Cleaning validation analytical services for highly specific and sensitive GMP quantification of detergents, cleaning agents and pharmaceutical product residues
Cleaning validation analysis helps to prevent contamination of drug products and ensures that the process and processing equipment are suitable for pharmaceutical manufacturing. Potential contaminants include residues of the active pharmaceutical ingredients (APIs), API degradation species, or residues from the cleaning process such as detergents or solvents.
Your focus will be to minimize any downtime in manufacturing and so once all key contact areas and equipment have been sampled you will require rapid and rugged analysis that is sufficiently specific and sensitive to detect the established acceptable residue levels (ARL) for contaminants.
Our expert scientists ensure that analytical methods are specific for the substances being assayed and suitable to detect contaminants at the ARL for an appropriate level of cleanliness (sensitivity). Our cleaning validation analytical programs include method development (or method transfer) and method validation where we focus on the critical aspects of LOD, LOQ, precision, linearity, selectivity, recovery-spiking, consistency of recovery.
With many years of experience in partnering with manufacturers around the world, we are able to develop highly specific methods for the more common residues, but also for the more complex, such as reaction by-products and degradation species. Our Good Manufacturing Practice (GMP) compliant laboratories are equipped with a wide range of techniques for both non-specific and specific API assays including high pressure liquid chromatography-mass spectrometry (HPLC-MS), ion chromatography (IC), inductively coupled plasma spectroscopy with mass spectrometry (ICP-MS) or optical emission spectroscopy (ICP-OES) detection.
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