Pharmspec is particularly useful for:
Formed due to mechanical stress or temperature changes. pharmspec
Sub-visible particles (typically those between 2 µm and 100 µm) are a major concern for biotherapeutic products like monoclonal antibodies (mAbs). While they are too small to be seen by the naked eye, these particles can include: Pharmspec is particularly useful for: Formed due to
PharmSpec operates under strict regulatory guidelines: This is the minimum requirement for any facility
Pharmspec equipment is engineered to meet current Good Manufacturing Practice (cGMP) standards. This is the minimum requirement for any facility producing drugs for the US or European markets. Their machines feature stainless steel construction (usually SS304 or SS316L), smooth welds to prevent bacterial growth, and user-friendly PLC controls.
As particles pass through the laser, they cast shadows that the software interprets to determine particle size and concentration.