Sterile 10mL Clear Open Vials, Ready to Fill, 24x50mm,Case of 435 pieces

Gerresheimer Open Sterile 10mL Vials — Ready-to-Fill / Ready-to-Use, Pyrogen-Free

These 10mL open sterile vials are manufactured by Gerresheimer® from USP Type I borosilicate glass and supplied in true Ready-to-Fill (RTF) / Ready-to-Use (RTU) condition — washed, depyrogenated, sterilized, and hermetically packaged so they can move straight onto your fill line without an additional prep step on your end. For 503A compounding pharmacies and 503B outsourcing facilities, that RTF/RTU status isn't a convenience feature — it's a direct reduction in the handling steps, validation burden, and contamination risk that come with processing your own glass in-house.

Why Ready-to-Fill Matters for Pharmaceutical Packaging

Vials that arrive washed, depyrogenated, and terminally sterilized let your facility skip the equipment, validation, and environmental monitoring overhead of processing raw glass under your own SOPs. That has a few concrete downstream benefits:

• Faster time-to-fill. Vials go from receiving straight to your cleanroom fill line — no depyrogenation oven cycle or in-house sterilization step to schedule around.
• Lower contamination risk. Every step — WFI wash, heat depyrogenation, ethylene oxide sterilization — happens under controlled, validated manufacturer conditions before the vials ever reach you, rather than being re-created on your own equipment.
• Simplified compliance documentation. Sterility and endotoxin testing reports are provided per lot, giving your quality team ready-made records for USP <797> CSP documentation and inspection readiness.
• Reduced capital and validation burden. No in-house depyrogenation tunnel or sterilization validation protocol required for this component — it arrives already qualified.

Product Specifications

• Nominal volume: 10mL
• Glass type: Clear USP Type I borosilicate
• Finish: Standard 20mm crimp finish (13mm hole opening × 20mm outer rim diameter)
• Outside diameter × height: 24 × 50mm
• Condition: Open, sterile, depyrogenated, pyrogen-free, Ready-to-Fill / Ready-to-Use (RTF/RTU)
• Case configuration: 435 vials per case, packed as 3 separate sealed trays of 145 vials each

Manufacturing & Sterilization Process

The glass is formed and washed using USP Water for Injection (WFI) by Gerresheimer®. The washed vials are then depyrogenated using heat and terminally sterilized using ethylene oxide by Sterigenics®. The finished vials are arranged in durable plastic trays and hermetically sealed, so sterility is maintained from the point of sealing until the tray is opened in your controlled environment.

Glass Quality & Chemical Resistance

USP Type I borosilicate glass is the pharmacopeial standard for parenteral and sterile-preparation packaging because of its resistance to chemical attack and leaching. Gerresheimer glass tubing used for this vial meets current United States, European, and Japanese Pharmacopeia glass grains testing requirements, with arsenic content below 0.1 ppm and lead, cadmium, mercury, and hexavalent chrome well below applicable TPCH/CONEG and EC regulatory limits. Finished vials are also inspected for proper annealing and for visual, mechanical, and dimensional characteristics before shipment.

Built for 503A and 503B Facilities

503A compounding pharmacies and 503B outsourcing facilities both rely on incoming components that are already qualified, documented, and ready to enter a controlled environment without additional processing. This vial's RTF/RTU status, per-lot sterility and endotoxin testing, and USP Type I glass certification are built around exactly that requirement — whether you're compounding sterile preparations under USP <797> or running larger-scale outsourced production, the component-level documentation is ready to drop into your own quality records.

Quality Documentation Included

USP sterility testing and bacterial endotoxin testing reports are available for every lot sold, to customers worldwide. This lot-specific documentation is available on request to support your facility's incoming-component qualification and inspection records.

Compatible Seals & Stoppers

20mm seals and stoppers sized to match this vial's crimp finish are sold separately on this website, so you can source your complete vial, stopper, and seal set from a single supplier.

Frequently Asked Questions

What does RTF/RTU mean for this vial?

Ready-to-Fill / Ready-to-Use means the vial has already been washed, depyrogenated, and terminally sterilized by the manufacturer. It arrives ready to go straight into your aseptic fill process without additional processing on your end.

What exactly is in a case of 435?

Each case contains 3 separate sealed trays of 145 vials each, for 435 vials total per case. Trays stay hermetically sealed until opened in your facility.

Is sterility and endotoxin documentation really included?

Yes. USP sterility and bacterial endotoxin testing reports are available for every lot we sell, worldwide, to support your incoming-component QC records.

Will the $550.00 clearance price stay available long-term?

No — this is clearance pricing tied to our current batch. It's available only while that batch lasts; pricing reverts to standard once it sells through.

Questions about lot documentation, volume pricing, or matching seals and stoppers? Contact us — we're happy to help you spec a complete vial, stopper, and seal solution for your fill line.