V-PHP cycle validation, equipment installation, protocols execution.
In compliance with regulations.
The stringent regulations in some industries, especially in the pharma, require that before each instrument can be inserted in the production process, it has to be correctly installed and tested in compliance with the specifications declared by the manufacturer and proved to be suitable for the use for which it is intended.
Our qualified team is here to support you with the installation of Bioreset vaporized hydrogen peroxide generators and the validation of the V-PHP cycles, in compliance with the regulations and specifications in use in each sector.
Specifically for the pharmaceutical sector, we deal with the execution of the IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) protocols to prove the adequacy of the instrument to the customer’s specifications (URS – User Requirements Specifications), according to the GMP (Good Manufacturing Practice) and GAMP 4 (Good Automated Manufacturing Practice) guidelines.
At the end of the installation and qualification operations, thanks to targeted and specific training, we can support you for daily use and routine maintenance of the equipment.