Validation Testing for Bioprocessing Applications
Because of the wide range of potential applications, single-use aseptic connectors used in SUS come in a variety of configurations – from 1/8” microconnectors to 1” large volume connectors, from male/female to genderless, from standard to custom. These components must be optimized to maintain the integrity of the overarching manufacturing process. To achieve this, suppliers should engage in an array of testing that both simulates and exceeds manufacturing conditions, including several core tests that form a comprehensive validation model.
Reliability starts with building the test plan. Colder Products Company’s (CPC) product development teams work with integrators and end-users to understand the expected life cycle for their SUS components. By creating this framework, the teams are able to develop a test plan that mirrors predicted sterilization exposures, temperature induced stresses, and physical load induced stresses. From manufacturing to shipping, assembly to sterilization, and storage to usage, the wear and tear that a component can conceivably experience can be staggering.
Among the other tests CPC performs are accelerated aging, shipping and vibration, flow and burst, and biocompatibility testing to assess product durability and integrity. The testing profiles of its various components are available to biopharmaceutical manufacturers so they can evaluate components for integration in their manufacturing applications.
Bacterial ingress testing is one of the most important foundational tests for a single-use component. Sterility is custom equipment that simulates real-life product handling in the lab and field. Another key assessment for components utilized for bioprocessing are bioburden and endotoxin particulate tests, which are designed to validate that components are free of a range of living organisms (bioburden) and gram-negative bacteria (endotoxins) that could compromise a system.
Among the other tests CPC performs are accelerated aging, shipping and vibration, flow and burst, and biocompatibility testing to assess product durability and integrity. The testing profiles of its various components are available to biopharmaceutical manufacturers so they can easily evaluate components for integration in their manufacturing applications.
See for yourself CPC's test capabilities