We provide support for the validation of your production

IQ/OQ

The machine qualification carried out by Bausch + Ströbel provides a complete, reproducible and documented proof that the machine has been manufactured according to the purchase order, the design documents and the valid specification. It is conducted pursuant to the EU-GMP guidelines (Good Manufacturing Practice) and the PIC (Pharmaceutical Inspections Convention) recommendations for validation.

Machine validation includes

Installation qualification (IQ)

Installation qualification is the testing and the documented certification that the criteria for correct machine construction are fulfilled as defined in the test schedule. The following steps can be included in the test schedule:

  • Fulfillment of the customer order specifications
  • Installation and identification of mechanical components
  • Installation and identification of electrical components
  • Installation and identification of the machine control (PLC)
  • PID/RI diagrams
  • Technical data sheets for the components
  • Materials list (media and product carrying parts)
  • Weld logs
  • Testing for ease of access for maintenance and cleaning
  • Testing the media connections
  • Flowchart of the machine program
  • Test certificates for components from other manufacturers

Operational qualification (OQ)

Operational qualification is the testing and the documented certification that the criteria for correct machine operation are fulfilled as defined in the test schedule. The following steps can be included in the test schedule:

  • Operational inspection of the machine control (PLC inputs and outputs)
  • Operational inspection of the machine program
  • Calibration of measuring circuits
  • Operational inspection of the operating panel
  • Operational inspection of the safety equipment