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Particulate Matter Testing

Life Sciences / Central Laboratory Services / Microbiology / Particulate Matter Testing

Ensure Safety and Compliance

Particulate Matter Testing provides a total count of the number of visible or subvisible undissolved particles in your liquid injectable pharmaceutical or biopharmaceutical product. Our team performs these counts using laser diffraction instrumentation (USP <788>, Method 1) or through visual observation under a microscope (USP <788>, Method 2).

We are experienced with a wide range of product types, including:

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Particulate Matter Testing Methods

To provide you with a comprehensive service offering for particulate matter testing, we support both methods outlined in the United States Pharmacopoeia (USP) General Chapter <788> for your product. Method 1 involved an automated instrument method, whereas method 2 leverages a manual counting method using visual observation.

Light Obscuration Particle Count Test (Method 1)

We use the HIAC liquid particle counter system to test parenteral products for sub-visible particle content using light obscuration. This instrumental method is robust across a range of sample matrices with varying viscosities, coloration and solvent composition, and it also provides accurate and repeatable counts.

Microscopic Particle Count Test
(Method 2)

We use a binocular microscope with appropriate micrometers and related accessories to test your products for sub-visible particle content using the visual observation method. This method is used for confirmatory evaluations or when the nature of the sample matrix is not compatible (e.g. suspended gas bubbles, emulsions, certain buffered solutions or biologics) with the automated instrument and detection sensor. As a manual method, it offers advantages in reliability from added judgement and discernment but is often time-intensive to achieve acceptable accuracy and reproducibility.

Custom Particulate Matter Studies

Our team has the capabilities to design custom studies to count the particulates that are rinsed or sloughed from the surfaces of packaging, drug-delivery devices and systems, and medical devices in static and dynamic models. This may include simulations of device actuation or deployment using physical and chemical models. While particulate counting uses the same techniques, the procedures to extract, rinse, collect, and present the particulates in solution are researched and developed for the unique configuration, geometry, and drug-device combination product use. Data evaluation, product quality determination, and specifications development all require a risk assessment for product-specific applications.

Integrated Laboratory Services  

When your team needs additional support, our scientists & professional services are ready. Our state-of-the-art facilities and highly trained experts add power to your project.

Additional Resources

Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.