INSIGHTS ON QUALITY CONTROL

  • The Definitive Guide To Particle Sizing

    This paper provides an introduction to particle sizing comparing six widely used techniques, explaining how they work and what this means in terms of strengths and limitations. 

  • Test Method Migration Considerations For CCIT

    In this webinar you will learn about important and critical considerations when shifting to a new or different inspection test method. Also covered is how to assess the test method accuracy, information, data analysis and how to carefully define method transfer objectives for each application. Site-to-site transfer of test methods will also be discussed in this presentation. 

  • New Method To Quantify Redispersion Potential Of Al Salts In Vaccines

    Adjuvants such as aluminum salt (Alum) are commonly added to vaccines to enhance their immune responses. A resulting sediment can be more or less compact and difficult to redisperse depending on the strength of the bonds between particles. In this note, we propose a rapid evaluation method (less than 30 minutes) of the sediment redispersibility.

  • Risk Mitigation Of Parenteral Packaging With Container Closure Integrity

    Parenteral delivery systems are the highest risk packaging application concerning container closure integrity. Leaks that register in the single micron range can introduce a threat of bacterial ingress.

  • Evaluating The Container Closure Integrity Of A Vial Using Headspace Gas Ingress Methods

    To ensure patient safety, pharmaceutical products must be kept properly packaged prior to use. Proper packaging prevents ingress of contaminants. Unfortunately, these contaminants are not always visible to the human eye and container closure integrity (CCI) tests must be performed to ensure the package has not been compromised. One way to test for proper CCI is to analyze the headspace gas composition of the vial.

QUALITY CONTROL SOLUTIONS

  • Rotational Viscometer: ViscoQC

    Developed for a wide range of applications, ViscoQC 300 ensures the quality of your substance – from almost any fluid to semi-solid samples – by delivering fully traceable viscosity results with a Peltier device for the most precise sample temperature control – right at your fingertips.

  • High-Risk Package Integrity Testing Systems

    The ongoing R&D of PTI continues to build a powerful set of leading-edge inspection technologies that will bring patented and unique solutions to high risk packaging applications. There is continuous development in the field of creating new test methods for container closure integrity, seal integrity testing and package integrity testing.

  • NuAire In-VitroCell™ ES Model NU-5710

    Model NU-5710 is a CO2 incubator that utilizes heating elements that surround the growth chamber on five sides. An independent door heater helps maintain temperature uniformity and reduce condensation. This direct heat model offers optimal cell growth conditions by producing humidity levels up to 95% and precisely controlling CO2 gas and temperature levels while minimizing potential contamination.

  • Abbemat Refractometer

    Measure the refractive index and concentration of liquids, gels and solids using laboratory refractometers from Anton Paar – the universally applicable and user-friendly Abbemat series. Simply take your pick depending on the accuracy, temperature range and level of automation you require - you can be sure to find a digital refractometer model to suit your application and budget.

  • HPAPI Package Inspection Enclosure

    The HPAPI Package Inspection Suite is designed to provide personnel and product protection down to a respiratory exposure of at least 100 micrograms per cubic meter air (100 ug/m3). Package inspection operations involve manipulation of highly potent pharmaceutical ingredients (HPAPI), such as fentanyl.