Ray O'Connor, Operations Consultant, at the National Institute for Bioprocessing Research and Training (NIBRT) discusses the basics of biopharmaceutical facility design and operation. NIBRT provides training, educational and research solutions for the international bioprocessing industry in state-of-the-art facilities. Located in South Dublin (Ireland), it is based on an innovative collaboration between University College Dublin, Trinity College Dublin, Dublin City University and the Institute of Technology Sligo.
Q PTE: Why is aseptic processing crucial for injectables, such as vaccines and other biologic-based products?
Similarly, in the EU, GMP guidelines state that the manufacture of sterile products is subject to special requirements to minimise the risk of microbial contamination and of particulate and pyrogen contaminant. So, as a result, much of the aseptic process depends on the scale of training and attitudes of the people involved.
It's particularly important that this type of manufacture strictly follow established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects would not be placed on any terminal process or finished product testing. To summarise, aseptic processing is minimising the risk of introducing any microbial contaminant into your product as you move it through the manufacturing process.
Q PTE: Aseptic processing and the term 'fill–finish' are often used interchangeably throughout the industry. Are these two terms truly the same or are there unique steps for each?
O'Connor: Fill–finish is a discrete part of the manufacturing process. If you have an upstream or downstream process, that will be where you manufacture your active ingredient. Fill–finish is the filling and packaging part of this process. It comes after the product has been manufactured and is ready to be put into its final package container that the patient will see.
Aseptic processing refers to the various techniques that go into ensuring that the product is free of contaminants, thereby reducing the risk of infection to the patient. Aseptic processing is the processing of drug components, drug product containers and excipients in a manner that precludes microbial contamination of the final sealed product.