Custom Solutions

As the original innovator, Afton has extensive experience with pre-sterilised components. We offer stock, off-the shelf options, as well as fully customisable products.

Many pharmaceutical companies are turning to pre-sterilised components for a multitude of reasons. Using pre-sterilised components can save time, money, and other key resources. Afton offers the most popular sizes and components in our Ready-To-Fill® stock program. However, we know that these won’t fit all applications. For those that need different packaging configurations, sizes, or specific components for their product or filling process, we offer many custom solutions.

Services offered

  • 2ml – 100ml vial sizes
  • Type 1 Borosilicate glass
  • 13mm and 20mm stoppers and seals
  • 3-sided, 4-sided, and custom trays
  • Custom packaging configurations for closures with your preferred quantity
  • Processed using traditional cGMP methods
  • Sterility, endotoxin, and particulate testing
  • COA issued with each batch

Exactly the pre-sterilised components you need for your next fill!

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Do you need a COA? Request one here!
Afton pharmaceutical expert

Need to procure components

We will help ensure you get the components you need by offering several options to procure components:

  • Afton stocks widely used components and sizes to use in custom configurations
  • Afton can procure your specified components
  • You can procure the components and ship to us for use in your project

Afton’s Ready-To-Fill® pre-sterilised components

No incoming inspection testing and release of raw vials

85%

Less documentation to prepare

65%

No expensive washing and sterilising equipment to own, validate, maintain, and train operators to use

83%

Less manufacturing space

70%

Smaller WFI needs

75%

No production scheduling for washing and sterilising components

62%

No batch record to close out for washing and sterilising

75%

Fewer deviations

79%
Afton pre-sterilised Ready-To-Fill® vials

Need a faster turnaround for your pre-sterilised components?

Afton’s Ready-To-Fill® stock program is the solution.

Each of our Ready-To-Fill® kits includes widely used sterile vial, stopper, and seal combinations that have been sterilised to pharmaceutical standards. Like our custom components, these kits are ready for immediate use in your sterile environment. This program is ideal for those who need a small quantity of Ready-To-Fill® components quickly.

SEE OUR READY-TO-FILL® KITS

Frequently Asked Questions

Are you inspected? By whom?

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

Are you cGMP compliant?

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

Where are you located?

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

Where can you ship items?

We ship worldwide.

Can we visit/audit?

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

What items do you offer?

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.

What sizes are offered in your stock program?

Our stock kit program includes Ready-To-Fill® kits with 2mL, 5mL, 10mL, 20mL, 50 mL and 100mL vials. These kits include sterile vials, sterile stoppers, and sterile seals ready to be filled in your clean environment.

Where do you purchase your raw materials?

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.

Do you have experience with plastic (CZ) vials?

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

What sterilisation method do you use?

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.

Can we use a custom tray for the vials?

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.

Do we have to return the trays after we use them?

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

Do you provide a COA with all items?

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.

What about other documentation?

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

What is the expiration dating for Ready-To-Fill® items?

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