Aseptic Filling by AnovaFill™

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Aseptic Filling by AnovaFill

 

Pharmaceutical contract manufacturing allows companies to outsource development, manufacturing, and analytical needs.

Outsourcing is a common practice in the pharmaceutical industry as it improves chances of success, saves resources, and lets teams focus on other aspects of getting a product to market. Under our AnovaFill group, Afton provides cGMP contract manufacturing services to the industry. We help our clients with their projects, from process engineering optimization to manufacturing.

Pharmaceutical Contract Manufacturing Services Offered:

Aseptic Fill and Finish• Technology Transfer
• Formulation Optimization
• Process Optimization
• Aseptic Vial Filling
• Terminal Sterilization of Filled Vials
• Label/Pack/Serialization
• Analytical Services (link to lab page)
• Regulatory Filing Assistance

 

Our specialty is aseptic processing.

Aseptic processing is a technique that requires a lot of training and expertise to perform successfully. Each component is sterilized separately during this type of processing before being put together in finished form. At AnovaFill, the container (vials) is sterilized through the traditional method, dry heat in a depyrogenation oven. Closures (stoppers and seals) are sterilized through steam sterilization in an autoclave. The drug product is sterilized through sterilizing filters.
If your product can withstand the process, we also offer terminal sterilization. This is a sterilization process in which the components are brought together into the finished form and then sterilized simultaneously through steam sterilization in an autoclave.
At AnovaFill, we work with small-batch liquid injectables (1,000 to 30,000 units) intended for clinical trials and commercial markets. We specialize in scaling up from benchtop, and our experienced team is ready to help you get your product to clinic or market.

Types of Products:

• Suspensions
• Small and large molecules
• Monoclonal antibodies
• mRNA

Storage Conditions for raw materials and finished product:

• -80°C
• -25 to -15°C
• 2 to 8°C
• 20 to 25°C

 

AnovaFill has a history of successful NDA and ANDA drug registrations and audits by the FDA, PMDA, and MHRA.

Outsourcing drug manufacturing is a big decision. To help ensure that we are a good fit for you and your project, we invite you to schedule a technical visit. This allows you to meet our team face-to-face, tour our facilities, and get any questions you may have answered. Once you’re satisfied with our fit, we welcome your team to complete a formal audit.
At this time, we only offer filling of serum vials with non-cytotoxic, non-lyophilized, non-potent hormonal, and non-β-lactum products.

 

Contact us today for a confidential discussion.