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. After filling, vials can undergo lyophilization if desired. 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: 2 mL – 50 mL
  • Capacity: up to 4,000 vials/batch 40 L of bulk solution (whichever is less), the maximum batch size for larger size vials is constrained by lyophilizer shelf space (3,800 for 20 mL vials, 2,900 for 30 mL vials, and 2,000 vials for 50 mL vials)
  • Components: molded or tubular glass vials
  • Peristaltic pump
  • UIP has extensive experience developing lyophilization cycles. To learn more about our lyophilization cycle development capabilities, please consult our Lyophilization Cycle Development Page

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