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XI-I SERIES

Machine specially designed for sterile pharma filling,
able to fill sterile liquid and sterile powder,
Output up to 7.000 b/h

FEATURES

  • Filling, stoppering and crimping machine for vials and syringes.
  • Intermittent rotary filler for doses from 1ml to 500ml.
  • For formats up to 80 mm ø in simple configuration. Maximum output 4.000/ hour.
    For formats up to 26 mm ø in double configuration.  7.000/ hour. 
  • Totally built in stainless steel Aisi 304.
  • Built as per cGMP, FDA standards.
  • Machine can be sterilized by H2O2, and without corners.
  • Machine can hold up to 8 heads.
  • Elements in contact with product Aisi 316L
  • Compact machine including stopper introduction by means of a pick and place, capsule introduction, and Crimping head.
  • Controlled through axes controlling system.
  • Machine completely servo driven.
  • Nozzles ra<0,5 with special rugosity for injectable products.
  • Vials reject for no filled vials, no stopped vials, lower Lyo stoppered vials and no capsule vials.
  • No vial, no fill.
  • DQ documentation.
  • Vials Filling by means of: Peristaltic pump, Stainless steel Rotary pump, Ceramic Rotary pump, CIP/SIP Rotary pump.
  • High Containment solution.

ADDITIONALS

  • IQ, OQ Documentation.
  • CFR21 compliance.
  • 100% vials weighing.
  • Laminar Flow (LF).
  • oRABs, cRABs, Isolator.
  • Gas Flushing.
  • Airless movements, without any air consumption.

 

STERILE INJECTABLES