API MANUFACTURING FACILITY (5000 KG/Y)
REATORG performed design, supply of equipment, installation and commissioning for three production sites of purification, drying and packaging of APIs for the Russian pharmaceutical company "NATIVA".
The facility is placed on the 5th floor of a building. It consists of three production sites:
• The first site is to produce hormonal APIs.
• The second site is to produce cytotoxic APIs.
• The third site is to produce non-toxic APIs.
There were several major tasks during implementation of this project:
• Place equipment in limited space.
• Ensure staff protection from the exposure to manufactured APIs.
• Ensure that manufactured APIs are not in contact with stainless steel during hot filtration stage (for first and second production sites).
• Ensure a gravity flow of slurry to a filter dryer or centrifuge.
• Place circulation thermostats, control boxes and other equipment with protection level lower IP54 in a technical area.
To solve these tasks REATORG LLC completed the following works:
1. Made a BIM-model of the future facility and detailed design documentation for each production site and utilities (purified water, clean nitrogen, compressed air, vacuum, hot and cold silica oil, breathing, feed lines and etc.).
2. Designed, manufactured and supplied their own process equipment under trademark REATORG TECHNOLOGIESTM (reactor systems based on glass and glass-lined vessels for dissolving, filtration and crystallization of APIs, systems for storage and distribution of PW).
3. Selection, adaptation and supply of technological equipment of foreign suppliers (filter dryers, vacuum drying oven, negative pressure isolator, horizontal filtering centrifuges, titanium reactors, thermostats, vacuum conical dryer, CIP-station, split-valves, etc.).
4. Solutions for staff protection from the exposure of produced APIs.
5. Installation of process pipelines, including clean media pipelines (purified water, nitrogen).
6. Installation and piping of technological equipment.
7. Commissioning.
8. Equipment qualification (for several units).
For more information about this project, see the section "COMPLETED PROJECTS" section.
