster. At the Centre for practical training of pharmaceutical industry employees will be annually trained more than 150 students of universities in the Kaluga region, as well as take courses to upgrade skills and retrain more than 50 employees of the cluster companies.
The project was financed from the federal budget subsidy granted to the budget of the Kaluga Region for the implementation of activities to develop the pilot innovation cluster "Pharmaceutics, Biotechnology and Biomedicine" in the Kaluga Region.
Additionally:
At present the Kaluga pharmaceutical cluster brings together 62 participants. Pharmaceutical companies of Kaluga region produce more than 109 kinds of products, about 20 in the process of registration, a few dozen in a promising development. More than 80% of the cluster production – finished pharmaceutical products, 19 billion rubles – the volume of output in 2015.
The Kaluga pharmaceutical cluster has a strategic goal to be among the three largest pharmaceutical clusters in Russia by market share. According to forecasts by 2020 this share will reach 10-12%.
According to the European Secretariat for Cluster Analysis (ESCA) results of the examination held in 2015 among 750 clusters, only 5 of Russian clusters received the bronze certificate of Excellence Cluster, among them — Kaluga pharmaceutical cluster. Kaluga pharmaceutical cluster was awarded the highest rating in the group Health and medical science. Assessment of performance were carried out in comparison with 19 leading European clusters appropriate profile.
