INSIGHTS ON QUALITY ASSURANCE

  • Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage

    A vaccine-focused biotechnology company approached LIGHTHOUSE to help investigate a phenomenon observed in liquid vaccine product stored at -80°C. During QC testing, a number of vials were found to have an overpressure. This phenomenon represented a serious safety risk and LIGHTHOUSE was asked to support an investigation to identify the root cause.

  • Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing

    This application note details FDA released guidance titled “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products."

  • Advances In Temperature Calibration Procedures

    Recent developments eliminate the need for unnecessary calibrations and speed up the time it takes to do calibrations in the field.

  • Smarter Flowmeters For Filling Applications

    RONCHI MARIO developed its new filler around Endress+Hauser's new Dosimag and Dosimass flowmeters. The new filling machine generation of RONCHI MARIO S.p.A. features major innovations. Endress+Hauser's Dosimag and Dosimass flowmeters with integrated batching functionality are key components of the new machine concept.

  • Protecting Oxygen Sensitive Formulations Throughout The Product Life Cycle

    Many biopharmaceutical drug formulations have some degree of oxygen sensitivity. Topics for this webinar include how oxygen levels in finished parenteral drug containers can be determined for oxygen scavenger & stability studies, for determining inherent primary packaging integrity, and for optimizing & qualifying inert gas purging system during filling.

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QUALITY ASSURANCE SOLUTIONS

  • Analytical Development Services
    Analytical Development Services

    With thousands of methods developed, validated, and/or transferred in support of IND/ANDA/NDA/BLA applications, Nitto Avecia Pharma Services’ scientific team has a proven track record with nearly all drug forms, substances, and products.

  • Abbemat Heavy Duty Refractometers
    Abbemat Heavy Duty Refractometers

    Technology leader Anton Paar launches two new high-performance refractometers: Abbemat 450 and 650. The instruments combine extraordinary robustness with high precision up to ±0.00002 nD to measure the refractive index under harsh conditions.

  • Used Goring Kerr / Thermo Scientific Metal Detector
    Used Goring Kerr / Thermo Scientific Metal Detector

    Used Goring Kerr Metal Detector, model DSP3, with reject on stand, serial# 05573699.

  • Cleaning Validation (21 CFR Part 211.67)
    Cleaning Validation (21 CFR Part 211.67) Alconox, Inc. can assist you in selecting an appropriate cleaner for cleaning pharmaceutical manufacturing equipment and utensils to prevent malfunctions or contamination that would alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements.
  • Abbemat Heavy Duty Refractometers Brochure

    Anton Paar’s range of Abbemat refractometers embody over forty years of technical expertise. They are built with care and precision using the highest quality materials. Abbemat refractometers measure the refractive index and concentration of liquids, gels and solids. These truly universal refractometers cover a broad range of applications in all industries. Depending on the accuracy, temperature range and level of automation you require, a model is available to suit your application and your budget. An Abbemat is a secure investment for the future, providing reliable and accurate results for years to come.

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