Procos Quality Control Laboratory in Isolator for HPAPI

A case study of Comecer Pharma solutions

PROCOS_NOVARA_isolators

Quality Control Laboratory in Isolator for HPAPI

Customer

PROCOS CBC Group, Italy

Customer Challenge

Build a multi-purpose HP API production facility with containment isolators for QC laboratory with  HPLC preparative, wet analysis, dry analysis, particle size and IR analysis processes in Isolator.

Performance Requirements

  • OEB 6 – 30 ng/m3 – 8h TWA
  • Internal ATEX ZONE 3G/3D IIB/IIC T3 (ZONE 2/22)
  • Instruments integration: analytical scale, magnetic and ultrasonic stirrer, coulometer, titration unit, wet digester with vent scrubber, IR spectrum and particle size analyzer

Solution Highlights

Comecer Engineering studied, designed and built 4 isolators with total instruments integration. Project duration: 6 months from study to installation, including 3 months for manufacturing.

  • Complete custom isolators design to fit all the laboratory processes
  • Push-Push filtration for high containment requirement
  • Double continuous liner for material in/out, installable as required for OEB6 products
  • Special integration for laboratory instruments, electrical connections, data connections, fluid connections with perfect containment fitting from outside to inside isolators

Location: Cameri

Category: Pharma

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