INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Helium leak detection (HeLD) is routinely used and widely accepted for applications that require the utmost leak sensitivity. This brochure explains how Helium enables the discovery of extremely small microleaks that other leak testing methods cannot detect and what applications it can be used for.

  • Accelerate your production with the DE.SY.RE 1000, the fastest inspection machine in pharma. With speeds of 1,000 containers per minute, it ensures rapid market entry and exceptional inspection quality.

  • The Food and Drug Administration (FDA), United States Pharmacopeia (USP) and EMA Annex 1 issue strict guidelines for testing the integrity of IV bags and containers closed by fusion. IV bag manufacturers are one among many sterile product manufacturers that must meet these test requirements for container closure integrity.

  • Referenced in the new USP <1207> Chapter Guidance as a deterministic test method for container closure integrity testing.

  • Pharmaceutical and biotechnology manufacturers must ensure the quality of materials - from incoming raw material through finished product.