With the new FlowCam LO from Yokogawa Fluid Imaging Technologies, users, for the first time, can acquire Light Obscuration data to match USP regulatory protocols, as well as verify their data with real images. All this can be achieved with a single instrument and a single sample run.
The FlowCam LO integrates Yokogawa Fluid Imaging Technologies’ patented flow imaging microscopy technology with an embedded light obscuration particle counter to provide you with the necessary data for USP regulations and validation with images.
While investigation with light obscuration is standard, the FDA has stipulated that size data collected with light obscuration is not enough to guarantee safe and effective drugs and that it is essential to provide validation and imaging data using orthogonal techniques. The FlowCam LO has an in-built orthogonal method.
The FlowCam LO offers:
- A better understanding of drug product formulation
- USP <787/788> compliance data with light obscuration
- Flow imaging microscopy validation of particle types with images
- Identification of extra particles overlooked by light obscuration alone
FlowCam LO Specifications
- Particle size range: 2 to 70 µm
- Flow cells: Flow imaging module: 80 µm x 700 µm quartz; LO Module: 1 mm x 0.4 mm quartz
- Sample processing capability: 0.2 mL/minute
- Light obscuration detection method: Light extinction, volumetric
- Frame rate: Shutters up to 100 frames per second
- Light obscuration light source: Solid-state laser diode, 785 nm
- Fluidics: Micro-syringe pump with 2.5 ml syringe
- Camera resolution of 1920 x 1200 pixels, available in color and monochrome
- Magnification: 2X, 4X, 10X, 20X
- Compatible with the Automated Liquid Handler (ALH for FlowCam)
- Minimum sample volume of 100 μL
- Autofocus capability
- Offers fluorescence emission and detection with excitation options at 488 nm, 532 nm, and 633 nm, featuring two-channel fluorescence detection
- Automated self-cleaning and self-rinsing cycles
- Comes equipped with the VisualSpreadsheet® image analysis software
- Optional software modules include VisualAI™ for automated identification of protein aggregates and silicone oil droplets, and a Compliance Package to support data integrity and regulatory requirements (e.g., 21 CFR Part 11)