Certification of clean rooms

As the main characteristic of the clean room according to terminology of GOST P ISO 14644 is concentration of the particles weighed in air, prior to operation of the new clean room, after repair and periodically in use it is necessary to carry out tests of the "clean" room to receive confirmation of that the room conforms to the set requirements.

The certified laboratory of the BERVER company has in the staff of highly qualified specialists, is equipped with the necessary devices of world famous producers having certificates of conformity of GOST P and brought in the State register of measuring instruments.

We offer the clients a complex of services in certification and validation of "clean" rooms according to requirements of normative documents (standards of the state standard specification P ISO series 14644, GOST 52539-2006, GOST P 52249-2009, etc.).

During carrying out certification of clean rooms check of the following parameters is carried out:
• Concentration of the weighed particles in the air environment (range of measurements 0,1; 0,3; 0,5 microns, etc.;
• Speed of a stream of air at the exit of filters, in air ducts
• Consumption of air and frequency rate of air exchange
• Pressure difference in clean rooms
• Check of efficiency of the installed filters of the last step of cleaning;
• Temperature and relative humidity in rooms
• Illumination level in rooms

Because in use extent of air pollution shouldn't exceed the set limits, normative documents defined frequency of carrying out tests of clean rooms. As a rule, together with the client the schedule of carrying out planned inspections is formed. The minimum list of works includes check of concentration of particles in air, temperature and moist parameters of air, integrity of filters. In case of carrying out the repair work connected with system of preparation of sterile air, the equipment, being in a clean zone, replacement of filters without fail it is necessary to carry out unscheduled inspection inspection.

By results of the carried-out tests to the customer the conclusion about compliance of the "clean" room to the established norms is issued. In case of identification of deviations of the actual indicators from standard values experts will define the reasons and will prepare recommendations about their elimination.

Our company is adjusted on long-term cooperation with clients: for minimization of expenses we not only offer optimum schedules of carrying out tests depending on purpose of rooms, but also we apply flexible system of discounts.

Besides services in certification of clean rooms we offer a complex of works on validation of productions (IQ/PQ) according to GMP EC requirements (the European standard of a good manufacturing practice), GOST P 52249-2009, GOST P ISO 14644-2002 and AAALAC.