FDS (Specificazioni Funziunali di Design)

Specification in which the demands of the buyer are transferred into a technical solution (from the manufacturer’s point of view)
Issued by: Manufacturer

DESIGN SPECIFICATION (DS)

Specification of the technical basis and specification of the limiting factors that are to be considered during development, construction and assembly. DS ensures that all customer requirements and current valid standards from CGMP, EU, EN ISO and the FDA are satisfied.

FAT / SAT (Factory Acceptance Test /Site Acceptance Test)

Documented acceptance tests at the supplier/customer with test log, test summary, list of open issues, and release certificates.
In BOCON, before the sale, the factory provides customers with the design and consultation on the overall equipment and facilities of the ETO workshop and assists in the formulation of the overall planning and layout of the ETO workshop. According to the characteristics of the customer site and product, material, packaging, transportation, and future development, we choose the material, configuration, control mode, volume, and quantity for the sterilizer. To assist in the preparation of the ethylene oxide sterilization process, verification scheme, ETO workshop management rules and regulations, equipment use and maintenance, etc. At the same time to provides relevant standards, preheating, residual analysis, processing technology consultation, and cooperation.

DQ, IQ, OQ, PQ

DQ (qualificazione di design)
IQ (qualificazione d'installazione)
OQ (qualificazione operativa)
PQ (qualificazione di prestazione)
Da e specificazioni di u produttu è di i requisiti, à l'analisi di risichi, à a pianificazione è a esecuzione di i passi di qualificazione individuali, ci occupemu di tuttu ciò chì l'implementazione richiede.

Validazione: BOCON furnisce a validazione di u software. IQ, rapportu OQ, è supportu di PQ dopu a stallazione.