10mL Clear Sterile Open Vials, Depyrogenated, Case of 435 pieces

10mL Open Sterile Vial, Ready-to-Fill / Ready-to-Use — Case of 435 (3 Trays of 145)

Manufactured by Gerresheimer® from USP Type I borosilicate glass, this open sterile 10mL vial arrives washed, depyrogenated, terminally sterilized, and hermetically packaged — qualified to enter your fill suite without additional in-house processing. Component qualification, lot documentation, and supply consistency are built into every order, not sold as an add-on.

Technical Specification

Manufacturing & Qualification Chain

Glass tubing is formed and washed with USP Water for Injection (WFI) at Gerresheimer. Washed vials are depyrogenated by heat and terminally sterilized with ethylene oxide at Sterigenics, then arranged into hermetically sealed trays under controlled conditions. Gerresheimer glass tubing meets current USP, EP, and JP glass grains testing requirements, with arsenic below 0.1 ppm and lead, cadmium, mercury, and hexavalent chrome held below applicable TPCH/CONEG and EC regulatory thresholds. Finished vials are inspected for proper annealing and for visual, mechanical, and dimensional conformance before release.

Documentation Package

Every lot ships with the records your quality team needs on file for component qualification and inspection readiness:

• Certificate of Compliance — glass type, arsenic/heavy metals certification, hydrolytic resistance, converted product certification
• Sterility test report — USP <71>, direct method
• Bacterial endotoxin test report — USP <85>, LAL method
• Lot traceability — each lot number ties directly back to its own test reports and shipping record

Documentation is issued per lot, not per SKU, so the paperwork you receive matches the physical vials in your order — not a generic specification sheet.

Matching Components

20mm stoppers and seals sized to this vial's crimp finish are available separately, so your vial, stopper, and seal specification can be sourced and qualified as a matched set.

Request full lot documentation, a quote for standing or volume orders, or compatibility confirmation for your stopper/seal spec — contact IVPACKS directly.