Recently we sat down with Emily Landsperger, Scientist II at Gateway Analytical, to discuss our new HIAC testing service for USP <788> and <789> Compliance. Read on to learn more about how Gateway has further expanded to meet customer demand.
What is HIAC?
HIAC stands for “High Accuracy” liquid particle counter. Liquid particle counters are commonly used to perform sizing and counting of particulate while in a solution.
How Does It Work?
The particles are detected by a light obscuration method, which is based upon the amount of light a particle blocks when passing through the detection window area of the particle counter.
What Size Range Can HIAC Analyze?
Most HIAC liquid particle counting systems can commonly count/size particles from 2-300µm, with additional detectors capable of counting/sizing submicron particles, or particles 300-1000µm in size. Here at Gateway Analytical, our HIAC system currently counts/sizes particles from 2-400µm.
When Can HIAC Be Useful?
Particle counting is a requirement of USP<788> “Foreign Particulate Matter in Injections” testing and HIAC is the recommended technique for Method 1. HIAC can also be used for samples, such as MDI and DPI samples for Foreign Particulate Matter studies, following the dissolution of the drug product. HIAC has many applications at different stages during a drug’s lifecycle; it’s also used across various industries. Examples of the use of HIAC (other than for USP methods) include vial washer studies, sampling tube studies, wear debris studies and hydraulic and lubricating oils contamination.
What Are The Advantages of a Method Like HIAC?
Liquid particle counting is a quick, cost-effective method for obtaining counting and sizing information for a sample. A single analysis can be completed in minutes and the results are highly accurate.
What Are The Disadvantages of HIAC?
Liquid particle counting can only provide you with the counting/sizing information; it cannot provide any additional information about the sample, such as particle identification, elemental information, photos, etc.
What Are The Next Steps After HIAC?
Orthogonal methods, such as automated Raman spectroscopy and automated scanning electron microscopy-energy dispersive spectroscopy (SEM-EDS), can provide characterization of the particulate, which can potentially lead to source determination of the contaminants. Raman spectroscopy characterizes the organic and some inorganic particulate, while SEM-EDS characterizes the inorganic and metallic particulate. The automation of the methods allows for the identification of an entire population of particles.
Learn more about HIAC Particle Counting for USP <788> and <789> Compliance or you can contact us for more details.