FAQ’s

Posted on

General Questions

  1. What type of products and services do you offer?

CDMO Sterile filling of parenteral products. We offer aseptic and terminal sterilization services for batches up to ~40k vials.

Ready-To-Fill® (RTF) sterile components (vials, stoppers, and seals). We have stock offerings of popular components packaged in a sterile, RTF kit or we can procure your specified components and process them.

  1. 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.

  1. Are you cGMP compliant?

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

  1. Where are you located?

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

  1. Where can you ship items?

We ship worldwide.

  1. Can we visit/audit?

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

Sterile Filling

  1. What types of products do you fill or not fill?

We have experience filling solutions, suspensions, biologics, pre-clinical, clinical, and commercial products.

We do not fill live vaccines, cytotoxics, high potency antibiotics, optic and opthalmics, powders, creams, or oral medications. If your product does not fall into any of these categories, we can discuss filling it.

  1. What size vials can you fill?

We have capabilities to fill 2mL – 100mL vials.

  1. What batch sizes can you fill?

We can fill batch sizes up to ~40,000 vials.

  1. Do you only fill for clinical trials?

No, we have experience formulating and filling commercial products. We can also provide commercial labeling, packaging, and serialization services.

  1. What are your sterilization methods?

We have capabilities for aseptic filling, as well as terminal sterilization.

  1. Can you perform lyophilization?

No, we do not have lyophilization capabilities. However, we can provide pre-sterilized components for lyophilized products.

  1. Do you have analytical capabilities?

Yes, we have in-house labs that can provide incoming testing, in-process testing during filling, release testing, and stability testing.

  1. Can you provide stability testing?

Yes, we have capabilities to manage stability testing programs.

  1. Can you provide label/pack/serialization services?

Yes, we can provide individual vial labeling or bright stock. We also have capabilities for commercial packaging and serialization of products.

Ready-To-Fill®

  1. What items do you offer?

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

  1. What sizes are offered in your stock program?

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

  1. 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.

  1. Do you have experience with plastic (CZ) vials?

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

  1. What sterilization method do you use?

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

  1. 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.

  1. 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.

  1. 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.

  1. What about other documentation?

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

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

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

Please Contact Us for a confidential discussion of your project.