Rester

The Russian pharmaceutical company Rester Ltd is affiliated enterprise JSC IEMZ Kupol.

The plant is located in the Republic of Udmurtia, the advanced industrial region to the west from the Ural Mountains and in 1000 km from Moscow.

Activities

At this time Rester Ltd - the only plant in Russia which mastered a new form of production Solution of sodium of chloride of 0.9% 1000 ml with two ports of Luyer-Lok. Medication is intended for departments with the device "artificial kidney". These are the centers of a hemodialysis, resuscitation and intensive therapy.

Feature of this new product - sterile ports "Luyer-Lok" using which it is possible to connect quickly and reliably trunks of the device "artificial kidney" directly to a container, without use of a needle and anti-septic tanks. The new product is very convenient and reliable in use.

The polypropylene container provides complete tightness of a system, excepting hit in it of air, dust, bacteria. The biocompatibility of material - the most important condition of treatment of dialysis patients since the patient receives up to 150 procedures a year is important.

2017: New agreement on expansion of production with Fresenius

For Fresenius Medical Care company cooperation with Rester Ltd allowed to reduce logistic costs at supply of the dialysis clinics. For their 2018 in Russia already over 55 are also regularly created new. In Izhevsk also there was a dialysis center Fresenius Medical Care: it was discovered on November 28, 2017.

Power of the 1st queue of new section is 1,500,000 PD-sets on 2 liters a year. The exit to 100% design capacity was performed in 2017. So, need of expansion of production which was decided to perform along with mastering of more modern two-component solutions ripened. In November, 2017 in Izhevsk the new agreement of intent between Rester Ltd and Fresenius Medical Care is signed. The document contains specific dates and confirms desire of the parties to construct, equip and put into operation the new production body for production of two-component solutions and solutions in containers of large volume (5-10 liters) for connection of tsikler. The amount of expected investments is 20 million euros.

2008: Start of production of solutions for Fresenius

The grand opening of a new production line was held on April 2, 2008 and took place with the assistance of the Ambassador Extraordinary and Plenipotentiary of Germany in the Russian Federation Walter Juergen Schmida and official delegation of Embassy of Germany in Russia, the leaders of the republic and also the chief executive of Fresenius Medical Care Deutschland GmbH Emmanuel Gatti. Serial production of PD-solutions is from this point begun. There was a possibility of more widespread introduction of a method of peritoneal dialysis, providing Russians with world-class treatment.

2005: Agreement with Fresenius on production of infusion solutions

For the first time in the history of Russia the foreign pharmaceutical company - the German Fresenius Medical Care - entrusted the Russian plant to produce medicines under the brand.

One and a half years the world leader of pharmaceutics scrupulously studied work of the Izhevsk enterprise, previously having signed the agreement of intent.

Contract signature was preceded by deep audit of the Russian producers of sterile solutions by Fresenius company. Rester sustained check on compliance to requirements of rules of the European GMP, showed the high culture of production, and, above all, already had five years' experience of treatment of modern polymers by then – Propyflex film. The contract for coproduction of solutions for peritoneal dialysis between Rester and Fresenius Medical Care was signed in 2005. Special technology equipment which installation and a commissioning it was performed by the German company Pharmatec jointly with specialists of Rester Ltd under control of engineers and technologists of Fresenius company was purchased.

Performance of the new Restera line will allow to cover completely need of Russia for such solutions, spoke in the company. Products which are turned out by RESTER Ltd are not done at this time by any enterprise in Russia. The purchasing amounts of solutions guaranteed by the German partner for a period of 6 years are approved.

In RESTER Ltd product quality is traced on each production stage. Control is carried out on a set of indicators. Samples from each production lot remain for the subsequent possible analysis. But it, as a rule, is not required. Besides, the double system of gateways works at a factory, the microbiological analysis of washouts from walls, the equipment, technology clothes is systematically carried out. Strict control there undergoes raw materials, medicine solution, sterilization of finished goods, climatic providing "net" premises, packaging and marking of containers. For all the time of work of the enterprise there was no claim for product quality.

At this time Rester Ltd - the only plant in Russia which mastered a new form of production Solution of sodium of chloride of 0.9% 1000 ml with two ports of Luyer-Lok. Medication is intended for departments with the device "artificial kidney". These are the centers of a hemodialysis, resuscitation and intensive therapy.

2000: Creation of the enterprise

The pharmaceutical enterprise "Rester" was created in 2000. It was initially designed according to the European standards for production of infusion solutions using modern foreign equipment and technologies.

The plant reached design capacity in January, 2001.

Rester is producer of infusion solutions in containers from a laminated film on the basis of polypropylene, free from chlorine. Being engaged in production organization of infusion solutions, the company focuses on the international standards - the rules GMP, than and equipment selection, structure of a laboratory complex, materials for packaging, aseptic conditions of production was caused.

Creation of the Rester enterprise is our first step in development of the direction of the organization of new pharmaceutical productions. The purpose - creation of a number of the enterprises united in the Multimodular pharmaceutical center having modern advanced technologies, the developed infrastructure, a flexible management system, corresponding to both the Russian, and foreign standards and as result, production of the high-quality medicines demanded by the market.

The enterprise was designed from a zero cycle (green-field operation) by the Swedish company LUKI Engineering AB. Delivery and installation of a production equipment, acceptance and putting into operation and also validation of the enterprise are carried out by LUKI Engineering AB company with participation of the Czech company Lab&Pharma at technical support of the Russian state foreign trade association "Mashinoeksport" well-known in the world markets.

Observing modern quality requirements of medicines, material for packaging selects a laminated film on the basis of polypropylene (Propyflex of Sengewald company, Germany). The production process, the used technologies, the production and laboratory equipment, maintenance, maintenance of documentation and qualification of personnel completely conform to requirements of international standards including GMP of the EU.

Pharmaceutical production conforms to requirements of international standards and regulations of the European GMP standard (Good Manufacturing Practice)

Main links of technology process:

1. Preparation of production premises and equipment for work.

2. Receiving the water purified and waters for injections takes place step by step:

• removal of mechanical impurity and iron;
• softening using ion-exchange pitch;
• obratnoosmotichesky filtering;
• UF radiation;
• distillation.

Equipment of VATTENTEKNIK companies (Sweden)

Preparation of solution happens in reactors using the magnetic mixers excluding contact of solution with the external environment. All parameters are controlled by the built-in processors.

Equipment of GETINGE company (Sweden)

At production of packets the laminated film on the basis of polypropylene, free from PROPYFLEX chlorine of production of SENGEWALD company (Germany) is used.

Equipment of PLUMAT company (Germany)

For filtering of solutions filters with sizes of time of 1.0 microns and 0.22 microns of PALL company (France) set consistently are used.

Pouring and packing of solution is made using turbine dosers of production of PLUMATEX company (Germany).

Sterilization happens in an industrial sterilizer of type through passage at a temperature of 121 °C within 20 min. All cycle of sterilization lasts about 80 minutes.

Equipment of GETINGE company (Sweden)

Visual control on mechanical impurity and packaging of finished goods.

At the enterprise the quality control department consisting of a laboratory complex is provided:

• chemical analysis laboratory
• microbiological laboratory with the block of control of bacterial endotoxins.

The quality of raw materials and finished goods is checked according to the requirements regulated by the Russian pharmacopeia and the existing specifications and technical documentation.

Postadiyny control provides observation of process in all previously set critical points.

Except a QCD the department of quality assurance with structural divisions of group of validation, group of development and control of documentation, group of self-inspection functions. Besides as OOK carrying out training and advanced training of the working personnel enters.