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