Reference

Cleaning validation of production facilities

A manufacturer of diagnostic products wants to provide evidence of the optimal cleaning of its production facilities. EXCO is going to contribute its knowledge to identify potential process residues and develop an analytical method including representative sampling for qualitative cleaning assessment.


EXCO Services
  • Analytical method development for the quantitative detection of very low concentrations with limit values in the ppm range
  • Creation of a residue profile
  • Process FMEA
  • Creation of validation protocol and report
  • Execution of practical validation tests in the laboratory
  • Chemical analysis
  • Liquid chromatography with mass spectrometry coupling
  • Training for representative sampling in ongoing production

Client benefits
  • Optimized methods
    EXCO experts optimize and validate methods so that the customer can continuously monitor his cleaning processes.
  • Compliant processes
    As a specialist for regulated industries, EXCO accompanies its customers as they work toward compliant processes that comply with all current guidelines of the life science industry.
  • High level of personal responsibility
    EXCO employees independently develop analysis methods tailored to the customer. One person responsible for the project is the point of contact from the draft concept to the validation activities and validation report.

Client

Global life science company

Your expert contact - Scientific Services

Natalie Burkhardt

T+49 171 8679535