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About the company

Berezovsky pharmaceutical plant

Berezovsky pharmaceutical plant

The company starts out as a drug distribution business (OOO (LLC) AS Buro). In 2002 conditions are ripe for establishing a local pharmaceutical industry. New manufacturing plant was founded.

However namely the 1st of October 2007 the day when the first license was obtained is considered to be the official birthday of the company.

In 2015 it was decided to expand production and storage areas. At the moment a new more spacious building is being constructed on the territory of JSC Berezovsky pharmaceutical plant. The new building will be bigger than a current one: the total area of all rooms will be 4 511 square meters. It is planned to place several new warehouses there: for ready products, for quarantine storage, for storage of raw materials and for storage of packaging materials. Moreover it is planned to place a new high-speed automated packaging line, capable of packaging up to 16 million packages per year, the new modern microbiological laboratory and many other industrial areas.

Sketch of JSC Berezovsky pharmaceutical plant complex with advanced production and storage facilities.

Sketch of JSC «Berezovsky pharmaceutical plant complex with

advanced production and storage facilities.

Production

  • Nowadays the plant produces different pharmaceutical dosage forms:

  • – tablets

    – film coated tablets

    – hard gelatin capsules

    – solutions

    – powders and granules

    Productive capacity is nearly 50 million units of finished product. General area of the plant today is 2 thousand square meters. The clean area (class D) occupies 400 square meters.

    The right to manufacture medicinal products is confirmed by the License of the Ministry of industry and trade of the Russian Federation. In addition all the building space is designed and built in compliance with the requirements of GMP national standards.

    The success of any company depends on skills and experience of the personnel. Thats why Berezovsky pharmaceutical plant has employees with pharmaceutical education, scientific degree and many years of experience in production and quality control of medicine.

  • The plant is fitted with production equipment from worldwide leading companies:

  • 1. High Shear Mixer Granulator

    High Shear Mixer Granulator

    High Shear Mixer Granulator

    The mixer made by Diosna (Germany) is designed for dry powder mixing, wet powder mixing and granulation.

    2. Fluid Bed Dryer Granulator

    Fluid Bed Dryer Granulator

    Fluid Bed Dryer Granulator

    Diosna fluid bed dryer is designed to provide the drying and granulation processes. Filtered, heated air is supplied from below and distributed via a leading bed. The distribution plate and the bowls conical form ensure that the products movement is controlled.

    3. Powder mixer

    Powder mixer

    Powder mixer

    The mixer is intended for dry powder blending. Homogenous product blending is ensured through the container geometry and its three-dimensional motions.

    4. Tablet press

    Tablet press

    Tablet press

    IMA-Kilian rotary tablet press is designed to provide compressing powder/granules into tablets of uniform size and weight.

    5. Film coating machine

    Film coating machine

    Film coating machine

    The Diosna (Germany) vertical centrifugal coater is designed for film coating process – an application of coating composition to a moving bed of tablets with the concurrent use of heated air to facilitate evaporation of the solvent.

    Blister packaging machine

    Blister packaging machine

    Blister packaging machine

    The primary packaging process is aimed at ensuring that medicines arrive safely in the hands of the patients for whom they are prescribed. The Italian packaging machine by IMA is suitable for processing all types of packaging materials excluding the forming aluminium. The machine features compact design and balcony-type that makes it extremely accessible and easy to use.

    6. Tablet counting and filling machine

    Tablet counting and filling machine

    Tablet counting and filling machine

    The machine is suitable for the counting and filling of tablets, hard gelatin capsules and a wide range of other solid products.

    7. Automatic powder packaging machine

    Automatic powder packaging machine

    Automatic powder packaging machine

    It is designed to provide the following process steps – filling, sealing, slitting, printing, cutting and bag making.

    8. Reactor

    Reactor

    Reactor

    The reactor is suitable to provide solid and liquid components mixing processes. It meets the pharmaceutical industry's requirements for maximum purity and optimized heat and mass transfer combined with suitability for GMP use.

