Cleaning Validation

Chromatogramm

Multipurpose systems used to produce pharmaceutical active ingredients or products in the batch process must be cleaned regularly with suitable procedures. In doing so, both active ingredient residues and cleaning agents must be effectively removed to ensure clean production facilities are available and to avoid cross-contamination.

Suitable and validated analytical methods, which are sensitive enough to detect the specified level of contamination, are to be used to verify the success of the cleaning process. The need for these analytical cleaning validation methods to be highly specific and sensitive is set out, along with other guidelines, in the FDA Guide to Inspections Validation of Cleaning Processes 7/93 [3]. This makes validating a cleaning process just as important as validating the manufacturing process.

Our services in the area of cleaning validation

With the help of our full range of analytical techniques, we can support you with your cleaning validations and verifications – down to the trace range and including documentation tailored to your needs. We have a comprehensive set of equipment for chromatography, mass spectrometry, and other techniques at our disposal for identifying and quantifying contaminants.

  • HPLC with standard detectors (DAD, UV, fluorescence, etc.)
  • HPLC-CAD (charged aerosol detection, e.g. for non-UV-active tensides)
  • HPLC/MS-MS
  • GC with standard detectors (WLD, FID, ECD, etc.)
  • GC/MS
  • A wide range of methods for determining sum parameters when substance-specific analytical methods are not required or cannot be used effectively.

These techniques enable us to reliably measure relevant substances – for example, in swab samples or final rinses that you have carried out.
We’re happy to offer you further methods on request. You can find an overview of the CURRENTA Analytics methods pool here.
You don’t need to invest in the necessary technology or in manpower, and you can concentrate on your core competencies, even for time-sensitive analyses. Of course, the scope of our services can be defined to suit your needs.

Efficient and competent

Our analyses help you:

  • Check and optimize the success of your cleaning processes,
  • Document your consistent compliance with limit values, and thus
  • Ensure the quality and safety of your pharmaceuticals.
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