Foreign Matter Analysis Service by Resolian

The size and count of particulate matter are critical factors when considering potential risk to patients.

Particulate matter testing forms part of the regulatory requirement to ensure unintended and non-therapeutic particulates in products do not exceed established limits.

DDS supports the following tests for both visible and sub-visible particles:

• USP <787> Sub-visible particulate matter in therapeutic protein injections
• USP <788> Particulate matter in injections 
• USP <789> Particulate matter in ophthalmic solutions 
• USP <790> Visible particulates in injection 
• USP <1788> Methods for the determination of particulate matter in injections and ophthalmic solutions 

Particle characterisation 
It is a regulatory requirement for manufacturers in the pharmaceutical and biopharmaceutical sector to be able to show a detailed understanding of their process. 

Consequently, there is increasing pressure on companies to be able to determine the identity and origin of such matter rather than to merely rely on the counting of the particles. 

Techniques 

• Sample isolation and preparation - ISO14644 Class 5 standard (FS 209 Class 100) laminar flow cabinets minimising sample contamination 
• Optical microscopy with image analysis 
• Light obscuration single particle counter 
• High Resolution Scanning Electron Microscope with EDX for qualitative elemental analysis 
• Fourier Transform Infra-Red (FT-IR) Spectroscopy and Microscopy Image Analysis 
• X-Ray Diffraction 
• Waters SynaptTM G2 high-resolution mass spectrometers (HRMS) with Ion Mobility 
• Inorganic analysis techniques e.g. ICP-OES, ICP-MS