Sterile pharmaceutical products are prepared by sterile filtering and then aseptically filling solutions into glass vials. The compounding area is equipped with an Enguard isolator to allow potent and cytotoxic APIs to be safely handled. Batch sizes can range from a few hundred vials to up to 4,000 vials or 40 L of bulk solution (whichever is less), depending on the fill volume of the product. Differential air pressures, along with other measures, including cleaning verification and dedicated product contact equipment components, are used to prevent cross-contamination.  Because our fillers use peristaltic pumps and a single fill needle, line losses are low compared to larger operations.

Vial Filling Detail:

  • Vial Sizes: 2 mL - 100 mL
  • Fill Volumes: 0.5 mL – 100 mL
  • Capacity: up to 4,000 vials/batch 40 L of bulk solution (whichever is less)
  • Components: molded or tubular glass vials
  • Peristaltic pump
  • ISO 5 (Grade A) aseptic work areas

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