Aseptic processing is one of the most critical steps in the production of biopharmaceuticals. It is uniquely challenging in its requirements for personnel and facilities. Avoiding contamination requires careful planning, effective personnel training, attention to detail on the part of technicians, and specialized facilities and equipment. These activities, skills, and facility features are necessary to avoid the high cost associated with re-processing and/or generating replacement lots. Most importantly, aseptic processing assures product safety, especially for injectable drugs, which rightfully receive intense scrutiny from FDA and other agencies.
The need to ensure high quality standards for these biologics creates heightened demand for robust practices and innovative solutions that reduce or avoid non-conformance. For Akron, this means understanding and implementing best practices, designing cleanrooms in a way that ensures that the necessary movement of people, materials, and equipment does not compromise the integrity of the final product, validating our aseptic processes, investing in personnel training and qualification, and maintaining equipment and cleanrooms. To mitigate or avoid non-conformance during aseptic processing, the following considerations are paramount:
- Identifying opportunities for single-use system implementation
- Remaining informed and implementing the newest technology in aseptic filling
- Determining how to eliminate risks of contamination during manual processing
- Systematic and robust personnel training and qualification
- Performing aseptic process validation (APV’s) and routine revalidations at least on a biennial basis to evaluate the state of control of aseptic processes.
Akron manufactures a broad range of biologics that require aseptic processing, as they are ultimately used to produce cell therapies. Because advanced therapies cannot be sterilized, we need to make sure that the components we produced are sterile. By investing in our people and in our facilities, we set ourselves up to get it right the first time, avoiding non-conformance or reprocessing. We work to make sure that our components are not only effective, but are safe for use in advanced therapies. By dedicating ourselves to manufacturing the highest quality products on the market, we ultimately reduce our customers’ overall costs. Learn more about our commitment to quality and our aseptic fill & finish services, then reach out to learn more about how we can support your development efforts.