Cleaning validation analysis to support pharmaceutical production is critical to reducing the risk of drug product contamination, ensuring that 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 downtime in manufacturing whilst reducing risks to the patient. Once all key contact areas (service lines, gaskets filters, valves) and equipment (pumps, mixing chambers) have been sampled you will require rapid, and robust analysis that is sufficiently specific and sensitive to detect the established acceptable residue levels (ARL) for contaminants. The data generated validated analytical methods can be used to confirm a positive/successful cleaning validation.
Our analytical scientists provide cleaning validation analysis from our GMP compliant laboratories. We ensure that fit-for-purpose analytical methods are specific for the substances being assayed and suitable to detect contaminants at the specified 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. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
The GMP laboratories of Intertek Schweiz AG support the pharmaceutical industry with analytical services in the area of cleaning validation. Intertek develops and validates analytical methods for cleaning processes, conducts measurement campaigns, and thus helps eliminate risks from residues, impurities, and cross-contamination.
Acceptance criteria for product residues:
- According to the 10 ppm criterion, a maximum of 10 ppm of the previous product may be carried over into the next product.
- The 1/1000 dosing criterion states that the daily dose of the next product may not contain more than one thousandth of the lowest daily dose of the previous product.
Analytical methods for cleaning validation:
- Development and validation of analytical methods for cleaning validation.
- Critical aspects include LOD, LOQ, precision, linearity, selectivity, recovery, and reproducibility.
- Validated methods for routine analysis of cleaning validation samples.
- Sampling methods for cleaning validation:
- Wipe samples
- Rinse
Related services for cleaning validation:
