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Cleaning Validations

USA:+1-908-534-4445

P.O. Box 470
291 Route 22 East
Salem Industrial Park
Whitehouse, NJ 08888
USA

Intertek provides cleaning validations for manufacturers and contract manufacturers of APIs, finished products, excipients and pharmaceutical packaging.

Sampling Techniques

Setting Acceptable Residue Limits (ARL)

ARL is critical in cleaning validations and should be logically determined
ARL must be practical, achievable and verifiable
Decomposition products should be checked
Initial criteria is visual check
10 ppm limit – USP limit test (assuming residues to be as harmful as heavy metals), useful for materials with no toxicology data available, not applicable for potent compounds
NMT 0.1% of therapeutic dose limit – minimum daily dose of current product carried over into maximum daily dose of subsequent product, identify worst case scenario

Analytical Methods

Develop and validate analytical methods for cleaning validations
Critical aspects are LOD, LOQ, precision, linearity, selectivity, recovery-spiking, consistency of recovery
Use validated methods for 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 specifically identify residue materials
Determination of Residual Micro 90
- For determination of the amount of residual Micro 90 left after the completion of cleaning procedure
- 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

Request more information to see how Intertek can help your organization with Cleaning Validations.