Screening Particulate Contamination In Pharmaceuticals

From development through lot release, get the assurance of quality and safety with USP 788 compliant subvisible and extrinsic particle data. Moving on from antiquated techniques not designed for life sciences, you'll have the power to make smarter decisions faster.

Step Up Your USP 788 Compliance Game

Vials_Resize

Why Use Aura for Assessing Particulate Contamination?

  • Achieve more accurate results with minimal amounts of sample (as little as 5 μL per test) so that multiple measurements can be made and averaged.
  • Achieve higher throughput for testing lots of candidates or conditions
  • Gather comprehensive data and insight into aggregate particles – size, morphology, counts, distribution
  • Get insights quickly with rapid analysis time of 1 minute per sample
  • Benefit from a wide working range: measures particles from 1 μm to 5 mm with high reproducibility
  • Image particles without the interference of buffer or matrix for higher sensitivity
  • Quantitate non-homogeneous particle populations (size, density, morphology)
  • Detect changes as a function of stress and solution conditions
  • Enjoy a user-friendly software interface

Detect Inorganic Contaminants

See the Unseen—Experience High-Contrast Particle Imaging Like Never Before

BMI breathes new life into membrane microscopy, replacing the tedious USP 788 subvisible particle lot release method, with modern robotics and automated imaging to generate accurate particle counts and sizing.

Built exclusively on Aura, this innovative technology can perform particle characterization on up to 96 samples in a single run using as little as 25 µL per sample.

BMI is also insensitive to solution refractive index, enabling reliable measurement of translucent protein aggregates.

The end result: USP788-compliant subvisible particle data, eliminating the need for LO and providing better insight into particulate contamination.

Granular Insights in Every Sample

Quantifying particle counts of historic USP size bins (>10 μm, >25 μm) is integral for accurate analysis, but being able to characterize particles <10 μm as well as determine if particles are intrinsic is just as essential.

With Aura’s SIMI and FMM technology combined with BMI's refractive index capabilities, you can now gain a deeper understanding of samples to identify protein or non-protein contents along with intrinsic or extrinsic elements—something that traditional flow-based particle analyzers could not provide. This allows for greater protection against costly recalls due to unseen particulate contamination.