3V Tech has long term experience in
implementation of these standards, as well as of many others, in the
equipment and plants supplied to Pharmaceutical Industry
The pharmaceutical Industry has very strigent requirements regarding several different aspects of equipment and plants being installed.
Such demands cover from full traceability of all materials coming in contact with the product, certications of welders that have manufactured the vessels, tight surface finish of metal parts which contribute to achieve very high levels of clenability.
In some applications, particularly for injectable products, sterility of equipment becomes an issue, which needs to be addressed in terms of demonstrating the full drainability of the equipment and validating that all "cold spots" in the plant reach and maintain the required sterilization temperature for a given period of time.
Automation systems must also guarantee 100 / oo traceability of production history, which includes all data that may be critical to the quality of the final product and associating all commands and changes to a specific operator, through password protected interfaces.
This operational structure is described in the greatest detail in some industry standards such as cGMP (for design and manufacturing of equipment) and cGAMP (for design and manufacturing of automated systems).