INSIGHTS ON QUALITY CONTROL

  • Why A Modular Continuous Pilot Plant Might Be Your Flow Chemistry Solution

    There are still very few companies that have been able to successfully scale-up an API or intermediate with one or more continuous chemical process steps beyond the kilogram range under cGMP conditions. The best option to overcome the limitations in capital costs and timelines is known as a Modular Continuous Pilot (MCP) plant.

  • SAXSpace: Pharmaceutical Development

    The SAXSpace nanostructure analyzer is an ideal solution for SAXS analysis in pharmaceutical development, as a new additional technique to guarantee the safety of the final medication.

  • The Value Of Reliability Assessments And Benchmarketing In Life Sciences

    A global medical device manufacturer sought to improve Safety, Equipment Reliability, Overall Equipment Effectiveness (OEE), and cGMP regulatory compliance by performing a plant-wide reliability and best-practice benchmarking assessment. The goal: perform a thorough reliability assessment and benchmarking against industry standards, OSHA, and cGMP requirements to establish a reliability roadmap for moving the organization into regulatory compliance and industry best practice performance

  • Lipid Emulsions For Intravenous Application: Particle Size By DLS

    A common risk from intravenous infusions is contamination by particles that are not visible to the eye. Read how dynamic light scattering is a fast and accurate way to analyze the particle size and particle-size distribution, even with small sample amounts.

  • Risk Management And The Combination Product Testing Strategy
    4/8/2020

    Understanding combination product risks at the interfaces is critical. Components are often sourced at opposite ends of the globe and are proven to be robust due to investments in research, development and testing. It is essential to have an equal and complete understanding of all components where they come together at the interfaces where the risks are hidden.

  • Powder Shear Cell: Influence Of Humidity On Powder Characteristics Of Pharmaceutical Powders
    3/26/2021

    Ambient conditions can strongly impact the behavior of many powders. In real life, bulk solids will show different flowability depending on the geographical location in which they are handled. While the impact of humidity in a saturated state is relatively simple to simulate by conditioning the sample in a climate chamber, it is more complex to depict the dynamic process which actually takes place in reality. In this article the Anton Paar powder shear cell was used to determine different powder properties/processes like flow behavior and caking at a wide range of relative humidity (7% to 95%).

  • Measuring The Stiffness Of Hydrogels For Tissue Growth
    4/14/2020

    Hydrogels are very compliant materials suitable for tissue engineering in various areas of biological and clinical research. Appropriate and effective application of hydrogels for specific cellular regeneration often requires precise knowledge of their mechanical properties. This application report focuses on the measurements of mechanical deformation and creep properties of polyacrylamide hydrogels using the Anton Paar Bioindenter.

  • Oxidation Stability With RapidOxy
    4/16/2020

    RapidOxy is an automated Rapid Small Scale Oxidation Tester that provides oxidation stability analysis under artificial aging conditions for various products, including solid, semi-solid and liquid samples.

  • Dye Ingress For CCIT: A Poor Bet In A High Stakes Game
    3/23/2020

    The dye ingress test method continues to be a widely used test method for Container Closure Integrity. This paper explains why the dye ingress test method is not a suitable approach.

QUALITY CONTROL SOLUTIONS

  • Small-Angle X-ray Scattering, SAXS for short, is an increasingly popular technique for structural investigations in molecular biology, offering valuable complementary information to established techniques.

  • The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.

  • Stainlees Steel Glovebox for Cytotoxic Drug Development designed to provide personnel protection while working with powder substances.

  • SurPASS™ 3 is a high-end electrokinetic analyzer featuring fully automated zeta potential analysis of macroscopic solids in real-life conditions. SurPASS™ 3 employs the classic streaming potential and streaming current method for a direct analysis of the surface zeta potential. The zeta potential is related to the surface charge at a solid/liquid interface and is a key parameter for understanding surface properties and developing new specialized materials. Automatic pH scans and time-dependent recording of adsorption kinetics allow for a deep understanding of the surface chemistry.

  • The In-VitroCell ES NU-5820 Microbiological CO2 Incubator features relative humidity (RH) control for cell lines prone to desiccation by utilizing a sensor that measures humidity in the chamber and injects 99.99% HEPA filtered vapor into the growth chamber to maintain setpoint.