An article for the magazine "Chistye pomeshcheniya" ¹58
Specialists of «UNICA engineering» have prepared the text for the publication based on the article Hilary Ashford published in January 2016 (www.cleanroomtechnology.com).
Making traditional large clean rooms includes relatively significant investments of time and money. Hence, there appears more and more alternative solutions, for example, disposable systems, modified isolators, glove boxes and RABS - Restricted Access Barriers Systems.
Nowadays, several factors stimulate developing of insulation technologies:
1) Increase in production of biologically active agents;
2) Development of more effective and potentially more active drugs;
3) Scientific committees and institutions stricter requirements.
There are different ways of corresponding those requirements. Camfil Air Pollution Control company started a project of 4 sectional pulse dust collector, that can be installed inside the facility and excludes often and expensive filter changing. Moreover, “bag in bag” system makes the process as safe as possible. One more example, German company Fette Compacting made it possible to upgrade the installed standard equipment in the future. When applied to the tablet press FE55 it enabled working with toxic and active substances with the dust concentration of 10 to 100 mg / m3.
HepaSafe technology makes it possible to change the filter without turning off the ventilation installation. Apart from that, FlowSmooth company technology provides laminar airflow through the obstacles excluding turbulence. Airsafe automatic safety controller monitors and controls the airflow rate, getting accurate data, independent of turbulence and vibration. This technology is completely self-contained and self-monitoring that eliminates the need for additional filter housings, air ducts, air sampling points on filters and other heavy parts. ESCO Pharma Company developed a barrier isolator which to be used as the pharmaceutical biological safety boxes 3 and class 4 for mixing ingredients as well as for sterility testing of small series, total disinfection efficiency rate increases by 600%.
Flosokawa Micron Company used the latest computer technologies for simulating airflow aerodynamics to create customized programs that ensure reliable protection of the workplace from the potentially hazardous dust emission and fumes. Extract Technology has also used the simulation of airflow to create innovative isolator system designed to work in a sterile environment with specific requirements for control of temperature and humidity. Manchester Medical Art Technology (MAT) has also made a great contribution into developing of insulation technologies.
As a result, we can see the increase in production of active substances and both renovation of operating plants and opening new ones. For example, Fareva, GEA, Johnson Matthew, Vetter and others made significant investments into insulation technologies. Without any doubt, all these measures will make the production safer and, at the same time, increase the quality of the products.