APIs and categorization
APIs (acronym of “active principles ingredients”) are pharmaceutical active principles, in other words molecules used to heal living beings.
Such molecules could be used for human purpose or with veterinary scope; in the range of APIs we can find different categories:
APIs are manufactured by chemical synthesis starting from the base molecule, which is often originated from a biological process (fermentation). In order to transform the base molecule to API’s, there are many chemical reactions split on different steps where molecules, idle from a pharmaceutical point of view, are classified as intermediates.
API’s synthesis is realized through multiple single operations which could be listed as follow:
Active on this market in the last 40 years, 3V Tech has a huge experience as manufacturing company for single process equipment or packaged systems in reaction, filtration and vacuum drying.
Based on pH which drives reactions, material of construction of a reactor changes as per following indications:
3V Tech is capable to cover all above ranges and in some specific cases special solutions could be implemented (Duplex 2205 glass lined)
GMP (good manufacturing practice) describes design criteria for process equipment following needs of different APIs categories (intermediates, oral APIs, High Potent APIs, Sterile APIs).
For oral APIs and sterile APIs a sanitary design is required with high demanding design and construction concepts in order to achieve maximum level of cleanability. All surfaces in contact with the product must be free from crevices, cracks, bumps and overall roughness ratio shall be lower than precise parameters. A series of cleaning devices (normally called CIP: cleaning in place) must be implemented to ensure best cleanability such for example spray balls, spray rings, etc…
Cleanability criteria shall be applied also to external surface not in contact with the product (both for process equipment and on board installations as pneumatic, electrical) whereas zone of installation is a clean room and/or inside containment system (glove box)
In order to provide a whole and full solutions portfolio, 3V Tech is now specialized in the supply of turn-key systems in this industry, not only offering individual piece of equipment but as global player for the full installation including piping (process and service piping), electrical and instrumentation package, supporting structure, walking platform and access ladders.
Leveraging on strong competences in mechanical and process engineering, 3V Tech presents itself as an EPC provider for APIs production (all type of APIs). On top of that 3V Tech is able to support and help customers with auxiliary packages such as: