PATRICA ON-SITE GMP INSPECTIONS LIST

patrica on-site gmp inspections list

PATRICA SITE PRODUCTION AREA

patrica site production area

  • Three floors, 2400 m² total.
  • Reinforced concrete structure, glazed steel windows/doors.
  • Ground floor: finished APIs isolation with dedicated HVAC (ISO8).
  • Various reactors (2000-9000 liters), automated centrifuges, ultrafilters, ion exchange columns, gas and radical reactions.

  • Three floors, 1080 m² total.
  • Concrete structure, steel concrete floors (first and second floors), corrosion-proof tiles (ground floor).
  • Ground floor: Mesalazine isolation with automatic centrifuge (ISO8).
  • Similar machines as RS1, plus medium-scale hydrogenations.

  • Three floors, 1900 m² total.
  • Three sub-sections: hydrogenation area, controlled environment for Enoxaparin and peptides production.
  • Purification equipment: automatic centrifuge, ultrafilters, reverse osmosis, ion exchange, HPDC columns.
  • Environmentally controlled equipment: filter dryer with glove box, two lyophilizers (one with glove box).
  • Large-scale hydrogenations and ancillary filtering for pyrophoric catalyst.

  • Dedicated building, 1330 m².
  • Revamped in 2023 with AIFA approval.
  • 19 product working rooms, 8 dryers (various types), finishing equipment (mills, micronizer with 500 Kg/day capacity).

  • Small batch production (10-20 Kg) under GMP conditions for oral and injectable APIs.
  • Two sub-sections: 80 m² synthesis section, controlled environment section for drying and finishing injectable APIs (upgraded in 2013).
  • Equipped with small-scale hydrogenator and autoclave for pressured reactions.

34 glass lined reactor with a volume ranging from a minimum of 800 to a maximum of 7000 litres.

44 stainless steel reactor with a volume ranging from a minimum of 800 to a maximum of 13000 litres.

3 high pressure/temperature carboxylation reactors:

  • Vessel volume 3000 l
  • Working temperature 300°C
  • Working pressure 50 bar

2 hydrogenation reactors:

  • Vessel volume 600 and 5030 l respectively
  • Working temperature 200°C
  • Working pressure 30 bar and 35 bar respectively

Utrafiltration equipment (ceramic & polymeric membranes)

Nutche & Sparkler filters

Gravity chromatography column - HPLC column - IEX column

Stainless steel and Hastelloy Centrifuges (vertical & horizontal bag inverting)

installed capacity

installed capacity

2 freeze dryer equipment

Serail Lyo - Working Temperature: -60 / +50 °C - Shelves: 11 for 150 sqm of loading surface – Condenser: -50°C – Water Solution Based. Criofarma Lyo - Working Temp: -50 / +70 °C - Shelves: 8 for 108 sqm of loading surface – Condenser -50°C Water Solution Based.

Rotary biconical dryers

Delumper and Hammer mills (Danioni, Cosmec and Fitzmill)

Micronization

installed capacity
installed capacity
installed capacity