INSIGHTS ON QUALITY CONTROL

  • How To Understand ASTM E2500
    12/21/2020

    ASTM E2500 introduced the term “verification” but was essentially silent on the idea of “commissioning” and the term “qualification.” ASTM is a minimum standard, and teams are free to go beyond this minimum as long as the basic provisions are met. There are four basic approaches in the industry currently.

  • Water Activity Measurements And Microbial Contamination In Pharmaceutical Products
    6/19/2020

    Non-sterile pharmaceutical products are subject to microbiological examination prior to release and during stability testing. While the tests described in these chapters cannot be eliminated from protocol completely, USP <1112>, Application of Water Activity Determination to Nonsterile Pharmaceutical Products, suggests that water activity determination can be used to reduce the need for frequent microbial limit testing and screening.

  • Introduction To USP <922>: General Chapter For Water Activity Measurement
    6/19/2020

    The newly drafted USP <922> General Chapter describes the specific methods that pharmaceutical companies will use to calibrate, qualify, and use water activity instruments in their testing protocols. USP <922> includes a description of Tunable Diode Laser Absorption Spectroscopy (TDLAS) measurements and states that it is the only method to reliably and accurately measure water activity when the sample contains other volatile compounds. The Lighthouse FMS-Water Activity Analyzer uses TDLAS to non-destructively and directly measure the water activity non-invasively of samples in a sealed glass vial.

  • Raw Material Identification With Raman
    4/17/2020

    Anton Paar offers premier raman spectroscopy solutions for many pharmaceutical applications.

  • Headspace Gas Ingress Testing For CCI
    3/17/2020

    Imagine a blue dye test, but replace the dye with a tracer gas. Headspace Gas Ingress Testing is a robust detection method of critical leaks. It is a rapid, non-destructive, analytical measurement and can be scientifically validated. Are you considering to upgrade your blue dye test, and do you want to learn more about this approach? Watch this webinar.

QUALITY CONTROL SOLUTIONS

  • The Lovis 2000 M/ME is a rolling ball viscometer which unites an established measuring principle (Höppler, DIN 53015 and ISO 12058) with innovative and performance-enhancing features. More than 25 years of experience make Lovis 2000 M/ME a highly precise, versatile and time-saving viscometer. Lovis 2000 M/ME can be what you need it to be.

  • 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.

  • Integrated Glovebox and Hybrid Isolator for HPAPI Processing designed to provide personnel protection while working with powder substances.

  • The In-VitroCell ES (Energy Saver) NU-5810 Microbiological CO2 Incubator features a 145°C dry sterilization cycle and 95°C humidified decontamination cycle as an added defensive against incubator contamination providing an optimal controlled environment for cell growth

  • FMS/BioTrak/Portable/Remote/Environmental Sensors