Getting equipment up and running and compliant

The Regulatory procedures for manufacturing healthcare and Medical Devices require that all manufacturing process are stringently tested and then validated to prove that they can repeatedly produce the product components to the required and pre-approved quality standards. All equipment must be kept in a state of validations at all times during production and BDL consulting have extensive experience in the transfer commissioning and qualification of most types of mechanical manufacturing equipment. Contact us for details.

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Validations (CQV)

  • Protocol Writing - VMP, URS, DQ, IQ, OQ, PQ
  • FAT, SAT and PQ execution / management
  • Protocol test data reporting, summaries & conclusions.
  • Product design reviews for acceptance criteria - dimensions, visuals , fit for function etc.
  • Equipment Builds - FAT
  • Equipment Transfers
  • Equipment Factory Installations
  • Equipment Commissioning - SAT / PQ
  • Injection Moulding Machines, mould tools & ancillary equipment
  • Assembly Machines
  • Inspection equipment
  • Gauge R&R
  • Lab testing Equipment

  • Astra Zeneca  Spray Nozzle MIcro Molding Equipmenr FAT validation trials in Germany
    Astra Zeneca Spray Nozzle MIcro Molding Equipment FAT validation trials in Germany
  • Astra Zeneca  Spray Nozzle MIcro Molding Equipment FAT validation trials in Germany
    Astra Zeneca Spray Nozzle MIcro Molding Equipment FAT validation trials in Germany
  • Astra Zeneca Spray Nozzle Assembly SAT validation Trials, Spain
    Astra Zeneca Spray Nozzle Assembly SAT validation Trials, Spain
  • Team discussing the Process for the Micro Moulding Machine, Germany
    Team discussing the Process for the Micro Moulding Machine, Germany
  • Cleanroom Mould Tool validations, Netherlands
    Cleanroom Mould Tool validations, Netherlands
  • Cleanroom Mould Tool validations, Netherlands
    Cleanroom Mould Tool validations, Netherlands