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Equipment Validation

Chicago Control's Equipment Validation Services Team utilizes their vast technical & regulatory knowledge & appropriate resources to quickly and reliably complete protocols that are thorough and aligned with your standards and are defendable. We pride ourselves in providing Equipment Validation Services for the following:

  • Purification skids
  • API or final product mixing tanks
  • API or final product refrigerators or freezers
  • Stability sample refrigerators, freezers, and incubators
  • Cell banking freezers
  • Filtration systems
  • Fermentors
  • Equipment steaming cycles
  • Autoclave load cycles
  • Environmental control systems including chambers/stability rooms & HVAC systems
  • Building Management Systems (BMS) such as Metasys
  • Clean rooms and temperature/humidity/differential pressure control systems
  • Plant utility systems including water-for-injection (WFI), deionized water (DI), steam systems, compressed air systems, alcohol systems, and nitrogen systems
  • Blenders, mixers, granulators, milling machines, dryers, drying rooms, metal detectors, emulsifier, steam kettles, pumps, fluid bed processors, weighing systems, tablet coating systems, tablet presses, and encapsulators
  • Temperature mapping of ovens/dryers, drying rooms, cool/cold storage rooms
  • Sterile/Biotech equipment/systems including lyophilizers, sterile/bioreactors, filter systems, filter integrity test systems, pressure/temperature controls
  • Bulk pharmaceutical manufacturing equipment trains including reactors, blenders, centrifuges, dryers, temperature controls, vacuum/pressure controls, dispensing controls & automated sequences
  • Packaging lines including bar code verification systems, bottle unscramblers, inspection machines, heat sealers, labelers, pouch dispenser, and shrink bundlers

Chicago Controls adheres to the industry standards below for its 100% quality deliverables.

  • Equipment Installation Qualification (IQ)
    • Equipment System Details, Components and Design Features
    • Instrumentation
    • Utilities (Inputs & Discharges)
    • Operating / Cleaning / Maintenance / Calibration programs
    • System drawings / Spare Parts List (Critical & Normal)

  • Equipment Operational Qualification (OQ) & Performance Qualification (PQ)
    • Range of design/operating parameters
    • Operating /Testing procedures & Sampling Plan
    • Equipment Utilization List
    • Product & Commodity Utilization List
    • Test Protocol