Designed according to GMP standards, the laboratory where the products from Oligarch Range are prepared is equipped with 3 types of state-of-the-art filters.
The air conditioning and air purification installations, part of the implemented production process, comply with all quality standards for the “Clean Room” environment.
The advanced air conditioning and purification system is implemented according to domestic and international standards (ISO 14 644-1/2015) imposed for this type of special purpose. We will let you know further information about the process of air filtration. Thus the air taken from the external environment is treated in proportion of 100% at the level of the air treatment plant and is subsequently distributed through 3 filtration stages:
Coarse M5 (conf. EN 779/2012)
Fina F9 (conf. EN 779/2012)
HEPA H14 (High Efficiency Particulate Air) – with a filtration efficiency of 99.9995 µm at a particular size of 0.3µm, with a penetration level <0.01%.
The advanced air conditioning and air purification facilities that the laboratory has are supplied by prestigious manufacturers: France Air (France), Plasteurope-Clean Room (France), PBC (United Kingdom), ALP (Italy), Emerson (USA / EU), Luve (Germany). Thus the clean environment we have contributes decisively to the quality of manufactured products, as we wanted to obtain the best quality just for you.
In addition, only highly purified RO-CEDI water is used in the production process. The capacity of the installation is 300 l / h WFI permeate at 0.03 µS / cm, purified water flow in recirculation system of 7500 l / h, recirculation speed of 3m / s, purified water conductivity 0.7 µS / cm, TOC 2 ppb , consisting of:
- stainless steel mirror water storage tank gloss mirror inside (1000 l), external coil for cooling and maintaining constant temperature, thermally insulated, with a safety valve type disc rupture – / + 2 bar and sterile breath filter;
- 10-point recirculation loop (in the production room in „the Clean Room”) with aseptic T-valves, WFI distribution pump, UV irradiation unit and monitoring sensors for flow / speed, pressure, temperature and conductivity of purified water;
- automation and parameter monitoring panel for the entire purified water production, storage and distribution system, with original software, validated in accordance with CFR21 standards, part 11. generps control panel, 15 ”touch screen type (HMI).