Room, in which aerosol particle number is controlled which is built and used to minimize penetration, generation and accumulation of particles inside in which other parameters are controlled (pressure, temperature, humidity) by necessity. (W. Whyte, Cleanroom technology)
Cleanliness classes in pharmaceutical industry are A, B, C, D (GOST R 52249-2004 app. 1).
A zone is designed for operations with the high risk for quality of product (for example zones of filling, packing, opening of ampoules and bottles, connection of machine parts in aseptic conditions). As a rule laminar airflow is used in such zones, providing similar air velocity 0,36-0,54 m/s.
Keeping up laminar airflow must be confirmed by attestation (validation). Laminar air flow with lesser velocity may be used in isolators and transport boxes;
B zone immediately enlaces A zone and is designed for aseptic preparation and filling;
C and D zones are designed for less critical production procedures.
On the basis of designed project FAVEA engineering s r.o. company realizes integration, delivery and installation of all class cleanrooms.
Cleanroom systems, delivering by FAVEA company, include:
Wall panels
Doors and jambs
Airlocks
Floors
Lights
Filters
Air diffusers
Special equipment
Another facilities:
conditioning systems,
multilevel refrigerators for technological machinery and conditioning systems,
systems of production of purified water, water for injections, pure steam,
systems CIP (cleaning in place) and SIP (sterilization in place),
special-purpose stainless steel furniture for high-tech production (individual order is possible)
equipment and support systems for cleanrooms, including:
- Conditioning and ventilation - Heat and cold supply - Electricity and automatics, and also engineering systems: - water supply and canalization - low current gas supply
This year “Platinum Ounce” award in the special category of the organizing committee for the “Successful implementation of projects on modernization of pharmaceutical production in Russian Federation in accordance with the standards GMP” received company FAVEA
The worldwide most important document in determining the requirements for production and quality control of medicines for humans and animals is "Good Manufacturing Practice for Medicinal Products (GMP)".
Validation
In the methodological guidance we take into account the most recent issues of the national normative documents, the recommendations of the World Health Organization (WHO) and the Convention on mutual recognition of inspections in ...
GMP Training
The purpose of this training is to deepen the fundamental knowledge and expertise on the development of modern pharmaceuticals, manufacturing and quality control. Important objective is to train the personnel, ...
