In Orbita Ingenieria we provide the supply and installation of purified water (PW), water for injection (WFI) and pure steam generation systems, as well as their associated storage and distribution systems – PW, WFI loops and pure steam networks – and clean and sterile compressed air systems.
Pharmaceutical water and clean/sterile compressed air must be generated guaranteeing the required parameters, but in addition these parameters must be preserved, until the fluid is finally consumed in the equipment supplied or points of consumption.
Our technicians have the experience of multiple water systems for pharmaceutical use, nationally and internationally, successfully audited for drug production in accordance with the USP, EU Ph. regulations and for markets regulated by other regulations (China, etc.).
1. PW, WFI & pure Steam (no se traduce)
Waters for pharmaceutical use are those that have been treated to obtain microbiological and physicochemical characteristics, which meet the application standards. Waters for pharmaceutical use or Compendial Waters are considered to be:
- “PW” Purified Water
- Injectable water quality “WFI”
- Pure steam.
The principle of generating these waters must comply with the technical requirements accepted by the applicable legislation. In the case of pharmaceutical forms manufacture, the difficulty of continuously maintaining within parameters the supply of these waters at the points of use, in some cases the design of the generation, storage and distribution assembly does not offer sufficient guarantees and therefore it is necessary to have a supplier as Orbita Ingenieria capable of offering integrated designs, which guarantee a reliable and robust operation of water systems for pharmaceutical use.
2. Compressed Air – Clean/Sterile (no se traduce)
Air in contact with pharmaceutical products is considered as a product in itself. The compressed air supply required in pharmaceutical applications where this gas comes into contact with the product must meet high requirements for impurities and microbiological content. To meet these requirements, the generation equipment must be selected and the facilities must be designed to supply clean compressed air, or sterile compressed air.
Orbita Ingenieria is able to design integrated generation, filtration and distribution solutions for continuous supply of gases in contact with pharmaceutical products according to the needs of each customer.