No longer is the biopharmaceutical industry questioning whether it should use single-use technology. The focus has transitioned to how to best implement single-use systems. Rapid adoption of single-use systems has brought added complexity; which is leading to an increasing application of lean manufacturing principles.

Standardization projects and establishing appropriate standards are current trends that drive toward reducing the complexity of bioprocessing systems, from design and validation to supply chain and manufacturing integration. Although efforts are underway to develop consensus standards for topics such as extractables and leachables and particulates, a number of drug and contract manufacturers are focusing on internal projects to standardize single-use designs across their processes and facilities.

As the market matures, more companies are likely to adopt modular system designs to build the facilities that support multidrug production. Incorporating a catalog of standardized bags, tubing manifolds and filter assemblies will be a strategy for creating complete systems that maintain process flexibility and drive greater efficiency. The resulting ability to purchase higher volumes of a smaller number of SKUs can help drive down lead times and reduce overall costs.

Creating closed systems that maintain sterility between these subassemblies will be achieved with sterile connectors. Using genderless sterile connectors can further simplify the design process. Connectors designed without male/female features enable any two connectors to mate. This design attribute in turn reduces supply chain complexity, eases manufacturing integration, and eliminates the potential of having two systems on the production floor that will not mate together.

For information on how your project can benefit from genderless AseptiQuik® technology, please contact CPC.

John Boehm is a business unit manager, bioprocessing, at CPC, 1001 Westgate Drive, St. Paul, MN 55114; 651.645.0091; [email protected]; cpcworldwide.com