    9. Liquid filling machine

    Liquid filling machine

    Liquid filling machine

    This machine is made of qualitative stainless steel. It is suitable for filling liquid solutions into cylindrical vials.

    10. Automatic Cartoning Machine

    Automatic Cartoning Machine

    Automatic Cartoning Machine

    The machine can open cartons, insert the products and leaflets into cartons, emboss, tuck-in closures and automatically discharge cartons. The machine is equipped with a series of sensors and automatic protective devices to assure the machine runs safely and effectively. There were bought two cartoning machines made in South Korea.

    After all processes finished products are stored in stock under controlled conditions.

    The company constantly extend the scope of medical products. For example, in 2016 the enterprise got a new license for production solutions and powdery medicines as well as for gel packaging.

    Thus, Berezovsky pharmaceutical plant has the well-equipped production which allows the enterprise to produce tablets, capsules, solutions, powders and granules.

    All the rooms correspond to their functional appointments and placed in the building in a special way to avoid pollution of products.

    A necessary microclimate (temperature and humidity) is created in all clean areas by work of two industrial French air conditioners throughout the year. Each air conditioner works just 50% of its capacity. In the case that one of them would be broken other one will begin to work 100% of its capacity. The air in clean areas is purified from different microorganisms and aerosol particles by three-stage air filtration system.

    Air conditioner

    Air conditioner

  • An equally important role in maintaining the cleanliness and special conditions at the plant plays:

  • 1) Equipment for water purification by reverse osmosis

    Equipment for water purification by reverse osmosis

    Equipment for water purification by reverse osmosis

    2) Compressor

    Compressor

    Compressor

    Purified water and compressed air, necessary for technological purposes, go into the production area through the appropriate distribution system.

  • Pharmaceutical quality system

  • Pharmaceutical quality system at the plant is created, documented, maintained and corresponds to requirements of:

    The rules of the proper manufacturing practice, approved by order of the Ministry of industry and trade of the Russian Federation No. 916 from 14.06.13 (national GMP regulations)

    GOST standard (state standard) ISO 9001:2011 The quality management system. Requirements

    International standard MC ISO 9001:2008

  • Policy in the field of quality defines ways of working for all staff and is an integral part of the overall development strategy of the enterprise.

  • Quality system, including quality guideline, enterprises standards, standard operating procedures and notes about quality, was created and functioning today to guarantee execution of GMP requirements and rules of regulatory documentation.

    Analytical and microbiological laboratories of Quality control department execute the quality control of raw materials and ready products. Laboratories have up-to-date analytical equipment, measuring instruments and reagents.

    Analytical laboratory

    Analytical laboratory

    Analytical laboratory

    In the analytical laboratories a quality control of products is performed with physicochemical methods of analysis on accordance to regulatory requirements. This laboratory is equipped with modern analytical equipment of such leading world firms as Agilent Technologies, ERWEKA GmbH, Mettler Toledo, SARTORIUS.

    Microbiological laboratory

    Microbiological laboratory

    Microbiological laboratory

    Microbiology laboratory is licensed by the Federal service for supervision of consumer rights protection and human welfare for the activities associated with the use of microorganisms III-IV groups of pathogenicity, No. 66.01.35.001.000118. The laboratory conducts quality control on conformity to requirements of normative documents by the index “Microbiological purity”. Also the microbiological laboratory is equipped with highly-technological devices such as autoclaves, incubators, laminar flow cabinets, device for membrane filtration.

    JSC Berezovsky pharmaceutical plant invites to cooperation!

    The company is open to partnership in all spheres of work. We will be glad to consider any kinds of cooperation (about delivery of solid dosage forms in-bulk for subsequent packaging, work on contracts, cooperation in the framework of licensing agreements etc.) and we are also ready to answer all questions about our products!

    Likewise the enterprise is interested in cooperation (collaboration) with other companies for joint production and further promotion of new pharmaceutical products to Russian market.