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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