ABSTRACT
The medical device industry has matured into hundreds of regulatory approvals worldwide, and with that has come a keen understanding of biocompatibility, leachability, and the safety of the plastic materials used. To date, no major regulatory authority has approved any product manufactured using a disposable bioreactor. It is not because of any risk factors in the use of disposable systems but in the inability of the manufacturers to file these applications. There are no extraordinary regulatory barriers in the deployment of disposable systems except the need to validate leachables. The use of disposables is supposed to reduce regulatory barriers substantially. The standard methods for validating radiation sterilization are often not clearly understood since the industry has mostly operated on using steam sterilization; however, a keen understanding of how irradiated components are validated is important for regulatory filing. The bacterial contamination can be serious, and sterilization validation may be required and validation necessitates complying with regulatory compliance.
