Patients are administered parenteral drugs usually by means of injections, and therefore these drugs must be free of visible particles. To ensure this, the USP <788> Particulate Matter in Injections ...

Experiments were conducted to establish a laser diffraction-based method for the determination of lactose powder particle size. This was accomplished using a Bettersizer 2600 equipped with a fully ...

Flow imaging microscopy can be used to identify particulates and their sources. Subvisible particles (SVP) are a concern for biologic-based drugs. Some technologies can detect but not identify ...

The cleanliness of enclosures or parts is critical to avoid the presence of particulate contamination which can be bad for quality or performance. A good method to establish cleanliness is the ...

Individual units can be tested if there is an adequate volume. If the volume is not sufficient, the units are mixed, and the contents are combined to obtain the desired volume, typically in the range ...

According to study results, immunogenicity can be increased by protein aggregates and particles, thereby inducing immune responses to the protein’s monomeric form. The following are the steps followed ...