What is USP 788?

The USP <788> Particulate Matter in Injections test is used to quantify the count and size of subvisible particles in parenteral drugs. The test calls for using a light obscuration particle counter and counting particles on a filter by microscopy.

What is particulate matter test?

Particulate Matter Testing. Light Obscuration Test. Based on the principle of light obscuration, this test allows for automatic determination of the number of particles according to their size. The test is performed in a biological safety cabinet, under conditions that limit foreign particulate matter.

Is USP 788 harmonized with EP?

The USP limits on particulate matter, harmonised with the European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP), are outlined in USP <788> “Particulate Matter in Injections”.

What is particle free water?

The definition for particle-free water is provided in Reagent Specifications under Reagents, Indicators and Solutions. The apparatus is calibrated using dispersions of spherical particles of known sizes between 10 µm and 25 µm. These standard particles are dispersed in particle-free water.

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 liquid particle counter?

Liquid particle counting is used to measure the size and distribution of particles in a liquid or on solid samples. The particle distribution and size are measured by irradiating a liquid sample with a laser diode and detecting the scattered light. The properties of the scattered light are related to the particle size.

How do you calculate particle count?

The second factor is the flow rate capacity of the particle counter. To do this you will need this formula: Vs = 20/Cnm) x 1000. Vs is the minimum single sample volume per location. Cnm is the class limit for the largest considered particle size specified for the class of your cleanroom.

How do you read a particle count?

So… the total number of particles in the 1 cc sample 6 µm and larger would be anywhere between 40 (remember the rounding?) and 80. The 14 µm and larger particle count is represented by 9 so the number of particles 14 µm and larger is somewhere between 28/100 and 29/100. 28= 256.

What size particles are visible?

The naked eye can see objects as small as 40 microns. As a point of reference, the diameter of a human hair is 70 microns, and a red blood cell is 8 microns.

How do you count particles?

Use the formula: Mass Number = (number of protons) + (number of neutrons). Arrange the formula to find numbers of neutrons: Number of neutrons = (mass number) – (number of proton).

How do you calculate the number of particles in a clean room?

Particle Counter Flow Rate & Location Sampling To do this you will need this formula: Vs = 20/Cnm) x 1000. Vs is the minimum single sample volume per location. Cnm is the class limit for the largest considered particle size specified for the class of your cleanroom.