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Process Validation

Chicago Controls offers expert associates to contribute to your Process Validation needs from the early stages of product development through its maturity. We setup and monitor your company’s Process Validation programs. This could potentially save your company years in time to approve your product.

Below lists a highlight of our strength in the area of Process Validation:

  • Process Validation Master Plans
  • Critical Parameter selection and studies
  • Methods validation and QC support functions
  • Protocols and Reports
  • We support the studies that involve
    • Process Pool Hold Time/ Buffer Hold Studies
    • Product Specific Cleaning Validation
    • Final Filter/ Bulk Container Validation
    • Shipping Validation
    • Genetic Stability
    • DNA and Host-Cell Protein Removal
    • Clearance of Process Additives
    • Viral Clearance/Inactivation
    • Chromatography Cleaning, Storage & Reuse Studies
    • Membrane Cleaning, Storage & Reuse Studies

  • We offer validation for
    • Sterilization processes
    • Clean room ambient conditions
    • Aseptic filling processes
    • Sterile packaging sealing processes
    • Lyophilization process
    • Heat treating processes
    • Plating processes
    • Plastic injection molding processes

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

  • Complete description of the process , and identify subjective criteria used to evaluate the product
  • Statistical methods and tools for process validation
    • Control charts
    • Capability studies
    • Tolerance/ Effects analysis
    • Robust design methods
    • Failure modes
    • Sampling plans
    • Mistake proofing

  • Protocol development (IQ / OQ / PQ)
    • Determine what and how to verify/measure
    • Determine how many to verify/measure, i.e. statistical significance
    • Determine when to verify/measure
    • Define acceptance/rejection criteria &required documentation

  • Monitor and control
    • Changes in process and/or product & State of control
    • Use historical data in process validation