FEATURED ARTICLES

  • Pharma Process Validation: Initial Conclusions Are Often Deceptive

    As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.

WHITE PAPERS & CASE STUDIES

  • High Concentration Monoclonal Antibody Drugs Manufacturing Challenges

    A review of high-conentration mAb manufacturing challenges including viscosity, aggregation, instability, and the effect of excipients on formulation, filtration, and fill and finish and bioavailability.

  • Agglomerate-Free Dispersion For Hand Sanitizers

    Obtaining an agglomerate-free dispersion is essential to ensure a clear, bright gel after neutralization but low density powders such as Carbopol can be difficult to incorporate into liquids with a conventional agitator. The high shear mixing of a Silverson mixer ensures rapid incorporation and dispersion of powders to form an agglomerate-free solution, with minimized aeration.

PRODUCTS & SERVICES

The patented loading system for freeze dryers ensures maximum process safety, while saving a considerable amount of space. Thanks to its new front pusher design, the system loads vials into the freeze dryer using the linear pushing and pulling motion of a transfer arm. Unlike other systems, the innovative transfer bar is not moved by a hydraulic push rod, but by a mechanical servo drive.

Pharmatec Process Systems for Biopharmaceutical Production are designed for the production of liquid medicines. Production of pharmaceutical liquids is carried out in temperature-controlled stainless steel tanks with stirring units under addition of chemicals with or without nutrient solutions. All valid pharmaceutical (e. g. USP, EP) and technical rules and standards (e. g. DIN, ASME, GMP and FDA / ISPE Guidelines) are followed and applied.