FAQ

Yes. We develop and validate CCIT methods tailored to your specific packaging configuration. Validation includes sensitivity studies (spiked samples with known defect sizes), specificity testing, and correlation to microbial challenge data per USP <1207> recommendations.

The MALL is the leak rate that corresponds to the maximum leak size that could compromise sterility — typically considered to be approximately 0.1–1.0 μm for most sterile products. Our vacuum decay method (LOD 1 μm) can reliably detect leaks at or below the MALL for most applications.

Because no single method can fully describe complex particles across all sizes, structures, and sample matrices. Orthogonal methods strengthen confidence in key CQAs such as size distribution, concentration, morphology, and aggregation.

We select methods based on particle type, expected size range, polydispersity, and matrix effects. A typical study may combine screening, separation-based, particle-by-particle, and imaging methods to build a reliable interpretation.

We usually need the product modality, concentration range, formulation or buffer details, and intended use such as development, comparability, stability, or release support. If target CQAs or specifications are available, we align the study plan accordingly.

Differences can result from sample heterogeneity, matrix effects, or the measurement principles of each method. We review preparation, working range, and orthogonal evidence to provide a consistent interpretation and practical next steps.