GMP Execution

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BIAZZI delivers full GMP hydrogenation plants, including control systems according to GAMP and 21 CFR part 11.

GMP execution means an appropriate design of the plant and its critical equipment, in particular with the focus on

Clean in place (CIP) design, easy cleaning of all internal parts

Process equipment inside polished Ra < 0.8 Ám

Sharp edges rounded

Optimised design of agitators (shaft, impeller, turbine)

Inspection accesses to process equipment

Built-in cleaning nozzles

Self draining execution

No product dead space

Compliance to GAMP5 for complete SCADA

 

BIAZZI offers:

FAT (factory acceptance tests)

IQ (installation qualification)

OQ (operation qualification)

 

BIAZZI collaborates for:

PQ (Performance qualification)