HIAC, a pioneer particle counting technology, revolutionized the industry by employing a laser light source for light obscuration sensors for particle counting, setting a benchmark for accuracy and reliability.
Our HIAC 9703+ system, coupled with PharmSpec Software, ensures compliance with stringent standards like USP<787>, <788>, and EP 2.9.19 for parenteral drug final product testing. Its unique design allows HEPA-filtered airflow from the cabinet to pass over the top of the glassware/vial to help prevent the risk of sample particulate contamination from the air, reducing the possibility of false-positive results.
The HIAC 9703+ Liquid Particle Counter can perform tests with just 1.0 mL of product up to very large (>1,000mL) volumes. Its automatic detection of bubbles and/or sensor contamination increases trust in particle counting results and the small vial holder ensures that expensive samples don’t get wasted.
The software, designed for ease-of-use and data integrity, features Microsoft Active Directory-controlled login credentials, multi-level user rights, automated pass/fail compendial reporting, a comprehensive audit trail, and auto-flush routines for improved walkaway operation.
Features
Essential features of our HIAC 9703+ Pharmaceutical Particle Counter
- Flexible sampling options; the light obscuration sensor can be calibrated at multiple different flow rates to make sampling easier for large-volume injectables and for viscous fluids.
- PharmSpec Software's SOP Programming: User-defined Standard Operating Procedures (SOPs) can be programmed into the counter, offering adaptability to specific testing requirements, and eliminating manual configuration and pass/fail calculations.
- Supports 21 CFR Part 11 ALCOA Compliance with multi-level user rights and a comprehensive audit trail.
- Use in laminar airflow cabinets to prevent sample particulate contamination from the air and reduce the possibility of false-positive results.
- Specially Designed Vial Clamp and Sampling Probe: The vial clamp securely holds samples in place, while the small-bore sampling probe enables the complete application of USP<787>, particularly beneficial for protein-based drug products like vaccines.
Applications
Applications of Liquid Particle Counting in the Pharmaceutical and Biopharmaceutical applications
- Small volume injectable (SVI)
- Large volume injectable (LVI)
- Research & Development
- Troubleshooting
- Stability Testing
FAQs
What are the benefits of using liquid particle counters?
The pharmaceutical and biopharmaceutical industries benefit significantly from using liquid particle counters, as these instruments provide critical insights into fluid cleanliness, optimizing manufacturing processes, and ensuring product quality and patient safety.
What is the lifespan of our liquid particle counter?
The lifespan of a liquid particle counter can vary depending on factors such as usage frequency, environmental conditions, and maintenance practices. Generally, well-maintained liquid particle counters can last for several years. Regular calibration, proper cleaning, and adherence to the manufacturer's guidelines for maintenance can contribute to the longevity and consistent performance of the instrument.
Can a liquid particle counter be used for both quality control and research?
Yes, liquid particle counters are versatile instruments that can be used for both QC and research applications. Their use for quality control of injectable drugs is well described but they can also help in a research laboratory to identify potential contamination that will affect results of studies.