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.
HIAC 9703+ Particle Counter
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.
USP Compliance <787>, <788>, <789>
USP defines particulate matter as mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions. Further, it provides 2 tests for detecting subvisible particulates |light obscuration technology and microscopic assay. USP<788>, <787> and EP 2.9.19 are harmonized and state a preference for using the light obscuration counter, deferring only to the microscopic method when the light obscuration instrument cannot be used for some reason.
These instruments are generally accepted for use in testing:
  • Small-volume parenteral infusions/injectables (ampules and vials)
  • Large-volume parenteral infusions/injectables (IV solutions)
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+.
The 9703+ system
  • Expert SOP & IQ/OQ validation services available
  • Fully complies with the FDA ALCOA Guidance
  • Automatic database backup & recovery loss feature protects valuable results data
  • Pharmspec software ensures efficient compliance for 21 CFR part 11 environments
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.
Cleanroom Management International - QC Instruments - Quality Control Instruments
Monitoring
9703+ Liquid Counter Key Feutures
  • 21 CFR part 11 Compliance
  • Procedure Builder
  • Compliance to all Pharmacopoeias worldwide
  • Self Diagnostic features
  • User Conttrol via Microsoft Windows Active Directory
  • Compliance with USP <787>
  • Smallest tare volume of 0.09 ml
  • HRLD smart sensor for trouble free operations
PharmSpec Version 3.x
Pharmspec version 3.x is a Microsoft® Windows® application that is used with the HIAC 9703+  liquid particle counting system. PharmSpec collects and analyzes raw data from the liquid particle counting sensors using the USP, EP, JP or KP procedural standards, or user-defined test procedures.
  • Batch printing and exporting of reports
  • Company logo can be added to reports by the user
  • 64 bit support for Windows® 10 Pro and Windows 10 Enterprise
FDA 21 CFR part 11 Compliance
  • Test results can be reviewed and approved electronically
  • Historical data backup, restore and archive
  • View Activity Logs to comply with Audit Trails requirements
  • Historical reports (Archives)
  • Partial results are recorded for incomplete tests
Versatility
  • Data analysis of single or multiple runs done using the USP <787>, USP<788>, USP<789>, CP, EP, JP and KP procedural standards or user-defined test procedures (up to 16 channels)
  • Historical reports can be viewed, printed and exported (PDF, DOC, XLS or CSV)
  • Number of reviewer signature lines on printed reports is set by the user
  • Procedure Builder to make user-defined test procedures and report templates
Language Support
  • Local language support for French, German, Italian and Japanese
  • Reports can be displayed in local language or English on non-English systems
Software updates/Alarms
  • Automatic checks for procedure and software updates can be scheduled by the user
  • Alarms for invalid configuration, calibration due, bubbles detected, concentration limit exceeded, sample probe needs re-calibration, sensor blockage and sensor contamination
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