Clean rooms

The company "PharmTechnologis" develops projects of "clean rooms" for the pharmaceutical industry, corresponding to generally accepted Russian and international standards. We are always looking for the optimal solution in the selection of equipment and materials and the development of the project both in terms of price/quality, and taking into account the requirements for the room, production technology, planning solutions, ventilation system and air conditioning.

When preparing the project, we pay special attention to the collection of initial data and its careful analysis, together with the design task, in order to minimize errors in the project implementation and, consequently, reduce the costs of the customer.

When carrying out assembly and construction works, constructive elements of a number of European and domestic manufacturers are used, with which the company Pharm Technologis has partner relations.

In addition, certified testing laboratory a any stage of works (constructed, quipped, operated production) can efficiently estimate the results of performed operations, perform certification of clean areas and equipment for clean rooms.

Clean rooms in the pharmaceuticals industry play pivotal role: it is impossible to organize in a qualitative manner the drug production without them.

They represent barrier rooms which prevent to penetration of particles-contaminants: dust, dirty, chemical vapors, and aerosol particles. Within the rooms it is maintained desired micro-climate with required quantity of particles per one cubic meter. Clean rooms sometimes are installed in already-existing buildings.

Clean rooms at the enterprise contain four main zones (conditionally A, B, C, and C).

Zone A corresponds to cleanness grade 5 ISO and is intended for operation performing in aseptic conditions. Laminar air flow is present in the area of such type.

Zone B immediately follows zone A and is used for aseptic production of drugs. It is equipped in accordance with grades 5 and 7 ISO.

Zones C and D are applied for less serious operations. Zone C corresponds to grades 7 and 8 ISO and zone D to grade 8 ISO.

At the design stage, manufacture and mounting A clean room is equipped with engineering system elements already being adopted for aseptic conditions. This elements consist of:

- pass-through windows and air locks;

- systems for air intake, preparation and distribution (inlet, outlet and recycle vent units, conditioners, air intake apparatus, air distributors with finish filters, air regulating devices, elements of automatic equipment, etc);

- additional filter-ventilator modules for formation of especially pure zones within clean rooms;

- sanitary technical complexes;

- light illumination;

- phone communication;

- fire and security alarm;

- control device for zone access;

- control systems for engineering systems of clean rooms;

- informational board.

Exact equipment composition is defined by the project.

Complexes includes base fencing elements providing reliable air-tightness. Structures of all filter elements: wall panels, ceilings, floors are performed as plane surfaces without sharp projections and level differences. It is necessary to perform a sealing of all element joints. Passages between walls, ceiling and floor have no sharp corner that is performed as rounded. Fencing elements have smooth surface not evolving injurious substances, stable for reagents, disinfectants and UV-irradiation. All internal fencing structures are easy accessible for washing and disinfection.

Wall and ceiling fencing are performed most often from sandwich panels. Floors are performed from special material with anti-static properties, stable to mechanical damages and effect of disinfectants. Floor may be self-leveling or welded. Sometimes, for floor it is used pore linoleum.

In the room, where drugs are manufactured, it is necessary to provide not only clean air but particular pressure differences. For this purpose there is used the system of air distribution and finish purification, independent system of purification of supplied air, and vent system.

Operation of complex engineering system is controlled by joint control system which can be integrated into the common control chain. It consists of the control system, management by input-out systems and local monitoring system for internal air purification.

In order to permanently control he concentration of particles in air in the clean room there are installed the special counters.

For detail information you may communicate by telephone +7(812)385-30-30 or by e-mail info@pharmaspb.com