Clean rooms in the pharmaceutical industry

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RUSNANOCLIMATE - one of the leading contractors in the national market creation and reconstruction clean rooms, ventilation systems, heating, air conditioning and automatic.

In the design and construction of clean rooms in the pharmaceutical industry RUSNANOСLIMATE uses international experience establishing and operating pharmaceutical facilities.

On the projects in the pharmaceutical cleanrooms works professional engineers from Russia and Germany, with experience over 10 years.

In the pharmaceutical clean room is one of the factors that ensure the implementation of principle of GMP: «There is no process is the final stage of production or quality control of finished product can not be regarded as the only means to ensure sterility and other indicators of quality. Quality is laid production technology and organization, including clean technology environments".

Clean rooms provide pharmaceutical purity of the product, its protection of the environment, by mixing different kinds of products.

For vaccines, injections, ointments and certain types of solid forms is required to ensure sterility of the premises, aseptic manufacturing.

The quality of the final pharmaceutical products largely depends on the purity of the process media. The main sources of microcontaminants in the production of medicines are air entering the premises, equipment, personnel, raw materials and auxiliary materials.

RUSNANOCLIMATE offers integrated solutions for design and construction of clean room for pharmaceutical production in accordance with international GMP.

RUSNANOCLIMATS Engineers have experience in building clean rooms for companies in Europe and Russia. In the pharmaceutical GMP clean rooms play an important role in influencing the quality of the finished products of the enterprise.

Clean rooms in the pharmaceutical industry of European countries, USA, Japan and South Korea are essential to ensure high quality end product.

In Russia, the pharmaceutical companies must follow the standards of the Russian Federation GOST R 52249-2004, identical to "Rules of the production of pharmaceuticals EU".

RUSNANOCLIMATE in their projects (from design to implementation) ensures cleanliness of equipment and working environment by pharmaceutical companies in accordance with the rules of GMP, the defining characteristics of each stage of production - from the control source of raw materials until the delivery of the final product to the consumer.

GMP regulates the basic requirements for clean air in the manufacture of sterile medicinal products, equipped and operated by the state. For the production of sterile drugs (intravenous, intravenous fluids, eye drops, creams, ointments, emulsions, applied to the sterile areas of the mucous membranes or open wounds and damaged skin) are four types of zones.

• Type A (ISO Class 5): The local zone for operations with high risk, such as band filling, closing, opening the ampoules, the implementation of the compounds under aseptic conditions. 

• Type B (ISO Class 5): For aseptic preparation and filling - the space surrounding the area of type A. 

• Types C and D (class ISO 7 and ISO 8) clean areas for less critical stages of the production of sterile products.

Clean rooms used in the production of non-sterile products in order to protect them from microorganisms and ensure a long shelf life products.

In the manufacture of solid dosage forms using a zone class D (ISO Class 8, equipped), and in the production of non-sterile liquid medication - Zone C (class 7 ISO).

For liquid medications need a higher purity, as water is a favorable breeding ground for microorganisms. Due to the purity of the air space increases the shelf life of the drug.

With our knowledge and experience, well-functioning system of projects on time, organized logistics management system in the building, customers have the opportunity to save their resources. There is no need for continuous monitoring of the contractor (or, as often happens in Russia, redoing work after an inexperienced contractor made ​​an error in design or construction of clean rooms).

All RUSNANOCLIMATE customers receive regular reports on the progress of the design and construction works, which include photo and video reports from construction sites, the data on the supply of equipment that allows customers to be aware of the facility by 100%.

RUSNANOCLIMATE always delivers to the customer clean room in accordance with the approved technical requirements that meet all current Russian standards and regulations.

There are many cases where customers are turning to us to provide terms of reference of missed data, incorrect calculations - in such cases, RUSNANOCLIMATE engineers candidly point out errors and suggest on the basis of their experience to improve mechanisms for the parameters of the future complex of clean rooms, reducing the costs for construction, which can always be achieved through cooperation with many manufacturers' products in Europe and Russia.