Depyrogenation

Confidently Achieve Sterility Assurance Level Standards for Parenteral Products

Our line of depyrogenation products are ready to help you reduce the presence of pyrogenic substances to acceptable Sterility Assurance Levels (SAL) — including bacterial endotoxin contamination — through removal and inactivation processes. We will ship you fully prepared products along with full documentation and USP85 and USP71 Certifications. Vials have been exposed to HEPA filtered dry heat in a validated batch process that achieves acceptable levels of pyrogenic substances. In addition, our closures, stoppers, and seals are prepared by vigorous washing with USP & WFI water. Whether you prefer Type I borosilicate glass, butyl rubber, or aluminum seals, you’ll have packaging and shipping options. Plus you can choose single, double, or triple autoclavebag configurations for your cleanroom entry and ready-to-use application needs.

Advantages

  • Ready-to-Use Solutions: Prepared for cleanroom entry as well as fill and finish applications to improve workflow.
  • Flexible Configurations: For your convenience, sterilized components are available in stand-alone or kitted (with closures) small batch or large quantities.
  • Quality Assurance & Traceability: Components meet standards for depyrogenation and sterilization and ship with full documentation and certifications to complete your records.
  • Perfect Preparation: Dry heat and WFI rinse techniques are optimized to specific material compositions.
  • Workflow Focus: Single, double or triple autoclave bag options are available for cleanroom entry.