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GMP Execution

BIAZZI delivers full GMP hydrogenation plants, incl. control system acc. to GAMP and 21 CFR part 11.

Reactor GMP particularities:

  • Easy cleaning for all internal parts
  • Reactor polished Ra < 0.0008 mm or less
  • Easy inspection for all internal parts
  • Built-in cleaning nozzles
  • Self draining execution
  • No product dead space
  • No cross contamination
  • Fulfilling FDA requirement

BIAZZI offers:

  • FAT (factory acceptance tests)
  • IQ (installation qualification)
  • OQ (operation qualification)

BIAZZI collaborates for:

  • PQ (process qualification)