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| Intertek OCA Home > Intertek Pharmaceutical Services > Validation |
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Validation |
Cleaning Validation Services |
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Cleaning Validation:
Cleaning Procedures to be followed by:
- Manufactures and contract manufactures of APIs, finished products and excipients
- Packagers and contract packagers
- Sampling Techniques:
- Swabbing
- Rinsing
- Any other reasonable techniques
Setting Acceptable Residue Limits (ARL):
- Very important in cleaning validation; should be logically based.
- Must be practical, achievable, and verifiable.
- Decomposition products should be checked.
- First criteria - visually clean
- 10 ppm limit – pharmacopoeias limit test, assuming residues to be as harmful as heavy metal; useful for materials for which no toxicological studies are available; not for pharmacologically potent materials.
- NMT 0.1% of therapeutic dose limit – minimum daily dose of current product carried over into maximum daily dose of subsequent product; identify the worst case.
Analytical Methods:
- Develop and validate analytical methods for cleaning validation.
- Critical aspects to be considered- LOD, LOQ, precision, linearity, selectivity, recovery-spiking, consistency of recovery.
- Use the validated methods to perform routine analysis of cleaning validation samples
Non-specific methods:
- TOC:
- Useful for detecting all carbon containing compounds that are adequately soluble in water (which includes active species, cleaning agents and excipients)
- TOC methods are sensitive to ppb range and less time consuming
- Cannot identify exactly what the residue material is.
Determination of Residual Micro 90:
- Can be used to determine the amount of residual Micro 90 left after the completion of cleaning procedure
- Use UV/Vis detection
API Specific methods:
- Develop and validate methods to specifically identify and quantitate APIs (including biopharmaceuticals) after cleaning procedure.
- If an active drug is highly toxic, a specific method is always recommended.
Contact Intertek for more information.
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 Prefer to Call?
Americas: 1 908 534 4445, x669
Europe: +44 (0) 161 721 5247
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