Aseptic filling of sterile drugs is one of the most critical processes in pharmaceutical manufacturing. Let our experienced team take care of all your short-run parenteral drug aseptic filling needs. AnovaFill™ by Afton Scientific operates a cGMP facility designed and approved for aseptically manufactured or terminally sterilized parenteral pharmaceuticals for clinical trials and commercial filings.
We specialize in automated fill batch sizes from 100 to 15,000 units. We welcome small scale aseptic fills that may not meet the minimum vial requirement of other aseptic fill companies. AnovaFill™ supports a variety of finished dosage forms including small clinical trials up through small scale commercial batches. Our experienced team will work with you from start to finish, including assisting with the process development of your product’s formulation and regulatory filing assistance. We will perform any development and engineering work needed for special equipment, process and equipment validations to support regulatory filing, and pilot formulations. Once the development work is complete, we will formulate, fill/finish, label, and package your product to your specifications. We can assist you in scale up development and aseptic filling for projects ranging from pre-clinical to commercial, including orphan drugs.
Our focus is always the success of your product. We have in-house Engineering/Validation, Documentation, Quality Control, and Quality Assurance teams to support this focus and our facility. The facility is also supported by in-house WFI system, compressed air system, vial washing and depyrogenation capabilities, component sterilization, and QC microbiology lab. Other capabilities include nitrogen overlay, headspace analysis, standard validated filter assembly combinations, and material procurement.
AnovaFill™ has a history of successful NDA and ANDA drug registrations and audits by the FDA, MHRA, and PMDA.
AnovaFill™ provides an all-inclusive service to clients. From early clinical trials to small batch commercial runs, we can assist you from development to fill/finish. Whether your product is aseptically produced or terminally sterilized, AnovaFill™ can meet your sterile filling needs.
Contact us today for a confidential discussion.