Application: Gold Particle Testing

Gold Particle Testing

Validation and process integrity testing for Planova filters

Virus-removal filters are a key component in many biopharmaceutical manufacturing processes.

Challenges

  • The gold particle test is the most common and effective way to confirm that the filter pore size has remained unchanged throughout the process. 
  • Spectroscopic analysis of concentrated gold particle solutions pre- and post-filtration is the preferred method to validate chromatography filter and process integrity.

The SoloVPE Solution

  • Undiluted samples are measured using the SoloVPE System to generate section data. Linear regression analysis of the section data will yield a slope value which can be used for quantitation. 
  • The variable pathlength technology of the SoloVPE System dynamically adjusts the measurement pathlengths to suit the sample being measured and ensures that optimal readings are made. 
  • The use of multiple data points provides verification that the readings are compliant with the Beer-Lambert law. 
  • The context of the slope measurement inherently provides a greater level of confidence than a single absorbance data point.

The variable pathlength technology of the SoloVPE System dynamically adjusts the measurement pathlengths to suit the sample being measured, this ensures that optimal readings are made.

Webinars

Variable Pathlength Technology: Gold Particle Testing Viral Filtration Integrity

Learn why SoloVPE should be your primary system for UV-VIS spectroscopy and is ideal for gold particle testing. Variable pathlength technology allows for complete monitoring of the entire filtration process and requires no dilution for samples such as NIST gold-colloid solution. Learn more about the benefits of using the SoloVPE System in gold particle testing.

Application Services

Your success is our success

CTech is committed to our customers’ success. We design service offerings to supplement our standard support options and provide you with increased access to our highly knowledgeable and experienced professionals. We offer implementation, development, and educational guidance to maximize the benefits of your variable pathlength solutions and the Slope Spectroscopy® technique.

Application Services

  • 21 CFR Part 11 Guidance
  • Annex 11 Guidance
  • Validation Support
  • Qualification Service
  • Method Transfer Service

Development

  • Method Design & Development
  • Comparability
  • On-Site Support
  • Custom Standards
  • Process Auditing

Education

  • SOP Document Review
  • Advanced Slope Spectroscopy Training
  • Data Analysis
  • Maintenance & Troubleshooting

Contact a Bioanalytics Application Specialist

Your Partners in Method Development and Process Solutions.

Connect with our dedicated applications team. Our team can show you how to maximize the benefits of your variable pathlength solutions and the Slope Spectroscopy® technique. Let us help you expedite your SoloVPE Validation.

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