Lab Services

Using Afton’s in-house lab services helps your project stay on time and budget.

Our quality control group is responsible for all incoming testing of raw materials, in-process testing, and finished product drug testing, including stability. All testing is performed to ensure that agreed-upon client specifications and regulatory requirements are met. Our highly skilled team will take your clinical or commercial product from method development and validation through all the steps needed for a successful regulatory filing.

Services offered

Method Development and Validation
Method Transfer
Excipient and Raw Materials Testing
In-Process Testing
Finished Product Testing
ICH Stability Programs
Regulatory Filing Assistance
Filter Validation
Shipping Validations
Testing Support

See how our dedicated team can move your project forward

Afton in-house lab services image of expert team member

Data Integrity & Protection

Data integrity is of the highest importance at Afton. Our labs are dedicated cGMP and 21 CFR Part 11 compliant so that all data being generated is accurate, complete, and consistent. All data generation and data analysis are tracked with verification through audit trails. Stability chambers are continuously monitored with temperature data auto-archived. Your success is our success, so we are dedicated to providing quality, on-time services.

ANALYTICAL CAPABILITIES

Assay by HPLC/UV-vis
Content Uniformity
Identification Testing
Related Compounds/Impurity Testing
Residual Solvents Testing

Forced Degradation Studies
Antimicrobial Effectiveness Testing
Container Closure Integrity Testing (CCIT)
Water Content/Moisture Analysis
USP Compendial Testing

Microbiology Capabilities

Sterility
Endotoxin
Osmolality
Density
Specific Gravity
pH Measurement
Bioburden

Frequently Asked Questions

CMO Sterile filling of parenteral products. We offer aseptic and terminal sterilisation 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.

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 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.

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

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

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

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

No, we do not have lyophilisation capabilities. However, we can provide pre-sterilised components for lyophilised products.

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

Yes, we have capabilities to manage stability testing programs.

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