What size are Subvisible particles?

Subvisible particles are usually defined as particles that are too large for analysis by size exclusion chromatography (SEC) (e.g., ~ > 0.1 μm), but too small to be visible to the unaided eye (e.g., < 100 μm).

What is the visible particle size permitted in LVP according to USP?

The size ranges used for USP <788> testing are ≥10 and ≥25 μm. Liquid particle counters are capable of sizing and counting particles ranging from 2μm to 200μm.

What is the difference between USP 787 and 788?

USP <787> provides refinement of <788> methods, specifically for the more sensitive protein therapeutic formulae. Microscopic method 2 does not provide useful quantitation of the protein fraction, but does recognize the isolated material and allow enumeration of the other (extrinsic and intrinsic) particles retained.

What does Subvisible mean?

: not visible without the aid of special instruments subvisible particles subvisible cirrus clouds For Great Lakes fishermen, the immediate threat is not the thumb-size grown-ups but the subvisible larvae they spawn by the tens of thousands.

What is sub visible particles contamination?

Subvisible particles (SVP) are a concern for biologic-based drugs. Some technologies can detect but not identify particles. “Knowing that subvisible particles are present-without seeing what they are-can only take you so far.

What is the permissible concentration of PM10 in the air?

The 24 hr mean concentrations of PM10 ranged between 69.3 to 118.9 microg m(-3), which is well within the permissible limit (150 microg m(-3)) of national ambient air quality standards (NAAQS) but found higher than the prescribed annual daily limit of US EPA (50 microg m(-3)).

What is particulate matter PM10?

PM10 are very small particles found in dust and smoke. They have a diameter of 10 micrometres (0.01 mm) or smaller. PM10 particles are a common air pollutant.

What is LBPC?

Liquid Borne Particle Count (LBPC)

What is light obscuration?

Light obscuration or Single Particle Optical Sensing (SPOS), is a high-resolution analysis technique capable of detecting a small percentage of outliers. Light obscuration works by passing a dilute stream of particles in a liquid suspension between a light source and a detector.

What is liquid particle counter?

The liquid particle counter operates on the principle that the light extinguished by a particle in a liquid within a laser beam is a direct function of its area. The pulses produced by electronically detecting the total laser light minus the light obscured by the particle are used to size the particle.

What is particulate matter testing?

Particulate Matter testing includes procedures for removing, counting, and sizing particulate contaminants in injections, parental infusions, opthalmic solutions and various medical devices. Simulated use testing can also demonstrate the amount of particulate matter shedding from the use of a device.

What do you need to know about subvisible particles?

Subvisible particle characterisation requirements extend to particle size, number, shape, optical properties and chemical identification, and increasingly includes submicron particles. Both USP <787> and <788> recommend the technique of light obscuration (LO) for the sizing and enumeration of subvisible particles.

How big does particulate matter need to be?

Background: USP Particulate matter can be defined by size: • Visible particles: ≥ 100 μm • Sub-visible particles: < 100 μm And by source: • Inherent • Intrinsic

What are the USP requirements for particulate matter?

Background: USP Particulate matter can be defined by size: • Visible particles: ≥ 100 μm • Sub-visible particles: < 100 μm And by source: • Inherent • Intrinsic • Extrinsic USP<1> “Should be prepared in a manner designed to exclude particulate matter” “Each final container of all parenteral preparations should be inspected to the extent

Can a subvisible particle pass through an in line filter?

Even with the 0.22 micron in-line filters used for intravenous administration, a large fraction of the submicron particles can readily pass through and be delivered to the patient. In summary then, developing knowledge of the provenance and impact of subvisible particles is a vital strategy for engineering stability and safety into a product.