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General
  • Cleaning validation is a process to ensure that equipment cleaning procedures are removing residues to predetermined levels of acceptability. Although  "equipment cleaning" is part of  current Good Manufacturing Practice requirements the term "cleaning validation" was not popular until late 1980s.
  • The need for a systematic approach to proving the effectiveness of  all the cleaning procedures was  achieved in 1993 with a revised Food  and Drug Administration Inspection  Guide on Cleaning Validation.
  • The objective of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients and/or cleaning agents so that the analytical monitoring may be  reduced to a minimum in the routine  phase. In addition one needs to ensure  there is no risk associated with cross contamination of active ingredients.

Process

  • The analysis method used in cleaning validation must be sensitive and selective in order to detect and identify trace contaminants, and quantitative to report the extent of the contamination. Ion mobility spectrometry (IMS) meets all of these criteria and it is fast, much faster than HPLC, the method most commonly used in cleaning validation.

  • The Anatel  A-2000 Wide-Range Analyzer measures TOC in accordance with ASTM methods D 4779-88 and D 4839-88. It measures TOC directly by adding phosphoric acid to the water sample to reduce the pH to approximately 2 to 3. At this low pH any inorganic carbon that is present is liberated as CO2 into a nitrogen carrier gas and is directly measured by a non-dispersive infrared (NDIR) detector.

  • Techniques such as XPS and ToFSIMS give highly sensitive surface characterization from the uppermost 1-5nm of the surface. Furthermore, the condition of the surface can be assessed at the same time, for example, if cleaning is part of a passivation process, both residue content and degree of passivation can be characterized by looking at the species associated with the residue and metal : metal oxide ratios.

Technology

  • This is especially true for chromatographs and detectors. Isocratic and gradient reverse-phase high-performance liquid chromatography (HPLC) have evolved as the primary techniques for the analysis of non-volatile active pharmaceutical ingredients and impurities. The HPLC detector of choice for many types of methods development is the photodiode array (PDA) detector because it can be used for both quantitative and qualitative analysis.

  • This is especially true for chromatographs and detectors. Isocratic and gradien treverse-phase high-performance liquid chromatography (HPLC) have evolved as the primary techniques for the analysis of non-volatile active pharmaceutical ingredients and impurities. The HPLC detector of choice for many types of methods development is the photodiode array (PDA) detector because it can be used for both quantitative and qualitative analysis.

  • Residue is copyright software designed to calculate residue limits for actives in pharmaceutical cleaning validation for finished drug products. Users of this product are assumed to have a basic introduction to calculation of limits for finished drug manufacture.

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