Pre-Sterilised Components

Need a faster turnaround for your sterile vials? Afton Scientific’s Ready-To-Fill® Stock Program is the solution.

Afton Scientific’s Stock Ready-To-Fill® Vial Kits are composed of one stainless steel tray of vials, one pouch of stoppers and one pouch of seals. The vials are DI/WFI washed, re-packaged in 316 SS tray and dry heat depyrogenated. The stoppers and seals are re-packaged and steam sterilised.

All Ready-To-Fill® stock kits are processed using traditional cGMP validated methods. We provide testing data on all components as specified. A certificate of analysis is available with each batch.

14 reasons to use Afton Scientific’s Ready-to-Fill® stock kits

Less documentation to prepare for processing vials
No expensive washing and sterilising equipment to own, validate, maintain, and train operators to use
Less manufacturing space
Smaller WFI needs
No production scheduling for washing and sterilising components
No batch record to close out for washing and sterilising
Fewer deviations
No MOQ
Vials are DI/WFI washed, re-packaged in 316 SS tray and dry heat depyrogenated per a validated cycle
Stoppers and seals are re-packaged and steam sterilised per a validated cycle
Processed in a grade A cleanroom, (1) vial tray, (1) stopper pouch and (1) seal pouch are combined (not assembled), vacuum packed and heat sealed in (2) pre-sterilised LDPE bags
Trays are 3-sided for use in manual or automated filling
Vials and stoppers are sterility, endotoxin, and particulate tested
Seals are sterility tested

Afton Stock Kits showing glass vials with our branded trays

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Stock cGMP Ready-to-Fill® Sterile Vials

2ml, 13mm Kits

Afton Stock Kits Ready-to-Fill® Sterile 2mL, 13mm Vial

5ml, 20mm Kits

Afton Stock Kits Ready-to-Fill® Sterile 5mL, 20mm Vial

10ml, 20mm Kits

Afton Stock Kits Ready-to-Fill® Sterile 10mL, 20mm Vial

20ml, 20mm Kits

Afton Stock Kits Ready-to-Fill® Sterile 20mL, 20mm Vial

50ml, 20mm Kits

Afton Stock Kits Ready-to-Fill® Sterile 50mL, 20mm Vial

100ml, 20mm Kits

Afton Stock Kits Ready-to-Fill® Sterile 100mL, 20mm Vial

Frequently Asked Questions

We are inspected by the FDA, MHRA, and PMDA. Our clients also audit us accounting for ~15 audits per year.

Yes, we are cGMP compliant and inspected by multiple regulatory bodies.

Charlottesville, Virginia; Approximately 2 hours southwest of Washington DC and one hour west of Richmond, Virginia.

We ship worldwide.

Absolutely! We encourage customers to visit/audit our site and meet our team.

We can provide vial sizes 2ml – 100ml. We also work with 13mm and 20mm serum stoppers and aluminium seals. We keep the most popular sizes and types of component in inventory.

Our stock kit program includes Ready-To-Fill® kits with 2ml, 5ml, 10ml, 20ml, 50ml and100ml vials. These kits include sterile vials, sterile stoppers, and sterile seals ready to be filled in your clean environment.

We have experience working with all the major component manufacturers. We are happy to work with the manufacturers of your choice to procure the components. You can also ship us components from your inventory or have components drop shipped to us.

All incoming components are subject to release testing prior to use in manufacturing.

Yes, we have experience sterilising CZ vials and filling CZ vials.

We use traditional, commercial pharmaceutical sterilisation methods. Glass vials are dry heat depyrogenated; plastic vials, stoppers, and seals are steam sterilised in an autoclave. We do not use ETO or gamma sterilisation methods.

Yes, we can work with our tray manufacturer to create a tray that will suit your needs. If you already have a tray that you use, we can also discuss using this in our process.

No, our standard trays are one-time use. We can discuss reusability of custom trays on a case by case basis.

Yes. Prior to release all items are sterility tested. Vials and stoppers are tested for endotoxin. Particle testing for vials and stoppers can be conducted by an outside lab, if requested. Particle testing for vials and stoppers is performed on all stock Ready-To-Fill® kits.

The fully executed batch record and associated documentation is available upon request for all batches.

Ready-To-Fill® components have an expiry of two years from the date of sterilisation.