Maintaining Aseptic Barriers When Transferring Drug Product

By Matthias Angelmaier

When transferring products between different classified areas, the most important point is to maintain the aseptic barrier. Transfer systems and procedures are just as variable as the types of barrier systems. Hence, there are many different ways of bringing products and materials into barrier systems. A general distinction can be made between continuous (e.g. mouse hole, e-beam, sterilizing tunnel) and discontinuous transfer systems (e.g. rapid transfer ports, airlocks, liquid transfer systems). Besides many other sources, an important reference is ISO 14644. Since aseptic risk assessment also plays an important role, ISO 13408 is also worth considering.

There are many things to consider when transferring products and materials into barrier systems. It begins with categorizing the pharmaceutical product and defining the aseptic environment. How is my product categorized? What processes and procedures are commonly used? What are the major challenges in product and component supply? These and many other questions are a first baseline to start with.\

Continue reading to learn what to consider when planning aseptic production.