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


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.

Frequently Asked Questions

Particulate contaminants in pharmaceutical products can arise from various sources and may include foreign particles such as glass shards, metal fragments, fibers, or microbial contaminants. Common particulate contaminants encountered in pharmaceutical manufacturing include visible particles (>50 micrometers), subvisible particles (1-50 micrometers), and microbial particles (e.g., bacteria, fungi). These contaminants can originate from raw materials, packaging components, manufacturing equipment, or environmental sources. Particulate contamination poses risks to product quality, efficacy, and patient safety, necessitating rigorous quality control measures and analytical testing throughout the manufacturing process to detect and mitigate contamination issues.

Particle count testing in the pharmaceutical industry involves quantifying the number and size distribution of particles present in pharmaceutical formulations or manufacturing processes. This testing is critical for assessing product quality, ensuring compliance with regulatory standards, and identifying potential contamination issues. USP 788 has largely been accepted as the industry standard for particle count testing guidance.Common methods for particle count testing include light obscuration, microscopy particle counting, and dynamic image analysis. These techniques provide quantitative data on the concentration and size distribution of particles, enabling manufacturers to monitor and control particle levels within acceptable limits. The Aura family of instruments can identify, size and count microbial particles easily, accurately and quickly. Particle count testing is particularly important for injectable drug products, where excessive particulate matter can pose risks to patient safety, such as embolism or injection site reactions.

Controlling contamination requires implementing comprehensive quality control measures and adhering to good manufacturing practices (GMP). Key strategies for contamination control include:


  1. Facility design and maintenance: Designing facilities with controlled environments, proper ventilation, and segregated areas for different manufacturing processes to prevent cross-contamination.
  2. Personnel training and hygiene: Training on proper gowning procedures, hygiene practices, and aseptic techniques to minimize the risk of microbial contamination.
  3. Raw material and equipment control: Procedures for the qualification and validation of raw materials, equipment, and packaging components to ensure their suitability and cleanliness.
  4. Cleaning and sanitation: Establishing robust cleaning and sanitation protocols for equipment, facilities, and production areas to prevent microbial growth and cross-contamination.
  5. Environmental monitoring: Routine monitoring of air, water, and surfaces for microbial contamination to identify and address potential sources of contamination.
  6. Quality control testing: Performing analytical testing and inspection of raw materials, intermediates, and finished products to detect and mitigate contamination issues.
  7. Regulatory compliance: Adhering to regulatory guidelines and standards, such as government regulations, good manufacturing practices (GMP) and pharmacopeial requirements, to ensure product quality and safety.