Final Product Testing of Parenterals

The HIAC 9703+ liquid particle counter system consists of a sampler station, HRLD-sensor and the world-renowned Pharmspec Software. The system has been designed to meet all requirements from the different pharmacopoeias worldwide like EP/USP/JP/KP.

Final Product Testing Parenterals conform EP 2.9.19

The system is used for final product testing of parenterals and for parts cleanliness testing. The allowable limits of sub-visible particulates in parenteral formulations are described in Chapters <787>, <788> and <789> of the United States Pharmacopeia (USP), Particulate Matter in Injections and chapter 2.9.19 of the European Pharmacopoeia apply to most small- and large-volume parenteral products, particularly ready-to-use solutions for intramuscular, subcutaneous or intravenous (IV) injection.

Although light obscuration technology is generally the preferred testing method, it may be necessary to test some formulations using light obscuration and a microscopic particle count test to confirm compliance with applicable requirements.  The smart HRLD-sensors measure particle concentrations by optical light obscuration. Depending on the chemical composition, viscosity, particle concentration, required particle size range and the required sample volume the best suitable HRLD-sensor can be chosen for your system.

HRLD Smart Sensor

The term ‘smart sensor‘ refers to the fact that the calibration data are stored in the sensor itself, which gives the user the possibility to use more than one sensor with the same sampler station and to make use of a spare sensor in case a problem occurs with a sensor without having to ship the complete unit for service. The HRLD sensors can be applied within a very broad range for the flowrate and the maximum concentrations, which enables the user to test many different fluids. Fluids with a higher viscosity will require lower sample flowrates to avoid bubbles in the fluid solutions.

The 9703+ system has the capability to handle a full range of sample volumes with the smallest tare-volume of only 0.09 ml in the world. Pre-configured USP/EP/JP/KP test routines compendials are available to help you to take comply to the latest application requirements. With auto-flush routines and test recipe setup wizards, operators enjoy more walkaway operation with the HIAC 9703+.

On-site Calibration

CMI has in-house trained engineers that can calibrate your liquid particle counter conform ISO21501-2 and USP requirements. You can can use your liquid particle counter the same day after calibration.