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Validation of the cleaning procedures for manufacturing or processing equipment
(including CIP and/or
SIP systems) is
required where:
Working with the client we will advise and provide the
essential initial cleaning evaluation studies in order to develop and
generate the necessary
cleaning validation master plan, sampling
methods, analytical methods and cleaning validation protocols.
The normal procedure is to perform swab and/or rinse sampling of the equipment surface and
test the
samples for residue. This analysis can be specific to the expected
contaminant (e.g. HPLC for drug substance), or it may be a non-specific technique such as
Total Organic Carbon (TOC)
analysis for water-soluble residues.
Total Organic Carbon (TOC) for cleaning validation has several advantages over specific
methods:
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Only one method is needed for all cleaning validation analysis
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The Total Organic Carbon (TOC) method is simpler to implement and easier to validate than
chromatographic techniques
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The method always produces a "worst-case" result, assuming that
all residue is the active substance
We work with clients to advise, develop and
validate techniques applicable to cleaning validation needs,
providing full
training and troubleshooting
support when required.
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